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.
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.
Sources: sanofi.com, sahmcapital.com
Practice-changing
NCCN Breast Cancer v4.2026 — Multiple (see evidence base)
Guideline · Guideline Update
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.
Sources: nccn.org, oncodaily.com
Practice-changing
Krascendo 1 — divarasib
Lung · First Result
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.
Sources: OncLive, roche.com, lungcancerstoday.com
Practice-changing
Precision-T — allogeneic regulatory T cell immunotherapy + HSPC + T cells-vldq
Haematology · Regulatory Approval
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.
Sources: FDA
Weekly Clinical Updates
Trial results · Guidelines · Regulatory · Conference data
9 trials
Last updated: 10 Jul 2026
Conclusion
Phase
Type
Population / Marker
Primary Endpoint Results
Secondary Endpoint Results
Efficacy Summary
Safety Signal
Access
IRAKLIA
isatuximab-irfc (subcutaneous)
🩸 Haematology
Regulatory
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.
III
Regulatory Approval
Multiple myeloma (all approved IV indications)CD38 expression (for isatuximab eligibility)
ORR71.1% (SC OBI) vs 70.5% (IV) | Non-inferiority demonstrated
PKComparable exposure between SC OBI and IVSafetyConsistent with IV formulationIRRReduced vs IV infusionAdmin timeSignificantly shorter than IV infusion
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Grade>=3 AEs: consistent with IV profile
Infusion-site reactions (device-related): expected with SC delivery
No new safety signals identified
Consistent with isatuximab known profile
FDAApproved Jul 2026
10 Jul 2026
NCCN Breast Cancer v4.2026
Multiple (see evidence base)
📖 Guideline
Practice-Changing
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.
N/A
Guideline Update
Recurrent unresectable or stage IV metastatic breast cancer; also covers adjuvant/neoadjuvant updatesPIK3CA, AKT1, PTEN, ESR1 (ctDNA at progression), BRCA1/2 (germline), PD-L1 CPS, MSI-H/dMMR, TMB-H, NTRK, RET, FGFR, HER2 mutations
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.
III
First Result
Previously treated KRAS G12C-mutant advanced or metastatic NSCLC; progressed on prior platinum-based chemotherapyKRAS G12C mutation confirmed
PFSClinically meaningful improvement vs sotorasib/adagrasib | Statistically significant | p significantOSInterim analysis: statistically significant | First KRAS G12Ci to beat another head-to-head on OS
ORRImproved vs comparators (exact figures pending presentation)DoRPending full presentationSafetyConsistent with prior data; manageable and reversible; no new safety signals
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Most common treatment-related events: manageable and reversible
No new safety findings
Consistent with divarasib known safety profile
FDAPending
2 Jul 2026
MANGROVE
zanubrutinib + rituximab
🩸 Haematology
Practice-Changing
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.
III
First Result
Previously untreated mantle cell lymphoma; age >=70 OR age >=60 with comorbidities precluding ASCT; ECOG PS 0-2; no prior systemic therapy for MCLNone required
PFSHR 0.57 (95% CI 0.43-0.76) | p<0.0001 | 43% reduction in risk of progression or death vs BR
OSImmature; strong trend favoring zanubrutinib+rituximab (to be tested at final analysis)ORRPending full presentationDoRPending full presentationIA-PFSPendingSafetyConsistent with known profiles; no new safety signalsPROsPending
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Most common AEs (pooled zanubrutinib population, N=1729):
Decreased neutrophil count: 51%
Decreased platelet count: 41%
Upper respiratory tract infection: 38%
Hemorrhage: 32%
Musculoskeletal pain: 31%
No new safety signals identified
FDAPending
30 Jun 2026
Precision-T
allogeneic regulatory T cell immunotherapy + HSPC + T cells-vldq
🩸 Haematology
Practice-Changing
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.
III
Regulatory Approval
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 donorNone required (8/8 HLA-matched donor required)
cGVHD-free survival 1-yr78% (CI 65-87) vs 38% (CI 26-51) | HR 0.26 | p <0.00001Moderate-to-severe cGVHD cumulative incidence 1-yr13% (CI 5-23) vs 44% (CI 31-56)OS 1-yr94% (CI 86-97) vs 83% (CI 73-90) | HR 0.49 | p 0.118
Result1-yr rate 94% vs 83% (HR 0.49); not statistically significantResultNo graft failure observedResultGenerally consistent with stem cell transplantation; no severe infusion reactionsInfectionsmost common adverse event
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Infections (most common)
No severe infusion reactions observed
No graft failure observed
Consistent with stem cell transplantation expected toxicities
FDAApproved Jun 2026
30 Jun 2026
EPCORE DLBCL-4
epcoritamab + lenalidomide
🩸 Haematology
Practice-Changing
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.
III
First Result
Relapsed or refractory DLBCL after >=1 prior line including anti-CD20 therapy; ECOG PS 0-2; transplant-ineligible or declinedNone required
OSStatistically significant improvement | HR significant (favours epcoritamab+len) | p significantResultSuperior to investigator choice chemotherapy
ResultStatistically significant improvementResultImproved response ratesResultCRS mostly low-grade (Gr3 <5%); manageable with step-up dosingResultConsistent with epcoritamab known profile
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CRS: mostly low-grade (Gr3 <5%)
Neutropenia
Thrombocytopenia
Consistent with epcoritamab + lenalidomide profile; manageable with step-up dosing
FDAPending
29 Jun 2026
ASCO NSCLC v2026.3.1
retifanlimab + platinum chemotherapy
📖 Guideline
Informative
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.
N/A
Guideline Update
First-line advanced or metastatic NSCLC; no actionable driver mutations; any PD-L1 expression statusNone required for retifanlimab indication (PD-L1 testing still recommended to guide overall treatment selection)
ResultN/ABased on POD1UM-204PFS HR 0.66, OS HR 0.72 in PD-L1-negative 1L NSCLC
ResultN/A
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—
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24 Jun 2026
ASCENT-03 / ASCENT-04
sacituzumab govitecan + pembrolizumab
🎀 Breast
Practice-Changing
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.
III
Regulatory Approval
Unresectable or metastatic TNBC; no prior systemic therapy for advanced disease; ECOG PS 0-1None required for combination approval (PD-L1 status guides treatment but not required for testing)
ASCENT-04HR 0.68 (immature)ResultImproved vs chemo in both trialsResultNeutropenia 54%, diarrhoea 10% Gr3; ILD low in TNBCResultConsistent with SG+pembro known profile
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Neutropenia: 54%
Diarrhoea: 10% Gr3
ILD: low incidence in TNBC
Consistent with sacituzumab govitecan + pembrolizumab known profile
FDAApproved Jun 2026 (1L mTNBC, all PD-L1 statuses)
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.
III
Regulatory Approval
HR+/HER2+ locally advanced or metastatic breast cancer; no disease progression after induction with taxane + trastuzumab +/- pertuzumab; ECOG PS 0-1HR+ (IHC >=1%); HER2+; endocrine therapy candidate
PFS44.3 (CI 32.4-56.8) vs 29.1 (CI 23.3-38.6) mo | HR 0.75 (CI 0.59-0.96) | p 0.024-yr PFS rate46.5% vs 38.3%
ResultNot mature at 53.5 mo median FUResultNeutropenia 78% (Gr3 55.9%, Gr4 4.6%); ILD/pneumonitis; embryo-fetal toxicity
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.