Evidence-based treatment algorithms for daily oncology practice — biomarker-first decision support, integrated with the latest NCCN and ESMO guidelines, and linked directly to clinical calculators at the point of decision.
Produce a structured weekly oncology clinical-management update by scanning major oncology data sources and entering verified trial results, regulatory actions, guideline changes, and safety signals into a multi-tab spreadsheet.
Use this page whenever you need a weekly oncology or cancer clinical update, or when checking oncology news from NCCN, ASCO, ESMO, AACR, FDA, UpToDate, JCO, NEJM, The Lancet, Medscape.
Weekly Oncology Clinical Trial Updates
Curated weekly summaries of practice-relevant oncology trial results, regulatory approvals, and guideline updates sourced from NEJM, AACR, ASCO, ESMO, FDA, and peer-reviewed journals.
CAR-PRISM (ciltacabtagene autoleucel) — Haematology, Phase II
Presented at: AACR 2026
Population: High-risk smoldering MM per 20/2/20 model; excluded if >40% BM plasma cells; ECOG PS 0-1; median age 58
Intervention: Cilta-cel (Carvykti) single infusion after lymphodepletion; no induction or bridging therapy
Primary endpoint: MRD negativity — 100%
Conclusion: Cilta-cel as primary therapy induced deep and durable responses in high-risk smoldering multiple myeloma, with 100% MRD negativity and no progression to active disease at median 15.3 months follow-up.
Clinical impact: Early signal
FDA status: Approved (Carvykti approved for RRMM 2024; this study explores new indication in SMM)
IDeate-Lung01 (ifinatamab deruxtecan) — Lung, Phase II
Presented at: WCLC 2025
Population: Adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy; ≥1 prior line; measurable disease; ECOG PS 0-1
Intervention: I-DXd 12 mg/kg IV Q3W
Primary endpoint: ORR (BICR) — 48.2%
Median PFS: 4.9 months
Median OS: 10.3 months
Conclusion: If approved, ifinatamab deruxtecan would be a first-in-class B7-H3 directed DXd ADC for previously treated ES-SCLC.
Clinical impact: Informative
FDA status: Pending — Priority Review granted Apr 13, 2026; PDUFA Oct 10, 2026; Breakthrough Therapy Aug 2025
Population: First-line HLA-A*02:01-negative metastatic uveal melanoma; age ≥18; ECOG PS 0-1; measurable disease; no prior systemic therapy in metastatic setting
Intervention: Darovasertib + crizotinib
Primary endpoint: PFS (BICR) — 37.1% vs 5.8%
Median PFS: 6.9 vs 3.1 months
Conclusion: OptimUM-02 is the first randomized study to demonstrate a statistically significant and clinically meaningful benefit in PFS in first-line HLA-A*02:01-negative metastatic uveal melanoma.
Clinical impact: Informative
FDA status: NDA submission planned H2 2026 (accelerated approval sought)
Population: Patients with metastatic colorectal cancer
Intervention: N/A
Primary endpoint: N/A — N/A
Conclusion: The 2026 ESMO Clinical Practice Guideline highlights precision oncology in mCRC, with treatment decisions shaped by molecular biology and refined therapeutic sequencing including anti-EGFR rechallenge.
Conclusion: The first month of ICI therapy is the crucial period for determining risk of myocarditis fatality. Early-onset myocarditis and cardiorespiratory coreactions are the top predictive features.
Population: Patients with histologically confirmed oral epithelial dysplasia (mild to severe); high risk of progression
Intervention: Intralesional nivolumab 10 mg or 20 mg every 3 weeks × 4 doses
Primary endpoint: Safety / lesion area reduction — N/A
Conclusion: Intralesional nivolumab is safe, well tolerated, and results in efficacy rates unparalleled by other nonsurgical methods, sparing surgery for the majority of patients with precancerous oral lesions.
Conclusion: Teclistamab plus daratumumab demonstrated deeper and more durable responses than standard Dara-based regimens in RRMM after 1–3 prior lines of therapy.
Clinical impact: Regulatory
FDA status: Approved Mar 5, 2026 — traditional approval for RRMM with 1–3 prior lines (CNPV pilot)
Conclusion: Nivolumab plus AVD is a new standard of care for previously untreated advanced classical Hodgkin lymphoma, improving PFS while being better tolerated than BV+AVD.
Clinical impact: Practice-changing
FDA status: Approved Mar 20, 2026 — 1L Stage III/IV cHL (traditional approval); also traditional approval for 2 R/R cHL indications
ROSELLA (relacorilant + nab-paclitaxel) — Gynaecology, Phase III
Presented at: SGO 2026
Population: Platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer; 1–3 prior lines; prior bevacizumab required; ECOG PS 0-1; progression <6 months after last platinum
Intervention: Relacorilant 150 mg PO day before, day of, and day after nab-paclitaxel + nab-paclitaxel 80 mg/m² IV D1,8,15 Q28D
Primary endpoint: PFS (BICR) and OS (co-primary) — Not reported
Median PFS: 6.5 vs 5.5 months
Median OS: 16.0 vs 11.9 months
Conclusion: Relacorilant plus nab-paclitaxel reduced the risk of death by 35% compared to nab-paclitaxel alone, extending median OS from 11.9 to 16.0 months in platinum-resistant ovarian cancer.
Clinical impact: Regulatory
FDA status: Approved Mar 25, 2026 — platinum-resistant ovarian/fallopian tube/peritoneal cancer (1–3 prior lines, prior bevacizumab required)
Primary endpoint: PK non-inferiority / efficacy — Not reported
Median PFS: Not reported months
Median OS: Not reported months
Conclusion: Subcutaneous toripalimab provides comparable pharmacokinetics, efficacy, and safety to intravenous administration in first-line treatment of advanced nsqNSCLC, offering a more convenient and resource-efficient alternative.
Primary endpoint: MRD negativity (10⁻⁵ sensitivity) and PFS (co-primary) — 97.1% vs 94.3%
Median PFS: NR vs NR months
Median OS: NR vs NR months
Conclusion: Daratumumab plus VRd as induction and maintenance significantly improved MRD negativity rates and PFS compared to VRd alone in transplant-ineligible NDMM.
Clinical impact: Regulatory
FDA status: Approved Jan 27, 2026 — traditional approval for transplant-ineligible NDMM (CNPV pilot)
Intervention: Pembrolizumab 200 mg IV Q3W + paclitaxel 80 mg/m² IV weekly
Primary endpoint: PFS — Not reported
Median PFS: 12.1 vs 8.4 months
Conclusion: Pembrolizumab plus paclitaxel significantly improved progression-free survival in patients with platinum-resistant ovarian cancer with PD-L1 CPS≥1.
Clinical impact: Regulatory
FDA status: Approved Feb 10, 2026 — traditional approval for platinum-resistant ovarian/fallopian tube/peritoneal cancer, PD-L1 CPS≥1, 1–4 prior lines (CNPV pilot)
AMPLIFY (acalabrutinib + venetoclax) — Haematology, Phase III
Presented at: ASH 2023
Population: Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least 1 prior line of therapy; age ≥18; ECOG PS 0-2
Intervention: Acalabrutinib 100 mg PO BID + venetoclax 400 mg PO QD (5-week ramp-up) × 24 months; obinutuzumab optional first 6 cycles in CLL
Primary endpoint: PFS — 73% vs 47%
Median PFS: NR vs NR months
Median OS: NR vs NR months
Conclusion: The acalabrutinib and venetoclax combination reduces the risk of disease progression or death by 52% compared to standard BTK inhibitor-based therapies in relapsed or refractory CLL.
Clinical impact: Regulatory
FDA status: Approved Feb 19, 2026 — traditional approval for relapsed/refractory CLL/SLL after ≥1 prior line (CNPV pilot)
Intervention: Encorafenib 300 mg PO QD + cetuximab 500 mg/m² IV Q2W + mFOLFOX6 (oxaliplatin 85 mg/m² + leucovorin 400 mg/m² + 5-FU 400 mg/m² bolus then 2400 mg/m² over 46h) Q2W
Primary endpoint: PFS (BICR) — 67% vs 24%
Median PFS: NR vs 11.3 months
Conclusion: Encorafenib plus cetuximab with mFOLFOX6 is a new standard first-line treatment option for patients with BRAF V600E-mutated metastatic colorectal cancer.
Clinical impact: Practice-changing
FDA status: Approved Feb 24, 2026 — traditional approval for BRAF V600E-mutated mCRC (1L) (CNPV pilot)
Population: Muscle-invasive bladder cancer (MIBC, cT2-T4aN0M0) eligible for radical cystectomy; ECOG PS 0-1; adequate organ function
Intervention: Neoadjuvant: enfortumab vedotin 1.25 mg/kg IV D1,8 + pembrolizumab 200 mg IV D1 Q21D × 3 cycles → radical cystectomy + pelvic lymph node dissection → adjuvant: pembrolizumab 200 mg IV Q21D × up to 13 cycles
Primary endpoint: EFS
Median PFS: NR vs 46.3 months
Conclusion: Perioperative enfortumab vedotin plus pembrolizumab significantly improved pathological complete response rate, disease-free survival, and event-free survival compared to neoadjuvant gemcitabine plus cisplatin in muscle-invasive bladder cancer.
Clinical impact: Informative
FDA status: Approved (Padcev traditional approval for cisplatin-ineligible locally advanced or metastatic urothelial cancer; this trial supports perioperative MIBC indication)
ILUSTRO (zolbetuximab + mFOLFOX6 + nivolumab) — GI, Phase III
Presented at: ASCO GI 2026
Population: Previously untreated, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma; CLDN18.2-positive (≥75% tumor cells with moderate-to-strong membranous staining); ECOG PS 0-1
Intervention: Zolbetuximab 800 mg/m² IV loading + 600 mg/m² IV Q3W + mFOLFOX6 (oxaliplatin 85 mg/m² + leucovorin 400 mg/m² + 5-FU 400 mg/m² bolus then 2400 mg/m² over 46h) Q2W + nivolumab 240 mg IV Q2W
Primary endpoint: PFS (BICR) — 63% vs 58%
Median PFS: 10.2 vs 8.5 months
Median OS: 18.2 vs 15.6 months
Conclusion: The addition of zolbetuximab to mFOLFOX6 plus nivolumab significantly improved progression-free survival and overall survival in CLDN18.2-positive, HER2-negative gastric or GEJ adenocarcinoma.
Population: Postmenopausal patients >50y with cT1N0 (US-negative), HR+/HER2-, G1-2 breast cancer for SLNB omission; pT1-T3 pN+ M0 for OFS duration; HR+/HER2- for MammaPrint assay
Intervention: SLNB omission + whole-breast RT + ET for selected patients; OFS 5yr + AI/tamoxifen; MammaPrint 70-gene assay for anthracycline benefit
Primary endpoint: N/A — N/A
Conclusion: SLNB omission may be considered in selected postmenopausal HR+/HER2- cT1N0 patients receiving whole-breast RT and ET. OFS 5yr is optimal for pN+ disease. MammaPrint identifies patients who benefit from anthracyclines.
Intervention: Datopotamab deruxtecan 6 mg/kg IV Q3W as preferred 2L; sevabertinib as preferred for HER2-mutant; osimertinib+chemo Category 1 1L
Primary endpoint: N/A — N/A
Conclusion: Datopotamab deruxtecan is now a preferred second-line regimen for EGFR-mutant NSCLC after progression on frontline osimertinib plus chemotherapy. Osimertinib plus platinum-based chemotherapy and amivantamab plus lazertinib are Category 1 preferred first-line options.
Conclusion: Belantamab mafodotin plus bortezomib and dexamethasone is now a Category 1 preferred regimen after 2 prior lines. Linvoseltamab is included as an option after 4 prior lines. Isatuximab plus VRd is Category 1 preferred for transplant-eligible newly diagnosed patients.
OSPREY / CONDOR (piflufolastat F 18) — GU, Phase II/III
Population: Men with prostate cancer: suspected metastasis candidates for definitive therapy; or suspected recurrence based on elevated PSA
Intervention: Pylarify TruVu 333 MBq (9 mCi) IV bolus, imaging ~60 min post-injection. New formulation with enhanced stability at higher radioactive concentrations.
Conclusion: Pylarify TruVu is a new formulation of piflufolastat F 18 injection approved for PET imaging of PSMA-positive lesions in men with prostate cancer. The formulation enables ~50% larger batch sizes and extended shelf life, potentially expanding patient access to PSMA PET imaging.
DESTINY-Breast05 (trastuzumab deruxtecan) — Breast, Phase III
Presented at: ESMO 2025
Population: HER2+ (IHC 3+ or ISH+) early breast cancer with residual invasive disease after neoadjuvant HER2-targeted therapy; high risk (inoperable at presentation or pathologically positive axillary nodes post-neoadjuvant)
Intervention: Trastuzumab deruxtecan 5.4 mg/kg IV Q3W
Primary endpoint: IDFS — N/A
Median OS: NR (immature, 2.9% maturity) months
Conclusion: Trastuzumab deruxtecan demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival compared with T-DM1 in patients with HER2-positive early breast cancer with residual invasive disease after neoadjuvant therapy.
Clinical impact: Informative
FDA status: Pending — Priority Review granted Mar 9, 2026; PDUFA July 7, 2026; Breakthrough Therapy Designation Dec 2025
Population: Advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer with HRD+ status (BRCA mutation and/or genomic instability) following response to first-line platinum-based chemotherapy
Intervention: MyChoice CDx: NGS of BRCA1/2 (including large rearrangements) + tumor genomic instability score (LOH + TAI + LST)
Primary endpoint: PFS (HRD+ population) — N/A
Median PFS: 21.9 vs 10.4 (HRD+) months
Median OS: NR vs NR (HRD+, final OS) months
Conclusion: MyChoice CDx is now the only FDA-approved companion diagnostic for niraparib, identifying HRD-positive patients through comprehensive BRCA1/2 and genomic instability assessment. Nearly 50% of patients with advanced ovarian cancer have HRD+ tumors.
Clinical impact: Regulatory
FDA status: Approved Mar 2026 — MyChoice CDx as companion diagnostic for niraparib in ovarian cancer
Population: All patients receiving capecitabine or 5-FU for any indication (CRC, breast, gastric, esophageal, pancreatic cancers)
Intervention: Mandatory DPYD genetic testing prior to initiation (unless immediate treatment necessary); dose reduction for partial DPD deficiency; avoidance for complete DPD deficiency
Primary endpoint: N/A — N/A
Conclusion: The FDA updated capecitabine and 5-FU labeling to require DPYD genetic testing prior to initiation, with avoidance in complete DPD deficiency and dose individualization in partial deficiency. A boxed warning now highlights the risk of serious or fatal toxicities.
Clinical impact: Regulatory
FDA status: Approved Feb 2026 — Safety labeling update (Boxed Warning, Dosage section 2.1, Warnings and Precautions)
Conclusion: KROCUS trial evaluating first-line fulzerasib plus cetuximab in KRAS G12C-mutant NSCLC. Full data not yet available in peer-reviewed publication.
Conclusion: VIKTORIA-1 is evaluating gedatolisib plus fulvestrant with or without palbociclib in PIK3CA wild-type HR+/HER2- metastatic breast cancer post-CDK4/6 inhibitor. Full results pending peer-reviewed publication.
Primary endpoint: OS — Not significant (secondary endpoint)
Median PFS: NR (not significant) months
Median OS: 16.2 vs 14.2 months
Conclusion: Optune Pax plus gemcitabine and nab-paclitaxel significantly improved overall survival compared with chemotherapy alone in locally advanced pancreatic cancer.
Clinical impact: Regulatory
FDA status: Approved Feb 11, 2026 — locally advanced unresectable pancreatic adenocarcinoma
Intervention: Axicabtagene ciloleucel (anti-CD19 CAR-T) single infusion
Primary endpoint: Safety (TLT rate, G3+ AEs) — Not reported
Median PFS: Not reported months
Median OS: Not reported months
Conclusion: The FDA approved a label update for Yescarta removing the previous Limitations of Use for relapsed/refractory primary central nervous system lymphoma based on manageable safety profile with no new safety signals identified.
Clinical impact: Regulatory
FDA status: Label update Feb 6, 2026 — Limitations of Use removed for PCNSL
Conclusion: Daraxonrasib demonstrated encouraging antitumor activity as first-line therapy in RAS-mutant metastatic PDAC, both as monotherapy and in combination with gemcitabine/nab-paclitaxel, with manageable safety profiles.
Clinical impact: Early signal
FDA status: N/A — Phase 3 RASolute 302/303 ongoing
INFINITY (tremelimumab + durvalumab) — GI, Phase II
Presented at: AACR 2026
Population: Resectable MSI-H/dMMR gastric or gastroesophageal junction adenocarcinoma
Intervention: Tremelimumab 300 mg single dose + durvalumab 1500 mg Q4W (STRIDE regimen). Restaging at weeks 12-14. cCR patients → non-operative management with intense surveillance.
Primary endpoint: 2-yr cCR rate (cohort 2) — N/A
Median PFS: 2-yr PFS 94.1% months
Median OS: 2-yr OS 100% months
Conclusion: The STRIDE regimen of tremelimumab and durvalumab followed by non-operative management demonstrated promising feasibility in MSI-H resectable gastric/GEJ cancer, with 71% 2-year clinical complete response rate and 100% 2-year overall survival.
Conclusion: Elisrasib, a next-generation KRAS G12C inhibitor designed for faster and stronger target engagement, demonstrated promising response rates in patients with advanced NSCLC, including those whose disease progressed on prior first-generation KRAS G12C inhibitors.
Median OS: Not reached (responders) vs 3.4 yr (non-responders) months
Conclusion: In a phase 1 trial of a personalized mRNA neoantigen vaccine for pancreatic cancer, patients with vaccine-induced T-cell responses had significantly prolonged survival compared with non-responders, with 87.5% of responders alive at six years after surgery.
Clinical impact: Early signal
FDA status: N/A — Phase II randomized global trial underway
Conclusion: The FDA granted Priority Review to supplemental biologics license applications for KEYTRUDA and KEYTRUDA QLEX, each in combination with Padcev, for the treatment of patients with muscle-invasive bladder cancer who are eligible for cisplatin-based chemotherapy.
Clinical impact: Regulatory
FDA status: Pending — Priority Review granted Apr 20, 2026; PDUFA Aug 17, 2026
Conclusion: In a phase I/II study, trastuzumab and tucatinib combined with chemoradiation demonstrated promising activity in HER2-positive rectal adenocarcinoma, with 75% response rate and 50% clinical complete response rate, suggesting potential for non-operative management in selected patients.
TROPION-Breast02 (datopotamab deruxtecan) — Breast, Phase III
Population: Previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) for whom immunotherapy was not an option
Intervention: Datopotamab deruxtecan 6 mg/kg IV Q3W
Primary endpoint: PFS, OS (dual primary) — Not reported
Median PFS: 10.8 vs 5.6 months
Median OS: 23.7 vs 18.7 months
Conclusion: Datopotamab deruxtecan demonstrated significantly improved PFS and OS versus chemotherapy in patients with previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer for whom immunotherapy was not an option.
Clinical impact: Informative
FDA status: N/A — not yet approved for TNBC indication
ReDiscover (zovegalisib + atirmociclib + fulvestrant) — Breast, Phase II
Presented at: ASCO 2026
Population: HR+/HER2- metastatic breast cancer with PIK3CA mutation, progressed on prior CDK4/6 inhibitor + AI, 0-2 prior lines in mBC
Intervention: Zovegalisib 180 mg BID (3 weeks on, 1 week off) + atirmociclib 400 mg daily (continuous) + fulvestrant 500 mg IM D1,15 C1 then D1 Q28d
Primary endpoint: PFS vs external control — 53% (confirmed)
Median PFS: 11.0 (investigator) / 10.0 (BICR) months
Median OS: 24.9 months
Conclusion: The Phase 2 ReDiscover trial of zovegalisib, atirmociclib, and fulvestrant met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival versus external control in patients with PIK3CA-mutant HR-positive, HER2-negative metastatic breast cancer after progression on a CDK4/6 inhibitor and aromatase inhibitor.
Clinical impact: Early signal
FDA status: N/A — Phase 2 primary endpoint met; potential pivotal registration strategy being explored
Conclusion: The COMPANION-002 trial achieved its primary endpoint, demonstrating that tovecimig plus gemcitabine and cisplatin significantly improved progression-free survival compared with chemotherapy alone in first-line advanced biliary tract cancer, including a clinically meaningful benefit in the DLK1-positive subset.
Clinical impact: Early signal
FDA status: N/A — PFS met; OS missed due to crossover. Regulatory path under discussion.
Conclusion: NP137, a first-in-class NELL1-targeted therapy, demonstrated promising anti-tumor activity in metastatic pancreatic ductal adenocarcinoma and neuroendocrine tumors with a favorable safety profile, supporting further clinical development.
Intervention: Arm A: Pembro 400mg IV Q6W + Lenvatinib 20mg OD + Belzutifan 120mg OD
Arm B: MK-1308A (pembro 400mg + quavonlimab 25mg) IV Q6W + Lenvatinib 20mg OD
Primary endpoint: PFS (BICR), OS (dual primary) — Not reported
Median PFS: Not significant months
Median OS: Not significant months
Conclusion: The phase 3 LITESPARK-012 trial evaluating first-line pembrolizumab-based combination treatments for advanced renal cell carcinoma did not meet its dual primary endpoints of progression-free survival and overall survival at the prespecified interim analysis.
Clinical impact: Negative
FDA status: N/A — trial closed after failed interim analysis. Does not affect other LITESPARK trials (LITESPARK-011 sBLA pending for belzutifab+lenvatinib in pretreated RCC, PDUFA Oct 4, 2026).
Population: Relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), previously treated, ECOG PS 0-2
Intervention: Pirtobrutinib 200mg OD + Venetoclax + Rituximab (up to 2 years time-limited)
Primary endpoint: PFS (by ICR) — Not reported
Median PFS: Not disclosed (topline only) months
Median OS: Not mature (trending favorably) months
Conclusion: The addition of pirtobrutinib to venetoclax and rituximab led to a statistically significant and clinically meaningful improvement in progression-free survival compared with venetoclax and rituximab alone in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
Clinical impact: Informative
FDA status: N/A — Lilly intends to submit for label expansion later 2026
Population: Locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, progressed on/after platinum-based chemotherapy, with or without amivantamab
Conclusion: The FDA accepted a New Drug Application for zipalertinib for the treatment of patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy, with or without amivantamab.
Clinical impact: Regulatory
FDA status: Pending — NDA accepted Apr 28, 2026; PDUFA Feb 27, 2027; Breakthrough Therapy Designation 2021
Conclusion: The FDA granted Regenerative Medicine Advanced Therapy designation to Orca-Q for the treatment of high-risk hematologic malignancies, recognizing the significant unmet need and validating the promising clinical findings from the ongoing Phase 1 study.
Clinical impact: Early signal
FDA status: RMAT designation granted Apr 28, 2026 — accelerates development and review; eligible for priority/rolling reviews and accelerated approval pathways
Population: ER+/HER2- ESR1-mutated advanced or metastatic breast cancer after progression on ≥1 endocrine therapy
Intervention: Vepdegestrant 200mg IM Q4W (first 3 doses) then Q8W
Primary endpoint: PFS — 21.4% vs 8.9%
Median PFS: 11.2 vs 4.5 months
Median OS: NR vs 26.4 months
Conclusion: The FDA approved vepdegestrant, the first proteolysis-targeting chimera (PROTAC), for the treatment of adults with estrogen receptor-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer following progression on at least one line of endocrine therapy.
Clinical impact: Practice-changing
FDA status: Approved May 1, 2026 — ER+/HER2- ESR1-mutated advanced/metastatic BC post-endocrine therapy
Population: Adults with intermediate/high-risk myelofibrosis; adults with PV refractory/intolerant to hydroxyurea; adults/pediatric ≥12y with steroid-refractory acute or chronic GVHD
Intervention: Jakafi XR 55mg once daily (film-coated extended-release tablet)
Conclusion: The FDA approved Jakafi XR, a once-daily extended-release formulation of ruxolitinib, for the same indications as the original twice-daily Jakafi, providing a dosing option that may improve convenience for patients with myelofibrosis, polycythemia vera, and graft-versus-host disease.
Clinical impact: Informative
FDA status: Approved May 1, 2026 — once-daily XR formulation for MF, PV, GVHD (same indications as IR)
HERIZON-GEA-01 (zanidatamab + tislelizumab + chemotherapy) — GI, Phase III
Population: Previously untreated HER2-positive locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma
Intervention: Zanidatamab + tislelizumab + CAPOX or FP/XP chemotherapy
Primary endpoint: OS — 80.2% vs 70.6%
Median PFS: 12.2 vs 9.7 months
Median OS: 20.9 vs 17.1 months
Conclusion: The FDA accepted and granted Priority Review to the biologics license application for zanidatamab in combination with tislelizumab and chemotherapy for the first-line treatment of patients with HER2-positive gastric or gastroesophageal junction adenocarcinoma.
Clinical impact: Regulatory
FDA status: Pending — BLA accepted Apr 27, 2026; Priority Review; PDUFA Aug 25, 2026
Conclusion: The FDA Oncologic Drugs Advisory Committee voted 6 to 3 against recommending approval of camizestrant in combination with palbociclib for the treatment of patients with estrogen receptor-positive, HER2-negative advanced or metastatic breast cancer with ESR1 mutations following progression on a CDK4/6 inhibitor and aromatase inhibitor.
Clinical impact: Negative
FDA status: ODAC voted 6-3 AGAINST approval Apr 29, 2026 — FDA not bound by ODAC but usually follows. AstraZeneca continuing engagement.
Primary endpoint: rPFS — Improved (detailed at ASCO 2026)
Median PFS: Not disclosed (topline) months
Median OS: Immature (strong trend) months
Conclusion: In the phase 3 TALAPRO-3 trial, talazoparib plus enzalutamide demonstrated a statistically significant and clinically meaningful improvement in radiographic progression-free survival compared with placebo plus enzalutamide in patients with homologous recombination repair gene-mutated metastatic castration-sensitive prostate cancer.
Clinical impact: Practice-changing
FDA status: N/A — Pfizer engaging global health authorities for regulatory submission
Conclusion: Adjuvant selpercatinib demonstrated a statistically significant and clinically meaningful improvement in event-free survival compared with placebo in patients with resected stage II to IIIA RET fusion-positive non-small cell lung cancer.
Clinical impact: Practice-changing
FDA status: N/A — Lilly plans regulatory submission for adjuvant indication expansion
Population: HER2+ early-stage breast cancer (stage I-IIIA), clinically low-risk (ER+/HER2+ with low tumor burden; or ER-/HER2+ regardless of stage), 18-75 years
Intervention: Arm A: Trastuzumab 600mg SC Q3W + pertuzumab 840mg IV → 420mg IV Q3W + T-DM1 3.6mg/kg IV Q3W (chemo-free, 6 cycles) → HP maintenance
Arm B: Standard chemotherapy + HP (trastuzumab + pertuzumab) → HP maintenance
Conclusion: The PHERGain-2 trial demonstrated that a chemotherapy-free regimen of trastuzumab, pertuzumab, and trastuzumab emtansine achieved a pathological complete response rate of 59.6% in clinically low-risk HER2-positive early breast cancer, with lower toxicity and improved quality of life compared with standard chemotherapy plus trastuzumab and pertuzumab.
Clinical impact: Practice-changing
FDA status: N/A — Phase 2/3; DFS primary endpoint ongoing
Conclusion: In the DESTINY-Breast11 trial, trastuzumab deruxtecan-based neoadjuvant regimens achieved a residual cancer burden score of 0 or I in 81.3% of patients with high-risk operable HER2-positive early breast cancer, with higher rates observed in smaller tumors.
Clinical impact: Informative
FDA status: N/A — Phase 3 ongoing; iDFS primary endpoint not yet mature
Population: KRAS G12D-mutated pancreatic ductal adenocarcinoma (or other KRAS G12D-mutated solid tumors) with disease progression after all approved therapies
Intervention: Daraxonrasib monotherapy (dosing per treating physician discretion)
Primary endpoint: N/A — N/A
Conclusion: The FDA authorized an expanded access protocol for daraxonrasib for patients with KRAS G12D-mutated pancreatic ductal adenocarcinoma and other KRAS G12D-mutated solid tumors who have no satisfactory alternative treatment options.
Clinical impact: Regulatory
FDA status: EAP authorized May 1, 2026 — KRAS G12D-mutated PDAC and other solid tumors
Conclusion: In a phase 1-2 trial, daraxonrasib monotherapy demonstrated promising anti-tumor activity with a favorable safety profile in patients with previously treated KRAS G12D-mutated solid tumors, including pancreatic ductal adenocarcinoma, non-small cell lung cancer, and colorectal cancer.
Clinical impact: Informative
FDA status: N/A — Phase 3 RASolute 302 ongoing; EAP authorized May 2026
TRUST-I / TRUST-II (taletrectinib) — Lung, Phase II
Population: ROS1-positive metastatic NSCLC with disease progression after prior crizotinib therapy
Intervention: Taletrectinib 600mg OD
Primary endpoint: ORR, Safety — Not disclosed (post-crizotinib subset)
Median PFS: Not disclosed months
Median OS: Not disclosed months
Conclusion: The FDA accepted a supplemental New Drug Application for taletrectinib for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer who have disease progression after prior crizotinib therapy.
Clinical impact: Regulatory
FDA status: Pending — sNDA accepted May 5, 2026; PDUFA Jan 4, 2027
Conclusion: The phase 3 VIKTORIA-1 trial met its primary endpoint in the PIK3CA-mutated cohort, demonstrating that gedatolisib in combination with fulvestrant and palbociclib significantly improved progression-free survival compared with fulvestrant and palbociclib alone in patients with PIK3CA-mutated HR-positive, HER2-negative metastatic breast cancer following progression on a CDK4/6 inhibitor and aromatase inhibitor.
Clinical impact: Practice-changing
FDA status: N/A — Pfizer engaging regulatory authorities
ASTX727-07 (decitabine + cedazuridine + venetoclax) — Haematology, Phase II
Population: Newly diagnosed AML in adults ≥75 years or with comorbidities precluding intensive induction chemotherapy
Intervention: Decitabine 35mg + cedazuridine 100mg orally once daily on Days 1-5 of each 28-day cycle + venetoclax (5-day ramp-up: 20mg → 50mg → 100mg → 200mg → 400mg)
Primary endpoint: CR rate
Conclusion: The all-oral combination of decitabine and cedazuridine with venetoclax demonstrated a complete remission rate of 41.6% in adults with newly diagnosed acute myeloid leukemia who are 75 years or older or have comorbidities precluding intensive chemotherapy, providing the first fully outpatient HMA plus BCL-2 regimen for unfit patients.
Population: Adults with R/R MCL after ≥2 prior lines including anti-CD20 therapy and BTK inhibitor
Intervention: Sonrotoclax: 4-week ramp-up (80mg → 160mg → 240mg → 320mg target), then 320mg orally once daily with food until progression
Primary endpoint: ORR (IRC, Lugano)
Conclusion: Sonrotoclax demonstrated an objective response rate of 52% with a median duration of response of 15.8 months in adults with relapsed or refractory mantle cell lymphoma after at least 2 prior lines including a BTK inhibitor, providing the first BCL-2 inhibitor approved for this indication.
Population: Adults with advanced unresectable or metastatic NRG1 fusion-positive cholangiocarcinoma with progression on/after prior systemic therapy
Intervention: Zenocutuzumab 750mg IV infusion every 2 weeks (~4 hours) until progression
Primary endpoint: ORR (BICR, RECIST v1.1)
Conclusion: Zenocutuzumab demonstrated an objective response rate of 36.8% in adults with advanced NRG1 fusion-positive cholangiocarcinoma with disease progression on or after prior systemic therapy, expanding the approved indication for this NRG1-targeted bispecific antibody.
Clinical impact: Regulatory
FDA status: Approved May 2026 (7th CNPV; approved ~5 months early)
Intervention: Arm 1: Perioperative durvalumab + neoadjuvant EV → radical cystectomy → adjuvant durvalumab
Arm 2: Perioperative durvalumab + tremelimumab + neoadjuvant EV → radical cystectomy → adjuvant D+T
Primary endpoint: EFS + OS (dual primary)
Conclusion: Perioperative durvalumab plus neoadjuvant enfortumab vedotin demonstrated statistically significant and clinically meaningful improvements in both event-free survival and overall survival compared with standard of care in cisplatin-ineligible muscle-invasive bladder cancer.
MagnetisMM-5 (elranatamab) — Haematology, Phase III
Population: RRMM after ≥1 prior line including lenalidomide + proteasome inhibitor (double-class exposed)
Intervention: Arm A: Elranatamab SC monotherapy (recommended phase 2 dose)
Arm B: Elranatamab + daratumumab SC
Primary endpoint: PFS (BICR per IMWG)
Conclusion: Elranatamab monotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival versus daratumumab plus pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma after at least one prior line of therapy.
Clinical impact: Practice-changing
FDA status: Accelerated approval (4L+). Filing for full approval expected H2 2026; label expansion to ≥2L anticipated.
R3767-ONC-2011 (fianlimab + cemiplimab) — Skin, Phase III
Population: Previously untreated unresectable locally advanced or metastatic melanoma (Stage III/IV), age ≥12
Intervention: Arm A: Fianlimab 1600mg + cemiplimab 350mg Q3W (high-dose, n=508)
Arm B: Fianlimab 400mg + cemiplimab 350mg Q3W (low-dose, n=422)
Arm C: Cemiplimab 350mg monotherapy (n=154, reference arm)
Primary endpoint: PFS (BICR)
Conclusion: The fianlimab plus cemiplimab combination did not reach statistical significance for the primary endpoint of improved progression-free survival compared with pembrolizumab monotherapy in first-line unresectable or metastatic melanoma.
Clinical impact: Negative
FDA status: Not submitted (no BLA planned for this indication)
Population: Resected high-risk Stage IIB-IV cutaneous melanoma with lymph node metastasis; complete resection within 13 weeks; ECOG PS 0-1; no brain metastases
Intervention: Intismeran autogene 1mg IM every 3 weeks for 9 doses + pembrolizumab 200mg IV every 3 weeks for up to 18 cycles (~1 year)
Primary endpoint: RFS
Conclusion: Intismeran autogene in combination with pembrolizumab demonstrated a sustained and clinically meaningful improvement in recurrence-free survival at 5 years compared with pembrolizumab alone in patients with resected high-risk stage III/IV melanoma.
Clinical impact: Informative
FDA status: Breakthrough Therapy Designation (2023). Phase 3 INTerpath-001 enrolling.
TROPION-Breast02 (datopotamab deruxtecan) — Breast, Phase III
Population: Unresectable or metastatic TNBC not candidates for PD-1/PD-L1 inhibitor; no prior chemo for advanced disease; ECOG PS 0-1
Intervention: Datopotamab deruxtecan 6 mg/kg IV Q3W
Primary endpoint: PFS (BICR) + OS (co-primary)
Conclusion: The FDA approved datopotamab deruxtecan as the first TROP2-directed antibody drug conjugate for first-line treatment of patients with metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy, based on TROPION-Breast02 demonstrating median PFS of 10.8 vs 5.6 months and median OS of 23.7 vs 18.7 months versus chemotherapy.
Conclusion: The FDA approved trastuzumab deruxtecan for two separate indications in HER2-positive early-stage breast cancer: adjuvant treatment for patients with residual invasive disease after neoadjuvant therapy based on DESTINY-Breast05 showing 3-year IDFS of 92.4% vs 83.7%, and neoadjuvant T-DXd followed by THP based on DESTINY-Breast11 showing pCR of 67.3% vs 56.3%.
Population: Adults with R/R CLL after prior BCR inhibitor therapy
Intervention: Sonrotoclax oral per CLL3001 protocol until progression
Primary endpoint: ORR
Conclusion: The FDA granted accelerated approval to sonrotoclax for adults with relapsed or refractory chronic lymphocytic leukemia, with an overall response rate of approximately 85% in venetoclax-naive patients, representing the first next-generation BCL-2 inhibitor approved for this indication.
QUILT-3.032-Papillary (nogapendekin alfa inbakicept (N-803)) — GU, Phase III
Population: BCG-unresponsive NMIBC with papillary disease without CIS
Intervention: Nogapendekin alfa inbakicept 400 mcg intravesical + BCG
Primary endpoint: sBLA acceptance
Conclusion: The FDA accepted for priority review the supplemental Biologics License Application for ANKTIVA in combination with BCG for BCG-unresponsive non-muscle invasive bladder cancer with papillary disease without carcinoma in situ, with a PDUFA target action date of January 6, 2027.
Clinical impact: Regulatory
FDA status: sBLA accepted Priority Review — PDUFA Jan 6 2027
Conclusion: The NMPA approved the subcutaneous formulation of toripalimab as the first SC PD-1 antibody in China, demonstrating non-inferior pharmacokinetic exposure compared with the intravenous formulation with a 3-minute injection replacing a 60-minute infusion.
Intervention: Pembrolizumab 200mg IV Q3W + paclitaxel/carboplatin x12wk -> doxorubicin/cyclophosphamide x4 -> surgery -> adjuvant pembro x9 cycles
Primary endpoint: EFS + OS (co-primary EFS; secondary OS)
Conclusion: After a median follow-up of 7.8 years, neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab continues to show a clinically meaningful survival benefit with 7-year EFS of 78.3% vs 69.8% and 7-year OS of 85.1% vs 77.2% in patients with early-stage triple-negative breast cancer, with benefit observed across all subgroups.
Clinical impact: Practice-changing
FDA status: Approved (neoadjuvant + adjuvant pembro for Stage II-III TNBC)
Population: Advanced DDLS; any prior therapy; ECOG PS 0-2
Intervention: Abemaciclib 200mg orally BID until progression
Primary endpoint: PFS
Conclusion: Abemaciclib demonstrated a statistically significant improvement in progression-free survival compared with placebo in patients with advanced dedifferentiated liposarcoma, representing the first Phase 3 success of a CDK4/6 inhibitor in any sarcoma subtype.
Population: Localized or locally advanced high-risk PCa before and after radical prostatectomy; ECOG PS 0-1
Intervention: Apalutamide 240mg OD + ADT (LHRH agonist) perioperatively
Primary endpoint: pCR rate + MFS (co-primary)
Conclusion: Perioperative apalutamide plus androgen deprivation therapy demonstrated a statistically significant improvement in pathologic complete response rate compared with ADT alone in patients with high-risk localized prostate cancer undergoing radical prostatectomy, representing the first Phase 3 perioperative androgen receptor pathway inhibitor in this setting.
Intervention: Ivonescimab 20mg/kg IV Q3W + paclitaxel/carboplatin
Primary endpoint: PFS + OS (PFS met prior; OS at ASCO)
Conclusion: Ivonescimab plus chemotherapy demonstrated superior overall survival compared with tislelizumab plus chemotherapy in first-line advanced squamous non-small cell lung cancer, building on the previously reported progression-free survival benefit and representing the first bispecific PD-1 and VEGF inhibitor to demonstrate an OS advantage over PD-1 monotherapy in this setting.
Intervention: Selpercatinib 160mg BID (>=50kg) or 120mg BID (<50kg) until progression
Primary endpoint: EFS (investigator-assessed)
Conclusion: Adjuvant selpercatinib demonstrated a statistically significant and clinically meaningful improvement in event-free survival compared with placebo in patients with resected stage IB-IIIA RET fusion-positive non-small cell lung cancer, establishing the first adjuvant targeted therapy for this molecularly defined population.
Clinical impact: Practice-changing
FDA status: Approved (metastatic RET+ NSCLC); sNDA planned (adjuvant)
ASCENT-03 (sacituzumab govitecan + pembrolizumab) — Breast, Phase III
Presented at: ASCO 2026
Population: Previously untreated locally advanced inoperable or metastatic TNBC with PD-L1 CPS <10; ECOG PS 0-1
Intervention: Sacituzumab govitecan 10 mg/kg IV D1+D8 Q3W + pembrolizumab 200mg IV D1 Q3W
Primary endpoint: PFS
Conclusion: Sacituzumab govitecan in combination with pembrolizumab demonstrated a statistically significant improvement in progression-free survival compared with chemotherapy in patients with previously untreated PD-L1-negative metastatic triple-negative breast cancer, expanding the first-line treatment options for this patient population.
Intervention: 177Lu-PSMA-617 7.4 GBq IV Q6W x6 + enzalutamide 160mg OD OR abiraterone 1000mg OD + prednisone
Primary endpoint: rPFS + OS (co-primary)
Conclusion: 177Lu-PSMA-617 in combination with enzalutamide or abiraterone demonstrated a statistically significant improvement in radiographic progression-free survival compared with enzalutamide or abiraterone alone in patients with first-line PSMA-positive metastatic castration-sensitive prostate cancer, with an interim overall survival benefit also observed.
TroFuse-005 (sacituzumab tirumotecan) — Gynaecology, Phase III
Population: Advanced or recurrent endometrial carcinoma and carcinosarcoma; prior platinum-based chemo and anti-PD-1/PD-L1
Intervention: Sacituzumab tirumotecan 4 mg/kg IV D1 Q2W
Primary endpoint: OS + PFS (co-primary)
Conclusion: Sacituzumab tirumotecan demonstrated a statistically significant and clinically meaningful improvement in both overall survival and progression-free survival compared with treatment of physician choice in patients with advanced or recurrent endometrial cancer who had previously received platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy, representing the first TROP2 ADC to show an overall survival benefit in this setting.
Population: Previously treated metastatic PDAC; any RAS mutation status; progression after prior systemic therapy
Intervention: Daraxonrasib 300mg orally once daily
Primary endpoint: OS + PFS (co-primary)
Conclusion: Daraxonrasib demonstrated an unprecedented overall survival benefit in the phase 3 RASolute 302 trial, with a median overall survival of 13.2 months compared with 6.7 months for standard chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma, representing a 60% reduction in the risk of death across all RAS mutation types.
Clinical impact: Practice-changing
FDA status: Not submitted; NDA expected H2 2026; FDA EAP authorized Apr 30 2026
Intervention: Inavolisib orally + palbociclib 125mg OD D1-D21 Q4W + fulvestrant 500mg IM
Primary endpoint: PFS (dual co-primary endpoints)
Conclusion: Inavolisib in combination with palbociclib and fulvestrant demonstrated a statistically significant improvement in progression-free survival in patients with PIK3CA-mutant estrogen receptor-positive HER2-negative metastatic breast cancer after progression on a CDK4/6 inhibitor, with both co-primary PFS endpoints met in the phase 3 VIKTORIA-1 trial.
Clinical impact: Practice-changing
FDA status: Pending; FDA approval possible H1 2027
Conclusion: Neoadjuvant trastuzumab deruxtecan followed by THP demonstrated a significantly improved pathologic complete response rate of 67.3% compared with 56.3% for dose-dense doxorubicin and cyclophosphamide followed by THP, with 81.3% versus 69.1% achieving RCB-0 or RCB-I, representing the highest pCR rate in any phase 3 neoadjuvant HER2-positive early breast cancer trial.
Clinical impact: Practice-changing
FDA status: Approved May 2026 (neoadjuvant indication)
Population: Unresectable or metastatic conventional chondrosarcoma; no approved systemic therapy; ECOG PS 0-1
Intervention: Ozekibart (INBRX-109) IV per protocol until progression
Primary endpoint: ORR + DCR
Conclusion: Ozekibart demonstrated an objective response rate of 48% and a disease control rate of 96% in patients with advanced conventional chondrosarcoma, an orphan disease with no previously approved systemic therapy, representing the first proof-of-concept for a DR5 agonist antibody in this setting.
Population: Relapsed or refractory blastic plasmacytoid dendritic cell neoplasm after at least one prior systemic therapy
Intervention: Pivekimab sunirine IV per protocol until progression
Primary endpoint: ORR
Conclusion: The FDA granted accelerated approval to pivekimab sunirine for patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm who have received at least one prior systemic therapy, based on the AURIGA trial demonstrating an objective response rate of 80%.
Population: BCG-naive high-risk NMIBC (T1, Grade 3, CIS, or multiple/recurrent/large tumors) following TURBT
Intervention: Durvalumab 1500mg IV Q4W x13 cycles + BCG induction and maintenance
Primary endpoint: DFS (investigator-assessed)
Conclusion: The FDA approved durvalumab in combination with BCG as the first new therapy in over 30 years for patients with BCG-naive high-risk non-muscle invasive bladder cancer, based on the POTOMAC trial demonstrating a statistically significant improvement in disease-free survival with a hazard ratio of 0.68 compared with BCG alone.
Conclusion: The FDA accepted for priority review the New Drug Application for giredestrant for patients with estrogen receptor-positive HER2-negative advanced breast cancer following progression on a CDK4/6 inhibitor and an aromatase inhibitor, based on the perseverAV trial demonstrating median progression-free survival of 9.5 versus 6.9 months and median overall survival of 37.9 versus 31.7 months, with a PDUFA target action date of August 25, 2026.
Clinical impact: Regulatory
FDA status: NDA accepted with Priority Review — PDUFA Aug 25 2026
Population: Ph+ CML in chronic phase or accelerated phase; adults and paediatric patients >=1 year; newly diagnosed or resistant/intolerant to prior TKI
Conclusion: The FDA approved nilotinib orally disintegrating tablets for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia in both adult and paediatric patients one year of age and older, providing the first orally disintegrating formulation of nilotinib with comparable efficacy and safety to the capsule formulation and improved palatability for paediatric patients.
C-144-01 (lifileucel (TIL therapy)) — Skin, Phase II
Population: Unresectable or metastatic melanoma in adults >=18 years; progressed on or after anti-PD-1 therapy; no prior TIL therapy
Intervention: Autologous TIL product: tumour tissue harvest -> ex vivo TIL expansion -> lymphodepletion -> single infusion of lifileucel -> IL-2 support
Primary endpoint: ORR
Conclusion: Lifileucel was approved in Australia for the treatment of unresectable or metastatic melanoma in adults who have progressed on or after anti-PD-1 therapy, based on the C-144-01 trial demonstrating an objective response rate of 31.4% with durable ongoing responses and a manageable safety profile.
Population: KRAS G12D mutant NSCLC; 2nd-line or greater; progressed on or after platinum-based chemotherapy and immunotherapy
Intervention: VS-7375 oral (dose escalation 50mg to 600mg; RP2D >=200mg)
Primary endpoint: ORR
Conclusion: The FDA granted Fast Track Designation to VS-7375 for the treatment of KRAS G12D mutant non-small cell lung cancer in the second-line or greater setting, based on the RAMP 203 trial demonstrating objective response rates of 46.3% across all doses and up to 62.5% at higher dose levels, with a median duration of response of 12.8 months.
Clinical impact: Regulatory
FDA status: Fast Track Designation Jun 2026 (KRAS G12D NSCLC 2L+)
Population: Previously untreated metastatic NSCLC with PD-L1 TPS <1%; no actionable driver mutations; ECOG PS 0-1
Intervention: Sacituzumab govitecan 10 mg/kg IV D1+D8 Q3W + pembrolizumab 200mg IV D1 Q3W
Primary endpoint: OS
Conclusion: Sacituzumab govitecan in combination with pembrolizumab did not demonstrate an improvement in overall survival compared with pembrolizumab monotherapy in patients with previously untreated PD-L1-negative metastatic non-small cell lung cancer, leading to the premature halt of the EVOKE-03 trial at interim futility analysis.
Clinical impact: Negative
FDA status: Not submitted (futility); Trodelvy label already removed PD-L1 neg NSCLC Dec 2024
Population: First-line BRAF V600E mutant metastatic colorectal cancer; ECOG PS 0-2; no prior systemic therapy for mCRC
Intervention: Encorafenib 300mg orally OD + cetuximab 400mg/m2 IV loading then 250mg/m2 IV QW + FOLFIRI Q2W
Primary endpoint: ORR + PFS (co-primary)
Conclusion: Encorafenib in combination with cetuximab and FOLFIRI demonstrated a significantly improved objective response rate of 70% compared with 34% for standard-of-care chemotherapy in patients with first-line BRAF V600E mutant metastatic colorectal cancer, with consistent efficacy observed even in patients with poor performance status.
Clinical impact: Practice-changing
FDA status: Pending (sNDA expected for 1L BRAF V600E mCRC)
Population: First-line advanced RET fusion-positive NSCLC; ECOG PS 0-1; no prior systemic therapy
Intervention: Pralsetinib 400mg orally once daily until progression
Primary endpoint: PFS + OS (co-primary PFS; secondary OS)
Conclusion: Pralsetinib demonstrated a statistically significant improvement in progression-free survival with a median PFS of 19.5 versus 7.7 months compared with chemotherapy plus pembrolizumab in patients with first-line RET fusion-positive advanced non-small cell lung cancer, with an overall survival hazard ratio of 0.62 favouring pralsetinib and a disease control rate of 97.8%.
Clinical impact: Practice-changing
FDA status: Pending (confirmatory Phase 3 for FDA full approval)
Population: Intermediate- to high-risk localized prostate cancer (NCCN criteria); ECOG PS 0-2; planned definitive external beam radiotherapy
Intervention: Aglatimagene besadenovec intraprostatic injection x3 + valacyclovir orally + standard-of-care EBRT (with or without short-term ADT)
Primary endpoint: DFS
Conclusion: Aglatimagene besadenovec plus valacyclovir in combination with standard-of-care radiotherapy significantly improved disease-free survival compared with radiotherapy alone in patients with intermediate- to high-risk localized prostate cancer, with a hazard ratio of 0.70, a prostate cancer-specific disease-free survival hazard ratio of 0.61, and an 80.4% versus 63.6% pathological complete response rate at two-year biopsy, representing the first positive multicenter phase 3 trial in this setting in over 20 years.
Clinical impact: Practice-changing
FDA status: Not submitted; BLA submission planned Q4 2026
Population: Completely resected stage IB-IIIA RET fusion-positive NSCLC
Intervention: Adjuvant selpercatinib 160mg orally BID (>=50kg) or 120mg BID (<50kg) for up to 2 years
Primary endpoint: N/A (guideline update)
Conclusion: The NCCN NSCLC Guidelines version 4.2026 and ASCO living guidelines now recommend adjuvant selpercatinib for patients with completely resected RET fusion-positive stage IB-IIIA non-small cell lung cancer, based on the LIBRETTO-432 trial demonstrating a hazard ratio of 0.17 for event-free survival.
CAPItello-281 (capivasertib + abiraterone + prednisone) — GU, Phase III
Population: Newly diagnosed PTEN-deficient mAPMN/S prostate cancer; ECOG PS 0-1; no prior androgen pathway modulation for advanced disease
Intervention: Capivasertib 400mg orally BID 4 days on / 3 days off + abiraterone 1000mg OD + prednisone 5mg OD + GnRH analog
Primary endpoint: rPFS (investigator-assessed)
Conclusion: The FDA approved capivasertib in combination with abiraterone and prednisone for the treatment of adults with PTEN-deficient metastatic androgen pathway modulation-naive or sensitive prostate cancer, based on the CAPItello-281 trial demonstrating a median radiographic progression-free survival of 33.2 versus 25.7 months, representing the first targeted therapy and first AKT inhibitor approved for this indication.
Population: HR+/HER2+ locally advanced or metastatic breast cancer; no disease progression after induction with taxane + trastuzumab +/- pertuzumab; ECOG PS 0-1
Intervention: Palbociclib 125mg orally OD D1-D21 Q4W + trastuzumab +/- pertuzumab + fulvestrant or AI (anastrozole, letrozole, or exemestane)
Conclusion: The FDA approved palbociclib in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with hormone receptor-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment, based on the PATINA trial demonstrating a median progression-free survival of 44.3 versus 29.1 months, representing the first CDK4/6 inhibitor approved for this patient population.
Precision-T (allogeneic regulatory T cell immunotherapy + HSPC + T cells-vldq) — Haematology, Phase III
Population: Adults with AML, ALL, or MDS undergoing matched donor allo-HSCT with myeloablative preparative regimen; ECOG PS 0-2; 8/8 HLA-matched related or unrelated donor
Intervention: Tregzi: HSPC >=1.0x10^6 cells/kg IV day 0 -> Tregs 1.3-3.5x10^6 cells/kg IV day 0 -> Tcons 1.3-6.9x10^6 cells/kg IV day +2 to +3
Primary endpoint: cGVHD-free survival (primary)
Conclusion: The FDA approved Tregzi, the first regulatory T cell-based immunotherapy, for use in matched donor hematopoietic stem cell transplantation to improve chronic graft-versus-host disease-free survival in adults with hematologic malignancies, based on the Precision-T trial demonstrating a one-year chronic GVHD-free survival rate of 78% compared with 38% for standard transplant.
Population: Unresectable or metastatic TNBC; no prior systemic therapy for advanced disease; ECOG PS 0-1
Intervention: Sacituzumab govitecan 10 mg/kg IV D1+D8 Q3W + pembrolizumab 200mg IV D1 Q3W
Primary endpoint: PFS (BICR)
Conclusion: The FDA approved sacituzumab govitecan in combination with pembrolizumab for the first-line treatment of patients with unresectable or metastatic triple-negative breast cancer, regardless of PD-L1 expression status, based on the ASCENT-04 trial in PD-L1-positive patients showing a progression-free survival hazard ratio of 0.70 and the ASCENT-03 trial in PD-L1-negative patients showing a hazard ratio of 0.64.
Clinical impact: Practice-changing
FDA status: Approved Jun 2026 (1L mTNBC, all PD-L1 statuses)
Intervention: Alectinib 600mg orally BID for 2 years or until recurrence/progression
Primary endpoint: DFS (disease-free survival)
Conclusion: The FDA granted traditional approval to alectinib for the adjuvant treatment of patients with completely resected ALK-positive stage IB-IIIA non-small cell lung cancer, based on the ALINA trial demonstrating a disease-free survival hazard ratio of 0.24 with two-year and three-year disease-free survival rates of 93.8% versus 63.0% and 88.3% versus 53.8%, respectively, representing the first ALK inhibitor approved in the adjuvant setting.
Clinical impact: Practice-changing
FDA status: Approved Jun 2026 (traditional approval with mature DFS)
Conclusion: The FDA approved Jakafi XR, an extended-release formulation of ruxolitinib for once-daily administration, providing equivalent efficacy and safety to the twice-daily immediate-release formulation for patients with intermediate or high-risk myelofibrosis, polycythemia vera, and steroid-refractory graft-versus-host disease.
Clinical impact: Regulatory
FDA status: Approved Jun 2026 (Jakafi XR extended-release)
Population: Advanced GIST after progression on imatinib; KIT mutation-positive; ECOG PS 0-2
Intervention: Bezuclastinib + sunitinib 37.5mg orally OD
Primary endpoint: PFS
Conclusion: Bezuclastinib in combination with sunitinib demonstrated a statistically significant improvement in progression-free survival with a median of 8.4 versus 3.5 months compared with sunitinib alone in patients with advanced gastrointestinal stromal tumors after progression on imatinib, representing the first positive phase 3 trial for a CTA inhibitor in GIST.
Clinical impact: Practice-changing
FDA status: NDA accepted with Priority Review — PDUFA Oct 24 2026
frontMIND (tafasitamab + lenalidomide + R-CHOP) — Haematology, Phase III
Presented at: ASCO 2026 / EHA 2026
Population: Newly diagnosed high-intermediate or high-risk DLBCL or HGBCL by IPI; ECOG PS 0-2; eligible for R-CHOP
Intervention: Tafasitamab 12 mg/kg IV D1-4 C1-3 then D1-2 C4-6 + lenalidomide 25mg orally D1-14 + R-CHOP Q3W x6 cycles
Primary endpoint: PFS (investigator-assessed)
Conclusion: Tafasitamab in combination with lenalidomide and R-CHOP demonstrated a statistically significant improvement in progression-free survival compared with R-CHOP alone in patients with newly diagnosed high-risk diffuse large B-cell lymphoma, with a two-year progression-free survival rate of 71.1% versus 62.9% and a 25% reduction in the risk of disease progression or death.
Conclusion: Teclistamab in combination with daratumumab, pomalidomide, and dexamethasone demonstrated a statistically significant improvement in progression-free survival compared with daratumumab, pomalidomide, and dexamethasone alone in patients with relapsed or refractory multiple myeloma, representing the first phase 3 trial to demonstrate a progression-free survival benefit for a BCMA bispecific antibody-containing triplet regimen.
Conclusion: Epcoritamab in combination with lenalidomide demonstrated a statistically significant improvement in overall survival compared with investigator choice chemotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma, representing the first bispecific antibody and immunomodulatory drug combination to demonstrate an overall survival benefit in this setting.
Conclusion: Atezolizumab in combination with FOLFOX demonstrated a statistically significant improvement in disease-free survival with a hazard ratio of 0.54 compared with FOLFOX alone in patients with stage III deficient mismatch repair colon cancer following complete resection, establishing the first PD-L1 inhibitor to demonstrate a disease-free survival benefit in the adjuvant setting for this molecularly defined population.
Clinical impact: Practice-changing
FDA status: sBLA accepted with Priority Review (Jun 10-11 2026)
Population: First-line advanced or metastatic NSCLC; no actionable driver mutations; any PD-L1 expression status
Intervention: Retifanlimab + platinum-based chemotherapy as Category 1 recommendation
Primary endpoint: N/A (guideline update)
Conclusion: The ASCO Living Guideline for non-small cell lung cancer version 2026.3.1 now recommends retifanlimab in combination with platinum-based chemotherapy as a Category 1 treatment option for first-line advanced or metastatic NSCLC regardless of PD-L1 expression status, based on the POD1UM-204 trial demonstrating a progression-free survival hazard ratio of 0.66 and an overall survival hazard ratio of 0.72.
Population: Stage III dMMR colon cancer post-complete resection; adjuvant setting
Intervention: Atezolizumab + FOLFOX as Category 1 recommendation for adjuvant stage III dMMR colon cancer
Primary endpoint: N/A (guideline update)
Conclusion: The NCCN Colon Cancer Guidelines version 3.2026 and ASCO living guidelines now recommend atezolizumab in combination with FOLFOX as a Category 1 treatment option for adjuvant treatment of patients with stage III deficient mismatch repair colon cancer following complete resection, based on the ATOMIC trial demonstrating a disease-free survival hazard ratio of 0.54.
IRAKLIA (isatuximab-irfc (subcutaneous)) — Haematology, Phase III
Population: Multiple myeloma (all approved IV indications)
Intervention: Isatuximab-irfc subcutaneous via CirCLIQ on-body injector (OBI) or manual SC injection, in combination with standard-of-care regimens (pomalidomide+dexamethasone, carfilzomib+dexamethasone, or bortezomib+lenalidomide+dexamethasone)
Primary endpoint: ORR (non-inferiority)
Conclusion: The FDA approved subcutaneous Sarclisa Escena (isatuximab-irfc) as the first anticancer treatment to be administered through both an on-body injector and manual subcutaneous administration, for the treatment of patients with multiple myeloma across all existing indications of the intravenous formulation, based on data from the pivotal IRAKLIA phase 3 non-inferiority study demonstrating comparable efficacy, pharmacokinetics and safety with significantly shorter treatment time and fewer infusion-related reactions.
Population: Previously treated KRAS G12C-mutant advanced or metastatic NSCLC; progressed on prior platinum-based chemotherapy
Intervention: Divarasib once daily orally (monotherapy)
Primary endpoint: PFS (BICR-assessed)
Conclusion: Divarasib showed clinically meaningful and statistically significant improvements in both progression-free survival and overall survival compared with approved first-generation KRAS G12C inhibitors in previously treated KRAS G12C-mutant NSCLC, with no new safety signals, establishing its potential as a new standard of care for this patient population.
MANGROVE (zanubrutinib + rituximab) — Haematology, Phase III
Population: Previously untreated mantle cell lymphoma; age >=70 OR age >=60 with comorbidities precluding ASCT; ECOG PS 0-2; no prior systemic therapy for MCL
Intervention: Zanubrutinib 160mg orally twice daily + rituximab during initial treatment period, followed by zanubrutinib monotherapy until disease progression or intolerance
Primary endpoint: PFS (IRC-assessed)
Conclusion: Zanubrutinib plus rituximab demonstrated a statistically significant and clinically meaningful improvement in PFS versus bendamustine plus rituximab in previously untreated mantle cell lymphoma, with a 43% reduction in the risk of progression or death and no new safety signals, representing the first Phase 3 global randomized trial to evaluate a chemotherapy-free BTK inhibitor-based regimen against standard chemoimmunotherapy in frontline MCL.
Conclusion: NCCN Breast Cancer Guidelines Version 4.2026 provide an updated framework for metastatic breast cancer management, with major shifts including: sacituzumab govitecan plus pembrolizumab as category 1 preferred for PD-L1+ 1L TNBC (ADC-IO combination displacing chemotherapy); THP remaining preferred over T-DXd plus pertuzumab in 1L HER2+ despite superior PFS due to ILD/mortality signal; palbociclib addition to maintenance in HR+/HER2+ disease after induction (PATINA: mPFS 44 vs 29 months, HR 0.75); vepdegestrant added for ESR1-mutant HR+ disease; and expanded biomarker-directed sequencing across all subtypes.
VIKTORIA-1 (gedatolisib + fulvestrant ± palbociclib) — Breast, Phase III
Population: HR+/HER2- locally advanced or metastatic breast cancer, PIK3CA wild-type, after ≥1 line endocrine therapy in metastatic setting
Intervention: Gedatolisib (pan-PI3K/AKT/mTOR inhibitor) + fulvestrant 500mg IM D1, 15, 29 then Q4W ± palbociclib 125mg orally D1-21 Q4W
Primary endpoint: PFS (BICR)
Conclusion: The FDA approved gedatolisib (Revtorpyk) in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting, based on the VIKTORIA-1 Phase 3 trial demonstrating median PFS of 9.3 months for the triplet and 7.4 months for the doublet versus 2.0 months for control.
Population: Locally advanced or metastatic ROS1-positive NSCLC who received at least one prior ROS1 TKI (including lorlatinib, repotrectinib, taletrectinib)
Intervention: Zidesamtinib 100mg orally once daily, with or without food, until progression or unacceptable toxicity
Primary endpoint: ORR + DOR (BICR)
Conclusion: The FDA approved zidesamtinib (Jideytro) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer who received at least one prior ROS1 tyrosine kinase inhibitor, based on the ARROS-1 single-arm trial showing an overall response rate of 44% with 82% of responders maintaining response for at least 6 months and 69% for at least 12 months, including activity in patients with measurable brain metastases.
PSMAddition (lutetium Lu 177 vipivotide tetraxetan + ARPI) — Prostate, Phase III
Population: PSMA-positive metastatic androgen pathway modulation-naive or -sensitive (mAPMN/S) prostate cancer; selected by PSMA PET imaging
Intervention: Lutetium Lu 177 vipivotide tetraxetan 7.4 GBq (200 mCi) IV every 6 weeks for 6 doses + ARPI (abiraterone, apalutamide, enzalutamide, or darolutamide per investigator choice) + GnRH agonist/antagonist or bilateral orchiectomy
Primary endpoint: rPFS (BICR)
Conclusion: The FDA approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto) in combination with androgen receptor pathway inhibitor therapy for adults with PSMA-positive metastatic androgen pathway modulation-naive or -sensitive prostate cancer, based on the PSMAddition Phase 3 trial demonstrating a statistically significant improvement in radiographic progression-free survival with a hazard ratio of 0.72 and p-value of 0.002, representing the first PSMA-targeted radioligand therapy approved in the hormone-sensitive setting.
Population: Unresectable advanced cutaneous melanoma (Stage IIIB, IIIC or IV) with disease progression on ≥8 consecutive weeks of prior anti-PD-1-based therapy
Intervention: Vusolimogene oderparepvec-wtpg 1 mL/cm of largest tumor dimension (max 10 mL total) intratumoral injection every 2 weeks for 8 doses; Week 1: 10^6 PFU/mL, subsequent: 10^7 PFU/mL. Nivolumab IV starting Week 3 per prescribing info.
Primary endpoint: ORR + DOR
Conclusion: The FDA granted accelerated approval to vusolimogene oderparepvec-wtpg (Tudriqev) in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression on a programmed death receptor-1-blocking antibody-based regimen, based on the IGNYTE trial showing an objective response rate of 24.2% and a median duration of response of 14.1 months, with continued approval contingent upon verification of clinical benefit in the confirmatory IGNYTE-3 trial.
Population: Relapsed or refractory multiple myeloma after ≥1 prior line including proteasome inhibitor and immunomodulatory agent; excluded if refractory to prior anti-CD38 mAb or bortezomib
Conclusion: The FDA granted accelerated approval to iberdomide (Zenbexus) in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent, based on the EXCALIBER-RRMM Phase 3 trial demonstrating a minimal residual disease-negative complete response rate of 41% versus 21% with the comparator, marking the first FDA-approved CELMoD therapy and the first relapsed/refractory multiple myeloma approval based on MRD-negative complete response.
Population: HER2-positive (IHC 3+ or 2+) advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, untreated in metastatic setting
Intervention: Zanidatamab 20 mg/kg IV Q2W + FOLFOX (oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + 5-FU 400 mg/m2 bolus then 2400 mg/m2 over 46h) Q2W ± tislelizumab
Primary endpoint: PFS (BICR)
Conclusion: The FDA approved zanidatamab in combination with fluoropyrimidine- and platinum-based chemotherapy, with or without tislelizumab, for the first-line treatment of adults with HER2-positive (IHC 3+ or 2+) advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, based on the HERIZON-GEA-01 Phase 3 trial demonstrating a statistically significant improvement in progression-free survival with a hazard ratio of 0.63 and median PFS of 12.8 versus 9.8 months.
Population: KRAS G12C-mutated metastatic pancreatic adenocarcinoma, previously treated with at least one systemic therapy
Intervention: Daraxonrasib orally once daily (dose per prescribing information)
Primary endpoint: OS
Conclusion: The FDA approved daraxonrasib for adults with KRAS G12C-mutated metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy, based on the RASolute 302 Phase 3 trial demonstrating a statistically significant improvement in overall survival with a median of 8.3 versus 4.7 months, representing the first FDA-approved targeted therapy for this molecular subset of pancreatic cancer.
Conclusion: The FDA approved ropeginterferon alfa-2b for the treatment of adults with essential thrombocythemia who have had prior treatment failure or intolerance to hydroxyurea, based on the SURPASS-ET Phase 3 trial demonstrating a complete hematologic response rate of 58% versus 20% with best available therapy and providing the first interferon-based treatment option specifically approved for this indication.
Intervention: Adagrasib 600 mg orally twice daily + cetuximab per standard dosing (indication withdrawn Sep 2026)
Primary endpoint: PFS
Conclusion: The FDA withdrew the accelerated approval indication for adagrasib in combination with cetuximab for the treatment of adults with previously treated KRAS G12C-mutated metastatic colorectal cancer, effective September 1, 2026, because the confirmatory KRYSTAL-10 Phase 3 trial did not verify clinical benefit, representing the first regulatory withdrawal of a KRAS G12C inhibitor combination in colorectal cancer.
SERENA-6 (camizestrant + palbociclib (or other CDK4/6i)) — Breast, Phase III
Population: ESR1-mutant HR+/HER2- advanced or metastatic breast cancer, progression on prior endocrine therapy + CDK4/6 inhibitor
Intervention: Camizestrant orally once daily + palbociclib 125 mg orally D1-21 Q4W (or other approved CDK4/6 inhibitor per label)
Primary endpoint: PFS (BICR)
Conclusion: The FDA granted accelerated approval to camizestrant in combination with a CDK4/6 inhibitor for adults with ESR1-mutant hormone receptor-positive, HER2-negative advanced or metastatic breast cancer who have progressed on prior endocrine therapy, based on the SERENA-6 Phase 3 trial demonstrating a median progression-free survival of 9.2 versus 3.8 months with a hazard ratio of 0.49, representing the first FDA-approved next-generation selective estrogen receptor degrader for this molecular subset.
Population: HER2 exon 20 insertion mutation-positive locally advanced or metastatic NSCLC, previously treated with platinum-based chemotherapy
Intervention: Sevabertinib orally once daily (dose per prescribing information) until progression or unacceptable toxicity
Primary endpoint: ORR (BICR)
Conclusion: The FDA granted accelerated approval to sevabertinib for adults with HER2 exon 20 insertion mutation-positive locally advanced or metastatic non-small cell lung cancer who have received prior platinum-based chemotherapy, based on the SOHO-01 Phase 2 trial demonstrating an objective response rate of 58% and a median duration of response of 12.5 months, representing the first FDA-approved therapy specifically for this molecular subset of NSCLC.
TRUST-I / TRUST-II (taletrectinib) — Lung, Phase II
Population: ROS1-positive locally advanced or metastatic NSCLC, both TKI-naive and TKI-pretreated
Intervention: Taletrectinib 600 mg orally once daily (TKI-naive) or 400 mg (TKI-pretreated) until progression or unacceptable toxicity
Primary endpoint: ORR + DOR
Conclusion: The FDA expanded the approval of taletrectinib to include both TKI-naive and TKI-pretreated ROS1-positive locally advanced or metastatic non-small cell lung cancer, based on updated pooled analysis from the TRUST-I and TRUST-II trials demonstrating an objective response rate of 88% in TKI-naive patients with a median duration of response not reached, and 51% in TKI-pretreated patients with a median duration of response of 9.2 months.
Conclusion: The FDA approved imlunestrant in combination with abemaciclib for adults with ESR1-mutant hormone receptor-positive, HER2-negative advanced or metastatic breast cancer who have progressed on prior endocrine therapy, based on the EMBER-3 Phase 3 trial demonstrating a median progression-free survival of 9.4 versus 3.7 months with a hazard ratio of 0.52, marking the first approval of a complete estrogen receptor antagonist in combination with a CDK4/6 inhibitor for this indication.
DESTINY-Lung04 (trastuzumab deruxtecan) — Lung, Phase III
Presented at: WCLC 2026
Population: HER2-mutant (exon 20 insertion or point mutation) advanced or metastatic NSCLC, treatment-naive in metastatic setting, no prior HER2-directed therapy
Intervention: Trastuzumab deruxtecan 5.4 mg/kg IV Q3W
Primary endpoint: PFS (BICR)
Conclusion: Trastuzumab deruxtecan demonstrated a statistically significant improvement in progression-free survival compared with pembrolizumab plus chemotherapy in treatment-naive HER2-mutant advanced non-small cell lung cancer, with a hazard ratio of 0.62 and median PFS of 11.2 versus 6.8 months, though overall survival data remain immature with an early hazard ratio of 1.15 raising caution, and interstitial lung disease or pneumonitis occurred in 14% of patients including two treatment-related deaths.
Conclusion: Zipalertinib in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared with chemotherapy alone in treatment-naive EGFR exon 20 insertion mutation-positive advanced non-small cell lung cancer, with a hazard ratio of 0.48 and median PFS of 9.5 versus 5.3 months, supporting the use of this combination as a new standard of care for this molecular subset.
Clinical impact: Practice-changing
FDA status: Approved (zipalertinib monotherapy Mar 2026; combo approval pending)
TAISHAN-302 (tambotatug pelitecan) — Lung, Phase III
Presented at: WCLC 2026
Population: Relapsed or refractory small cell lung cancer, progressed on or after platinum-based chemotherapy
Intervention: Tambotatug pelitecan IV Q3W (dose per protocol)
Primary endpoint: OS
Conclusion: Tambotatug pelitecan demonstrated a statistically significant improvement in overall survival compared with topotecan in relapsed small cell lung cancer, with a median of 9.2 versus 6.1 months and a hazard ratio of 0.68, representing the first positive Phase 3 trial of a B7-H3-targeted antibody-drug conjugate in this disease and establishing a new treatment option for patients who have progressed after platinum-based chemotherapy.
ARTEMIS-008 (risvutatug rezetecan) — Lung, Phase III
Presented at: WCLC 2026
Population: Relapsed or refractory small cell lung cancer, progressed on or after platinum-based chemotherapy
Intervention: Risvutatug rezetecan IV Q3W (dose per protocol)
Primary endpoint: OS
Conclusion: Risvutatug rezetecan demonstrated a statistically significant improvement in overall survival compared with topotecan in relapsed small cell lung cancer, with a median of 8.7 versus 5.8 months and a hazard ratio of 0.71, representing the second positive Phase 3 trial of a B7-H3-targeted antibody-drug conjugate in this setting and further validating B7-H3 as a therapeutic target in small cell lung cancer.
Population: PD-L1-positive (TPS >=1%) locally advanced or metastatic NSCLC, treatment-naive, no driver mutations
Intervention: Ivonescimab 20 mg/kg IV Q3W
Primary endpoint: OS
Conclusion: Ivonescimab demonstrated a statistically significant improvement in overall survival compared with pembrolizumab in first-line PD-L1-positive non-small cell lung cancer, with a hazard ratio of 0.63 and median overall survival not reached versus 21.3 months, supporting the use of this PD-1/VEGF bispecific antibody as a potential new standard of care in this setting, with confirmatory global Phase 3 trials ongoing.
Population: PD-L1-high (TPS >=50%) metastatic NSCLC, treatment-naive, no driver mutations
Intervention: Sacituzumab govitecan 10 mg/kg IV D1, 8 Q3W + pembrolizumab 200 mg IV Q3W
Primary endpoint: PFS (BICR)
Conclusion: Sacituzumab govitecan in combination with pembrolizumab did not demonstrate an improvement in progression-free survival compared with pembrolizumab monotherapy in first-line PD-L1-high metastatic non-small cell lung cancer, with a median PFS of 6.8 versus 7.4 months and a hazard ratio of 1.12, representing a negative Phase 3 trial that does not support the addition of this antibody-drug conjugate to frontline immunotherapy in this population.
PAPILLON (amivantamab + chemotherapy) — Lung, Phase III
Presented at: WCLC 2026
Population: EGFR exon 20 insertion mutation-positive locally advanced or metastatic NSCLC, treatment-naive in metastatic setting
Intervention: Amivantamab 1050 mg IV (<80kg) or 1400 mg (>=80kg) Q2W + carboplatin AUC5 + pemetrexed 500 mg/m2 Q3W x4 cycles then amivantamab + pemetrexed maintenance
Primary endpoint: OS (final analysis)
Conclusion: The final overall survival analysis of the PAPILLON Phase 3 trial did not demonstrate a statistically significant improvement in overall survival with amivantamab plus chemotherapy compared with chemotherapy alone in EGFR exon 20 insertion mutation-positive advanced non-small cell lung cancer, with a median of 28.2 versus 24.5 months and a hazard ratio of 0.82, though the previously reported progression-free survival benefit remains the basis for the use of this combination as standard of care in this population.
MAVERICK / SWOG S1827 (MRI surveillance vs PCI) — Lung, Phase III
Presented at: WCLC 2026
Population: Limited-stage small cell lung cancer, complete or partial response after chemoradiation, no brain metastases at baseline
Intervention: MRI surveillance every 3 months for 2 years then every 6 months
Primary endpoint: Cognitive function (HVLT-R delayed recall at 6 mo)
Conclusion: MRI surveillance alone demonstrated non-inferior cognitive outcomes compared with prophylactic cranial irradiation plus MRI surveillance in patients with limited-stage small cell lung cancer who had responded to initial chemoradiation, with a mean decline in Hopkins Verbal Learning Test-Revised delayed recall of 0.8 versus 3.2 points at 6 months, supporting MRI surveillance as an alternative to PCI for preserving cognitive function in this population.
INTerpath-001 (intismeran autogene + pembrolizumab) — Skin, Phase III
Presented at: ASCO 2026
Population: Resected stage III/IV melanoma (AJCC 8th edition), high risk of recurrence, ECOG PS 0-1
Intervention: Intismeran autogene (personalized mRNA vaccine) 1 mg IM every 3 weeks for 9 doses then every 12 weeks + pembrolizumab 200 mg IV Q3W for up to 1 year
Primary endpoint: RFS (5-year)
Conclusion: Intismeran autogene in combination with pembrolizumab demonstrated a statistically significant and clinically meaningful improvement in 5-year recurrence-free survival compared with pembrolizumab alone in resected stage III/IV melanoma, with a hazard ratio of 0.51 and 49% reduction in recurrence risk, establishing the first Phase 3 evidence for a personalized mRNA cancer vaccine in solid tumors.
Population: Biopsy-confirmed superficial basal cell carcinoma, lesion size <=20 mm, located on trunk or extremities (excluding hands, feet, genitalia)
Intervention: 5-ALA 20% gel applied to lesion under occlusive dressing for 3 hours then illuminated with red light (630 nm, 37 J/cm2)
Primary endpoint: Complete response rate at 12 weeks
Conclusion: The FDA approved aminolevulinic acid gel in combination with photodynamic therapy using red light illumination for the treatment of superficial basal cell carcinoma, based on a Phase 3 trial demonstrating a complete response rate of 85% versus 22% with placebo at 12 weeks, providing a non-surgical treatment option for patients with low-risk superficial basal cell carcinoma lesions.
ESMO Pancreatic Cancer Guideline Update (daraxonrasib) — Guideline, Phase N/A
Population: KRAS G12C-mutated metastatic pancreatic adenocarcinoma, previously treated with at least one systemic therapy
Intervention: Daraxonrasib monotherapy recommended as standard of care for KRAS G12C-mutant metastatic pancreatic cancer after first-line therapy
Primary endpoint: N/A
Conclusion: ESMO issued an express update to the pancreatic cancer clinical practice guidelines recommending daraxonrasib as standard of care for adults with previously treated KRAS G12C-mutated metastatic pancreatic adenocarcinoma, based on data from the RASolute 302 Phase 3 trial demonstrating improved overall survival and progression-free survival compared with standard chemotherapy, and emphasizing the importance of routine KRAS G12C molecular testing in this patient population.
Population: FGFR2 fusion or rearrangement-positive unresectable locally advanced or metastatic cholangiocarcinoma, previously treated with at least one systemic therapy including gemcitabine-cisplatin
Intervention: Lirafugratinib 20 mg orally once daily on a 21-days-on/7-days-off schedule until progression or unacceptable toxicity
Primary endpoint: ORR (BICR)
Conclusion: The FDA approved lirafugratinib for adults with FGFR2 fusion or rearrangement-positive unresectable locally advanced or metastatic cholangiocarcinoma who have received at least one prior systemic therapy, based on the CIBI351A302 Phase 2 trial demonstrating an objective response rate of 52% and a median duration of response of 10.6 months, representing the first FDA-approved irreversible pan-FGFR inhibitor for this molecular subset of biliary tract cancer.
LITESPARK-011 (belzutifan + lenvatinib) — GU, Phase III
Population: Advanced renal cell carcinoma with clear cell component, progressed on or after PD-1 or PD-L1 inhibitor, or within 6 months of completing adjuvant PD-1 therapy
Intervention: Belzutifan 120 mg orally once daily + lenvatinib 20 mg orally once daily until progression or unacceptable toxicity
Primary endpoint: PFS (BICR)
Conclusion: The FDA approved belzutifan in combination with lenvatinib for adults with advanced renal cell carcinoma with a clear cell component following progression on or after a PD-1 or PD-L1 inhibitor, based on the LITESPARK-011 Phase 3 trial demonstrating a statistically significant improvement in progression-free survival with a median of 14.6 versus 10.6 months and a hazard ratio of 0.74, though the final overall survival analysis did not reach statistical significance with a hazard ratio of 0.85.
Biosimilar (denosumab-adet) — Bone & Sarcoma, Phase N/A
Population: Prevention of skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors; giant cell tumor of bone; hypercalcemia of malignancy refractory to bisphosphonate therapy
Intervention: Denosumab-adet 120 mg SC every 4 weeks (same dosing as reference product)
Primary endpoint: N/A
Conclusion: The FDA approved denosumab-adet as the first biosimilar to denosumab (Xgeva) for the prevention of skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors, treatment of giant cell tumor of bone, and treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy, based on comprehensive analytical, nonclinical, and clinical data demonstrating biosimilarity to the reference product.
BRUIN CLL-313 (pirtobrutinib) — Haematology, Phase III
Population: Previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma without 17p deletion, ECOG PS 0-2
Intervention: Pirtobrutinib 200 mg orally once daily until progression or unacceptable toxicity
Primary endpoint: PFS (IRC)
Conclusion: The FDA approved pirtobrutinib for adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma without 17p deletion, based on the BRUIN CLL-313 Phase 3 trial demonstrating a median progression-free survival that was not estimable versus 33.5 months with bendamustine plus rituximab and a hazard ratio of 0.20, representing an 80% reduction in the risk of disease progression or death and marking the first approval of a non-covalent BTK inhibitor in the frontline setting for this disease.
HER2CLIMB-05 (tucatinib + trastuzumab + pertuzumab) — Breast, Phase III
Population: HER2-positive unresectable locally advanced or metastatic breast cancer, no progression after 4-8 cycles of trastuzumab + pertuzumab + taxane induction, with or without brain metastases
Intervention: Tucatinib 300 mg orally BID + trastuzumab + pertuzumab IV Q3W (or SC fixed-dose combination) until progression or unacceptable toxicity
Primary endpoint: PFS (investigator-assessed)
Conclusion: The FDA approved tucatinib in combination with trastuzumab and pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic HER2-positive breast cancer following induction treatment, based on the HER2CLIMB-05 Phase 3 trial demonstrating a median progression-free survival of 24.9 versus 16.3 months with a hazard ratio of 0.64, representing the first FDA-approved HER2-targeted maintenance regimen for this population and carrying a boxed warning for severe hepatotoxicity.
Population: Stage III mismatch repair deficient colon cancer, complete resection, no residual disease, ECOG PS 0-1; adults and pediatric patients >=2 years
Intervention: Atezolizumab 840 mg IV Q2W + mFOLFOX6 (oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 + 5-FU 400 mg/m2 bolus then 2400 mg/m2 over 46h) Q2W x12 cycles then atezolizumab 1200 mg IV Q3W x6 months
Primary endpoint: DFS (investigator-assessed)
Conclusion: The FDA approved atezolizumab in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of adult and pediatric patients two years of age and older with stage III mismatch repair deficient colon cancer, based on the ATOMIC Phase 3 trial demonstrating a statistically significant improvement in disease-free survival with a hazard ratio of 0.50, representing a 50% reduction in the risk of recurrence or death and establishing the first PD-L1 inhibitor approved in the adjuvant setting for this molecularly defined population.
Population: BCG-unresponsive non-muscle-invasive bladder cancer with high-grade papillary-only tumors (no CIS), after adequate BCG therapy (>=5 instillations of induction or >=2 instillations of maintenance)
Intervention: Nogapendekin alfa inbakicept-pmln 4 mcg intravesical weekly x6 induction then monthly x10 maintenance + BCG intravesical per standard dosing
Primary endpoint: Complete response rate at 6 months
Conclusion: The FDA approved nogapendekin alfa inbakicept-pmln in combination with BCG for the treatment of adults with BCG-unresponsive non-muscle-invasive bladder cancer with high-grade papillary-only tumors, based on the PIVOT-IO Phase 2/3 trial demonstrating a complete response rate of 72% versus 48% and a median duration of complete response of 16.8 versus 8.2 months, representing the first FDA-approved therapy specifically for this challenging subset of bladder cancer patients.
Conclusion: The FDA withdrew the accelerated approval for lurbinectedin for the treatment of adult patients with metastatic small cell lung cancer who progressed on or after platinum-based chemotherapy, effective September 30, 2026, because the confirmatory ATLANTIS Phase 3 trial did not verify clinical benefit, with a median overall survival of 8.6 versus 7.6 months and a hazard ratio of 1.04, representing the second regulatory withdrawal of a small cell lung cancer therapy in 2026.
Conclusion: The FDA withdrew the biologics license application for ifinatamab deruxtecan for the treatment of relapsed small cell lung cancer on September 28, 2026, after Daiichi Sankyo and AstraZeneca voluntarily withdrew the application following feedback from the agency, representing a regulatory setback for this B7-H3-targeted antibody-drug conjugate in the small cell lung cancer setting though development in other tumor types continues.
Population: Resected stage II or III colorectal cancer, ECOG PS 0-1, completed adjuvant chemotherapy if indicated
Intervention: Aspirin 100 mg orally once daily for 3 years
Primary endpoint: DFS
Conclusion: The ASAC Phase 3 trial demonstrated that low-dose aspirin did not improve disease-free survival compared with placebo in patients with resected stage II or III colorectal cancer, with a 3-year disease-free survival of 78.2% versus 79.1% and a hazard ratio of 1.05, representing a negative result that does not support the routine use of aspirin as adjuvant therapy in this population despite prior observational data suggesting potential benefit.
Conclusion: Retlirafusp in combination with CAPOX demonstrated a statistically significant improvement in progression-free survival compared with CAPOX alone in first-line HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma, with a median of 9.8 versus 6.2 months and a hazard ratio of 0.62, representing the first Phase 3 evidence for an IL-15-based immunotherapy combination in gastric cancer and establishing a potential new standard of care for this population.
Conclusion: The updated analysis of the EXCALIBER-RRMM Phase 3 trial demonstrated that iberdomide in combination with daratumumab and hyaluronidase-fihj and dexamethasone significantly improved progression-free survival compared with the control regimen in relapsed or refractory multiple myeloma, with a median progression-free survival of 18.2 versus 10.5 months and a hazard ratio of 0.58, supporting the accelerated approval granted in August 2026 and confirming the clinical benefit of this first CELMoD-based combination.
Clinical impact: Practice-changing
FDA status: Accelerated approval Aug 2026 (full PFS data now reported)
Population: Relapsed or refractory multiple myeloma after >=3 prior lines including PI, IMiD, and anti-CD38 mAb (triple-class exposed)
Intervention: Etentamig SC weekly x12 then Q2W until progression or unacceptable toxicity (dose per protocol)
Primary endpoint: PFS
Conclusion: Etentamig demonstrated a statistically significant improvement in progression-free survival compared with physician choice in relapsed or refractory multiple myeloma after at least three prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, with a median progression-free survival of 14.8 versus 6.2 months and a hazard ratio of 0.48, representing the first Phase 3 evidence for a BCMA-directed bispecific antibody in this heavily pretreated population.
Population: EGFR-mutant advanced NSCLC, progressed on or after osimertinib and platinum-based chemotherapy
Intervention: Firmonertinib 160 mg orally once daily
Primary endpoint: PFS (BICR)
Conclusion: The FURVENT Phase 3 trial demonstrated that firmonertinib did not improve progression-free survival compared with chemotherapy in patients with EGFR-mutant advanced non-small cell lung cancer who had progressed on or after osimertinib and platinum-based chemotherapy, with a median progression-free survival of 4.2 versus 4.8 months and a hazard ratio of 1.12, representing a negative result that does not support the use of this third-generation EGFR tyrosine kinase inhibitor in the post-osimertinib setting.
AHEAD-MERIT (BNT113 + pembrolizumab) — Head & Neck, Phase III
Presented at: ESMO 2026
Population: HPV16-positive recurrent or metastatic head and neck squamous cell carcinoma, treatment-naive in metastatic setting
Intervention: BNT113 100 mcg IM every 3 weeks for 9 doses then every 12 weeks + pembrolizumab 200 mg IV Q3W
Primary endpoint: PFS (BICR)
Conclusion: The interim analysis of the AHEAD-MERIT Phase 3 trial demonstrated that BNT113 in combination with pembrolizumab did not improve progression-free survival compared with pembrolizumab monotherapy in first-line HPV16-positive recurrent or metastatic head and neck squamous cell carcinoma, with a median progression-free survival of 6.8 versus 7.2 months and a hazard ratio of 1.05, representing a negative interim result though the trial will continue to the final overall survival analysis.
Conclusion: Epcoritamab in combination with R-CHOP demonstrated a statistically significant improvement in overall survival compared with R-CHOP alone in previously untreated high-risk diffuse large B-cell lymphoma, with a 2-year overall survival of 82% versus 72% and a hazard ratio of 0.64, representing the first Phase 3 evidence for a CD3-directed bispecific antibody in the first-line treatment of this aggressive lymphoma.
Conclusion: Olaparib demonstrated a statistically significant improvement in invasive disease-free survival compared with placebo in patients with HER2-negative high-risk early breast cancer who had residual disease after neoadjuvant chemotherapy and detectable circulating tumor DNA, with a 3-year invasive disease-free survival of 78% versus 62% and a hazard ratio of 0.52, representing the first Phase 3 evidence for a PARP inhibitor in the molecularly selected ctDNA-positive early breast cancer population regardless of BRCA mutation status.
Population: Non-muscle-invasive bladder cancer (all risk categories)
Intervention: Risk-stratified treatment: BCG induction +/- maintenance for high-risk; intravesical chemotherapy for low/intermediate-risk; nogapendekin alfa + BCG for BCG-unresponsive high-grade papillary
Primary endpoint: N/A
Conclusion: The American Urological Association updated the non-muscle-invasive bladder cancer clinical practice guidelines to incorporate data from the PIVOT-IO trial supporting the use of nogapendekin alfa inbakicept in combination with BCG for BCG-unresponsive high-grade papillary disease, and to refine risk stratification criteria and surveillance recommendations across all risk categories.
Population: Biliary tract cancer (all subtypes); pancreatic adenocarcinoma
Intervention: Molecular profiling recommended for all patients. KRAS G12C-mutant pancreatic cancer: daraxonrasib recommended as standard of care after first-line therapy. FGFR2 fusion-positive cholangiocarcinoma: lirafugratinib recommended.
Primary endpoint: N/A
Conclusion: ASCO updated the biliary tract cancer clinical practice guidelines to incorporate data from the RASolute 302 Phase 3 trial supporting the use of daraxonrasib as standard of care for previously treated KRAS G12C-mutated metastatic pancreatic adenocarcinoma, and to reinforce the importance of comprehensive molecular profiling including KRAS, FGFR2, IDH1, BRAF, MSI-H or dMMR, and NTRK status for all patients with biliary tract and pancreatic cancers.
Population: Myelofibrosis (primary, post-PV, post-ET), all risk categories
Intervention: Risk-stratified treatment: ruxolitinib or fedratinib for symptomatic splenomegaly; momelotinib for symptomatic disease with anemia; allogeneic stem cell transplant for high-risk disease
Primary endpoint: N/A
Conclusion: ASH updated the myelofibrosis clinical practice guidelines to incorporate data from the MOMENTUM Phase 3 trial supporting the use of momelotinib for patients with symptomatic myelofibrosis and anemia, and to provide updated recommendations on risk stratification, treatment sequencing, and the role of allogeneic stem cell transplantation in this disease.
FDA AEMS Q3 2026 (Multiple) — Regulatory, Phase N/A
Population: All patients receiving approved oncology therapies
Intervention: Ongoing pharmacovigilance monitoring via FAERS and AEMS
Primary endpoint: N/A
Conclusion: The FDA Adverse Event Monitoring System identified new safety signals for oncology therapies in the third quarter of 2026, including secondary T-cell malignancies following CAR-T cell therapy with 12 cases reported across approved products, severe cutaneous adverse reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis with KRAS G12C inhibitors with 8 cases, and cardiomyopathy with HER2-directed therapies with 15 new cases, prompting label updates and REMS modifications for the affected products.
The FDA approved nogapendekin alfa inbakicept-pmln in combination with BCG for the treatment of adults with BCG-unresponsive non-muscle-invasive bladder cancer with high-grade papillary-only tumors, based on the PIVOT-IO Phase 2/3 trial demonstrating a complete response rate of 72% versus 48% and a median duration of complete response of 16.8 versus 8.2 months, representing the first FDA-approved therapy specifically for this challenging subset of bladder cancer patients.
Sources: FDA, OncLive
Practice-changing
ATOMIC — atezolizumab + mFOLFOX6
GI · Regulatory Approval
The FDA approved atezolizumab in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of adult and pediatric patients two years of age and older with stage III mismatch repair deficient colon cancer, based on the ATOMIC Phase 3 trial demonstrating a statistically significant improvement in disease-free survival with a hazard ratio of 0.50, representing a 50% reduction in the risk of recurrence or death and establishing the first PD-L1 inhibitor approved in the adjuvant setting for this molecularly defined population.
The FDA approved tucatinib in combination with trastuzumab and pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic HER2-positive breast cancer following induction treatment, based on the HER2CLIMB-05 Phase 3 trial demonstrating a median progression-free survival of 24.9 versus 16.3 months with a hazard ratio of 0.64, representing the first FDA-approved HER2-targeted maintenance regimen for this population and carrying a boxed warning for severe hepatotoxicity.
Sources: FDA, pfizer.com
Practice-changing
EPCORE DLBCL-2 — epcoritamab + R-CHOP
Haematology · First Result
Epcoritamab in combination with R-CHOP demonstrated a statistically significant improvement in overall survival compared with R-CHOP alone in previously untreated high-risk diffuse large B-cell lymphoma, with a 2-year overall survival of 82% versus 72% and a hazard ratio of 0.64, representing the first Phase 3 evidence for a CD3-directed bispecific antibody in the first-line treatment of this aggressive lymphoma.
Sources: OncLive, abbvie.com
Weekly Clinical Updates
Trial results · Guidelines · Regulatory · Conference data
18 trials
Last updated: 14 Oct 2026
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ASH Myelofibrosis Guidelines v2026
momelotinib
📖 Guideline
Informative
ASH updated the myelofibrosis clinical practice guidelines to incorporate data from the MOMENTUM Phase 3 trial supporting the use of momelotinib for patients with symptomatic myelofibrosis and anemia, and to provide updated recommendations on risk stratification, treatment sequencing, and the role of allogeneic stem cell transplantation in this disease.
ASCO updated the biliary tract cancer clinical practice guidelines to incorporate data from the RASolute 302 Phase 3 trial supporting the use of daraxonrasib as standard of care for previously treated KRAS G12C-mutated metastatic pancreatic adenocarcinoma, and to reinforce the importance of comprehensive molecular profiling including KRAS, FGFR2, IDH1, BRAF, MSI-H or dMMR, and NTRK status for all patients with biliary tract and pancreatic cancers.
N/A
Guideline Update
Biliary tract cancer (all subtypes); pancreatic adenocarcinomaComprehensive molecular profiling (KRAS, FGFR2, IDH1, BRAF, MSI-H/dMMR, NTRK) recommended for all BTC and pancreatic cancer patients
ResultN/A
ResultN/A
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14 Oct 2026
PIVOT-IO
nogapendekin alfa inbakicept-pmln + BCG
🔵 GU
Practice-Changing
The FDA approved nogapendekin alfa inbakicept-pmln in combination with BCG for the treatment of adults with BCG-unresponsive non-muscle-invasive bladder cancer with high-grade papillary-only tumors, based on the PIVOT-IO Phase 2/3 trial demonstrating a complete response rate of 72% versus 48% and a median duration of complete response of 16.8 versus 8.2 months, representing the first FDA-approved therapy specifically for this challenging subset of bladder cancer patients.
II/III
Regulatory Approval
BCG-unresponsive non-muscle-invasive bladder cancer with high-grade papillary-only tumors (no CIS), after adequate BCG therapy (>=5 instillations of induction or >=2 instillations of maintenance)High-grade papillary-only NMIBC; BCG-unresponsive per FDA definition
CR rate72% vs 48% | p<0.0001Duration of CR16.8 vs 8.2 mo
DFS18.5 vs 10.2 mo | HR 0.55 (95% CI 0.38-0.79) | p=0.001Cystectomy-free85% vs 68% at 12 moSafetyLocal bladder symptoms most common; manageable
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Most common AEs: dysuria, frequency/urgency, hematuria, fatigue, nausea
Grade>=3 AEs: manageable; no systemic cytokine release syndrome
No new safety signals
FDAApproved Oct 2026
14 Oct 2026
AHEAD-MERIT
BNT113 + pembrolizumab
🦷 Head & Neck
Negative
The interim analysis of the AHEAD-MERIT Phase 3 trial demonstrated that BNT113 in combination with pembrolizumab did not improve progression-free survival compared with pembrolizumab monotherapy in first-line HPV16-positive recurrent or metastatic head and neck squamous cell carcinoma, with a median progression-free survival of 6.8 versus 7.2 months and a hazard ratio of 1.05, representing a negative interim result though the trial will continue to the final overall survival analysis.
III
First Result
HPV16-positive recurrent or metastatic head and neck squamous cell carcinoma, treatment-naive in metastatic settingHPV16-positive status confirmed by PCR or ISH
PFS6.8 vs 7.2 mo | HR 1.05 (95% CI 0.82-1.34) | p=0.72 | Interim: NOT METORR38% vs 42% | p=0.45
OS (interim)14.5 vs 16.2 mo | HR 1.12 (95% CI 0.85-1.47) | p=0.42 | NOT SIGNIFICANTSafetyConsistent with pembrolizumab alone; injection site reactions 45%ImmunogenicityHPV16-specific T-cell responses detected in 85% of BNT113 patients
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Most common AEs: injection site reactions 45%, fatigue 28%, nausea 15%, pyrexia 12%
Grade>=3 AEs: 38% vs 35%
No unexpected safety signals
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13 Oct 2026
ATOMIC
atezolizumab + mFOLFOX6
🟡 GI
Practice-Changing
The FDA approved atezolizumab in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of adult and pediatric patients two years of age and older with stage III mismatch repair deficient colon cancer, based on the ATOMIC Phase 3 trial demonstrating a statistically significant improvement in disease-free survival with a hazard ratio of 0.50, representing a 50% reduction in the risk of recurrence or death and establishing the first PD-L1 inhibitor approved in the adjuvant setting for this molecularly defined population.
III
Regulatory Approval
Stage III mismatch repair deficient colon cancer, complete resection, no residual disease, ECOG PS 0-1; adults and pediatric patients >=2 yearsdMMR status confirmed by IHC or PCR; stage III disease
DFSNR vs NR | HR 0.50 (95% CI 0.35-0.73) | p=0.0001 | 50% risk reduction
OSImmature at DFS analysisSafetyHigher grade 3-4 AEs in combo arm driven by neutropenia; immune-mediated AEs consistent with atezolizumab profile
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Grade>=3 AEs: higher in combo arm (58% vs 42%) driven by neutropenia
Immune-mediated AEs: consistent with atezolizumab known profile
No new safety signals
FDAApproved Oct 2026
8 Oct 2026
HER2CLIMB-05
tucatinib + trastuzumab + pertuzumab
🎀 Breast
Practice-Changing
The FDA approved tucatinib in combination with trastuzumab and pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic HER2-positive breast cancer following induction treatment, based on the HER2CLIMB-05 Phase 3 trial demonstrating a median progression-free survival of 24.9 versus 16.3 months with a hazard ratio of 0.64, representing the first FDA-approved HER2-targeted maintenance regimen for this population and carrying a boxed warning for severe hepatotoxicity.
III
Regulatory Approval
HER2-positive unresectable locally advanced or metastatic breast cancer, no progression after 4-8 cycles of trastuzumab + pertuzumab + taxane induction, with or without brain metastasesHER2-positive status confirmed; no progression after induction
PFS24.9 vs 16.3 mo | HR 0.64 (95% CI 0.51-0.80) | p<0.0001
OSImmature at PFS analysisORR35% vs 15% (maintenance phase)SafetyHepatotoxicity boxed warning; diarrhea, nausea, fatigue most common
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Boxed warning: hepatotoxicity
Most common AEs: diarrhea, nausea, fatigue, hepatotoxicity, hand-foot syndrome
Grade>=3 AEs: 42% vs 28%
Grade>=3 hepatotoxicity: higher than prior tucatinib experience
FDAApproved Oct 2026
7 Oct 2026
FURVENT
firmonertinib
🫁 Lung
Negative
The FURVENT Phase 3 trial demonstrated that firmonertinib did not improve progression-free survival compared with chemotherapy in patients with EGFR-mutant advanced non-small cell lung cancer who had progressed on or after osimertinib and platinum-based chemotherapy, with a median progression-free survival of 4.2 versus 4.8 months and a hazard ratio of 1.12, representing a negative result that does not support the use of this third-generation EGFR tyrosine kinase inhibitor in the post-osimertinib setting.
III
First Result
EGFR-mutant advanced NSCLC, progressed on or after osimertinib and platinum-based chemotherapyEGFR mutation (exon 19del, L858R, or T790M) confirmed; progression after osimertinib
PFS4.2 vs 4.8 mo | HR 1.12 (95% CI 0.88-1.42) | p=0.36 | Primary endpoint NOT MET
OS12.5 vs 14.2 mo | HR 1.08 (95% CI 0.84-1.39) | p=0.55ORR28% vs 35% | p=0.12SafetyDiarrhea, rash, hepatotoxicity most common
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Most common AEs: diarrhea 45%, rash 32%, nausea 22%, hepatotoxicity 18%, fatigue 15%
Grade>=3 AEs: 42% vs 48%
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6 Oct 2026
EPCORE DLBCL-2
epcoritamab + R-CHOP
🩸 Haematology
Practice-Changing
Epcoritamab in combination with R-CHOP demonstrated a statistically significant improvement in overall survival compared with R-CHOP alone in previously untreated high-risk diffuse large B-cell lymphoma, with a 2-year overall survival of 82% versus 72% and a hazard ratio of 0.64, representing the first Phase 3 evidence for a CD3-directed bispecific antibody in the first-line treatment of this aggressive lymphoma.
OS2-year: 82% vs 72% | HR 0.64 (95% CI 0.48-0.85) | p=0.0018
PFS2-year: 75% vs 62% | HR 0.58 (95% CI 0.44-0.76) | p<0.0001CR68% vs 55% | p=0.002SafetyCRS 18% (grade>=3: 2%); manageable with step-up dosingICANS8% (grade>=3: 2%)
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Most common AEs: neutropenia 52%, CRS 18% (mostly grade 1-2), anemia 35%, thrombocytopenia 28%, ICANS 8%
CRS: manageable with step-up dosing
Infections: 25%
FDAPending
5 Oct 2026
BRUIN CLL-313
pirtobrutinib
🩸 Haematology
Practice-Changing
The FDA approved pirtobrutinib for adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma without 17p deletion, based on the BRUIN CLL-313 Phase 3 trial demonstrating a median progression-free survival that was not estimable versus 33.5 months with bendamustine plus rituximab and a hazard ratio of 0.20, representing an 80% reduction in the risk of disease progression or death and marking the first approval of a non-covalent BTK inhibitor in the frontline setting for this disease.
III
Regulatory Approval
Previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma without 17p deletion, ECOG PS 0-2No 17p deletion; CLL/SLL diagnosis confirmed
PFSNE vs 33.5 mo | HR 0.20 (95% CI 0.11-0.37) | p<0.0001 | 80% risk reductionORR94% vs 81% | p<0.001
OSImmature; 3 vs 10 deaths at analysisCR13% vs 21%SafetyInfections 27%, rash 22%, COVID-19 21%; 28% serious AEs; 4.3% discontinued due to AEs
Olaparib demonstrated a statistically significant improvement in invasive disease-free survival compared with placebo in patients with HER2-negative high-risk early breast cancer who had residual disease after neoadjuvant chemotherapy and detectable circulating tumor DNA, with a 3-year invasive disease-free survival of 78% versus 62% and a hazard ratio of 0.52, representing the first Phase 3 evidence for a PARP inhibitor in the molecularly selected ctDNA-positive early breast cancer population regardless of BRCA mutation status.
III
First Result
HER2-negative high-risk early breast cancer, residual disease after neoadjuvant chemotherapy, detectable ctDNA (MRD-positive) post-surgeryHER2-negative status; detectable ctDNA post-neoadjuvant therapy; high-risk features
IDFS3-year: 78% vs 62% | HR 0.52 (95% CI 0.38-0.71) | p<0.0001DDFS3-year: 82% vs 68% | HR 0.55 (95% CI 0.39-0.77) | p=0.0004
OS3-year: 92% vs 88% | HR 0.68 (95% CI 0.42-1.10) | p=0.12 | ImmatureSafetyAnemia 45%, nausea 32%, fatigue 28%; manageableBRCABenefit seen regardless of BRCA mutation status
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Most common AEs: anemia 45% (grade>=3: 18%), nausea 32%, fatigue 28%, vomiting 15%, headache 12%
Grade>=3 AEs: manageable with dose modification
No new safety signals
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1 Oct 2026
FDA AEMS Q3 2026
Multiple
📋 Regulatory
Informative
The FDA Adverse Event Monitoring System identified new safety signals for oncology therapies in the third quarter of 2026, including secondary T-cell malignancies following CAR-T cell therapy with 12 cases reported across approved products, severe cutaneous adverse reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis with KRAS G12C inhibitors with 8 cases, and cardiomyopathy with HER2-directed therapies with 15 new cases, prompting label updates and REMS modifications for the affected products.
N/A
Updated Analysis
All patients receiving approved oncology therapiesNone required
ResultN/A
ResultN/A
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30 Sept 2026
ATLANTIS
lurbinectedin
🫁 Lung
Negative
The FDA withdrew the accelerated approval for lurbinectedin for the treatment of adult patients with metastatic small cell lung cancer who progressed on or after platinum-based chemotherapy, effective September 30, 2026, because the confirmatory ATLANTIS Phase 3 trial did not verify clinical benefit, with a median overall survival of 8.6 versus 7.6 months and a hazard ratio of 1.04, representing the second regulatory withdrawal of a small cell lung cancer therapy in 2026.
III
Regulatory Approval
Metastatic small cell lung cancer (indication now withdrawn)SCLC diagnosis confirmed
OS8.6 vs 7.6 mo | HR 1.04 (95% CI 0.88-1.23) | p=0.67 | NOT STATISTICALLY SIGNIFICANT
PFS4.0 vs 3.3 mo | HR 0.92ORR32% vs 30%SafetyHigher hematologic toxicity in lurbinectedin arm
The FDA withdrew the biologics license application for ifinatamab deruxtecan for the treatment of relapsed small cell lung cancer on September 28, 2026, after Daiichi Sankyo and AstraZeneca voluntarily withdrew the application following feedback from the agency, representing a regulatory setback for this B7-H3-targeted antibody-drug conjugate in the small cell lung cancer setting though development in other tumor types continues.
II
Regulatory Approval
Relapsed small cell lung cancer (BLA withdrawn; no approved indication)SCLC diagnosis confirmed; progression after platinum-based chemotherapy
ORR55% (IDeate-1); 48% (IDeate-2)DOR6.4 mo (IDeate-1); 5.8 mo (IDeate-2)
SafetyHematologic toxicity, fatigue, nausea most common; ILD/pneumonitis signal
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Most common AEs: neutropenia, thrombocytopenia, fatigue, nausea, anemia
ILD/pneumonitis: signal observed
Grade>=3 AEs: 65%
FDABLA withdrawn Sep 2026
28 Sept 2026
Biosimilar
denosumab-adet
🦴 Bone & Sarcoma
Regulatory
The FDA approved denosumab-adet as the first biosimilar to denosumab (Xgeva) for the prevention of skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors, treatment of giant cell tumor of bone, and treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy, based on comprehensive analytical, nonclinical, and clinical data demonstrating biosimilarity to the reference product.
N/A
Regulatory Approval
Prevention of skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors; giant cell tumor of bone; hypercalcemia of malignancy refractory to bisphosphonate therapyNone required
ResultN/A
ResultN/A
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FDAApproved Sep 2026
28 Sept 2026
CERVINO
etentamig
🩸 Haematology
Practice-Changing
Etentamig demonstrated a statistically significant improvement in progression-free survival compared with physician choice in relapsed or refractory multiple myeloma after at least three prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, with a median progression-free survival of 14.8 versus 6.2 months and a hazard ratio of 0.48, representing the first Phase 3 evidence for a BCMA-directed bispecific antibody in this heavily pretreated population.
III
First Result
Relapsed or refractory multiple myeloma after >=3 prior lines including PI, IMiD, and anti-CD38 mAb (triple-class exposed)Triple-class exposed (PI, IMiD, anti-CD38 mAb)
PFS14.8 vs 6.2 mo | HR 0.48 (95% CI 0.36-0.64) | p<0.0001
ORR68% vs 32% | p<0.0001DoR18.5 vs 8.2 moOSImmature; trend favoring etentamigSafetyCytokine release syndrome 58% (mostly grade 1-2); manageable
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Most common AEs: cytokine release syndrome 58% (grade>=3: 4%), neutropenia 45%, anemia 38%, thrombocytopenia 28%, infections 35%
CRS: mostly grade 1-2; manageable with step-up dosing
ICANS: 5% (grade>=3: 1%)
The updated analysis of the EXCALIBER-RRMM Phase 3 trial demonstrated that iberdomide in combination with daratumumab and hyaluronidase-fihj and dexamethasone significantly improved progression-free survival compared with the control regimen in relapsed or refractory multiple myeloma, with a median progression-free survival of 18.2 versus 10.5 months and a hazard ratio of 0.58, supporting the accelerated approval granted in August 2026 and confirming the clinical benefit of this first CELMoD-based combination.
III
Updated Analysis
Relapsed or refractory multiple myeloma after >=1 prior line including PI and IMiD; excluded if refractory to prior anti-CD38 mAbPrior PI and IMiD exposure required
PFS18.2 vs 10.5 mo | HR 0.58 (95% CI 0.48-0.70) | p<0.0001
MRD- CR41% vs 21% | p<0.0001 (previously reported)OSImmature; trend favoring IberDdSafetyNeutropenia 90%, infections 79%, SPM 3.2% vs 1.8%SPMSecondary primary malignancy signal: 3.2% vs 1.8%
FDAAccelerated approval Aug 2026 (full PFS data now reported)
25 Sept 2026
RELIGHT
retlirafusp + CAPOX
🟡 GI
Practice-Changing
Retlirafusp in combination with CAPOX demonstrated a statistically significant improvement in progression-free survival compared with CAPOX alone in first-line HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma, with a median of 9.8 versus 6.2 months and a hazard ratio of 0.62, representing the first Phase 3 evidence for an IL-15-based immunotherapy combination in gastric cancer and establishing a potential new standard of care for this population.
III
First Result
HER2-negative advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, treatment-naive in metastatic settingHER2-negative status confirmed
PFS9.8 vs 6.2 mo | HR 0.62 (95% CI 0.51-0.75) | p<0.0001
OSImmature; trend favoring retlirafusp armORR58% vs 42% | p<0.001DoR8.5 vs 5.2 moSafetyCytokine release syndrome 12% (mostly grade 1-2); manageable
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Most common AEs: cytokine release syndrome 12% (grade>=3: 2%), nausea 45%, neutropenia 38%, fatigue 32%, diarrhea 28%
CRS: mostly grade 1-2; manageable with supportive care
No new safety signals
FDAPending
24 Sept 2026
LITESPARK-011
belzutifan + lenvatinib
🔵 GU
Practice-Changing
The FDA approved belzutifan in combination with lenvatinib for adults with advanced renal cell carcinoma with a clear cell component following progression on or after a PD-1 or PD-L1 inhibitor, based on the LITESPARK-011 Phase 3 trial demonstrating a statistically significant improvement in progression-free survival with a median of 14.6 versus 10.6 months and a hazard ratio of 0.74, though the final overall survival analysis did not reach statistical significance with a hazard ratio of 0.85.
III
Regulatory Approval
Advanced renal cell carcinoma with clear cell component, progressed on or after PD-1 or PD-L1 inhibitor, or within 6 months of completing adjuvant PD-1 therapyClear cell RCC component required; prior PD-1/PD-L1 therapy required
PFS14.6 vs 10.6 mo | HR 0.74 (95% CI 0.61-0.89) | p=0.001ORR53% vs 40% | p=0.0002
OS33.7 vs 28.6 mo | HR 0.85 (95% CI 0.70-1.03) | p=0.10 | NOT STATISTICALLY SIGNIFICANTSafetyHigher toxicity in combo arm; anemia, hypoxia, hypertension, fatigue most common
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Most common AEs: anemia, hypoxia, hypertension, fatigue, diarrhea, proteinuria, decreased appetite, nausea
Grade>=3 AEs: 72% vs 58%
Serious AEs: 38% vs 28%
FDAApproved Sep 2026
24 Sept 2026
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Clinical reference only. These guidelines are intended to support, not replace, clinical judgment. Treatment decisions should be individualised based on patient-specific factors, local protocols, and multidisciplinary team input. Always apply clinical judgment and consult local institutional guidelines where applicable.