Oncology Clinical Guidelines

Beamion LUNG-1 (zongertinib) — Lung, Phase I

Presented at: ELCC 2026

Population: Advanced/metastatic non-squamous NSCLC with HER2 TKD activating mutations; treatment-naïve; ECOG PS 0-1; 30% brain mets

Intervention: Zongertinib 120 mg PO QD (<90kg) or 180 mg (≥90kg)

Primary endpoint: ORR (BICR) — 76%

Median PFS: 14.4 months

Conclusion: Zongertinib showed sustained efficacy in previously untreated patients with advanced HER2-mutant NSCLC. Treatment-related adverse events were predominantly low-grade.

Clinical impact: Informative

FDA status: Approved Feb 2026 — accelerated approval for HER2-mutant NSCLC first-line

Source: NEJM

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)

Source: AACR

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

Source: FDA.gov

OptimUM-02 (darovasertib + crizotinib) — Skin, Phase II/III

Presented at: Not yet presented

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)

Source: OncLive

eNRGy (zenocutuzumab) — GI, Phase I/II

Presented at: N/A

Population: Adults with advanced unresectable or metastatic cholangiocarcinoma harboring NRG1 gene fusion

Intervention: Zenocutuzumab-zbco (Bizengri) — HER3 × EGFR bispecific antibody

Primary endpoint: ORR — 36.8%

Conclusion: If approved, zenocutuzumab would be the first targeted therapy specifically indicated for NRG1 fusion-positive cholangiocarcinoma.

Clinical impact: Informative

FDA status: Pending — sBLA submitted Apr 14, 2026; orphan drug designation Feb 2026; already approved Dec 2024 for NRG1+ NSCLC and pancreatic cancer

Source: OncLive

— GI, Phase N/A

Presented at: N/A

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.

Clinical impact: Informative

FDA status: N/A

Source: ESMO

(immune checkpoint inhibitors (class-wide)) — Other, Phase N/A

Presented at: AACR 2026

Population: Cancer patients receiving ICI therapy who developed myocarditis; n=2,641 ICI-myocarditis cases from WHO VigiBase

Intervention: N/A — retrospective database analysis

Primary endpoint: Myocarditis fatality prediction — N/A

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.

Clinical impact: Informative

FDA status: N/A

Source: AACR

NCT05327270 (nivolumab) — Head & Neck, Phase I

Presented at: AACR 2026

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.

Clinical impact: Early signal

FDA status: N/A

Source: AACR

MajesTEC-3 (teclistamab + daratumumab hyaluronidase-fihj) — Haematology, Phase III

Presented at: ASH 2025

Population: Relapsed/refractory multiple myeloma with 1–3 prior lines; received PI and IMiD; ECOG PS 0-2

Intervention: Teclistamab 1.5 mg/kg SC step-up (D1,8,15) then Q3W + daratumumab 1800 mg SC Q3W

Primary endpoint: PFS — 89.0% vs 75.3%

Median PFS: NR vs 18.1 months

Median OS: NR vs NR (HR 0.46) months

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)

Source: FDA.gov

SWOG S1826 (nivolumab + doxorubicin + vinblastine + dacarbazine (AVD)) — Haematology, Phase III

Presented at: ASH 2025

Population: Previously untreated, Stage III or IV classical Hodgkin lymphoma; age ≥12; adolescents and adults enrolled

Intervention: Nivolumab 240 mg IV Q2W + AVD (doxorubicin 25 mg/m², vinblastine 6 mg/m², dacarbazine 375 mg/m²) Q2W × 6 cycles

Primary endpoint: PFS — N/A

Median PFS: NR vs NR months

Median OS: NR vs NR months

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

Source: FDA.gov

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)

Source: FDA.gov

TOP (osimertinib + pemetrexed + carboplatin) — Lung, Phase III

Presented at: ELCC 2026

Population: Previously untreated stage IV or recurrent non-squamous NSCLC with EGFR-sensitizing mutations and concurrent TP53 mutations

Intervention: Osimertinib 80 mg PO QD + pemetrexed 500 mg/m² + carboplatin AUC5 Q3W × 4 cycles → osimertinib + pemetrexed maintenance

Primary endpoint: PFS (BICR) — 82.9% vs 71.6%

Median PFS: 34.0 vs 15.6 months

Conclusion: These findings provide key evidence to support a molecular risk-guided, individualized treatment strategy for EGFR-mutated advanced NSCLC.

Clinical impact: Informative

FDA status: N/A (not yet submitted)

Source: Medscape

(toripalimab) — Lung, Phase III

Presented at: ELCC 2026

Population: Adult patients with untreated recurrent or metastatic non-squamous NSCLC; measurable disease; no EGFR-sensitizing mutations or ALK fusions

Intervention: Subcutaneous toripalimab 360 mg Q3W × 4 cycles + pemetrexed + platinum → SC toripalimab + pemetrexed maintenance

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.

Clinical impact: Informative

FDA status: N/A (approved in China only)

Source: Medscape

CEPHEUS (daratumumab + hyaluronidase-fihj + bortezomib + lenalidomide + dexamethasone (VRd)) — Haematology, Phase III

Presented at: EHA 2025

Population: Newly diagnosed multiple myeloma (NDMM) in patients ineligible for autologous stem cell transplant (ASCT); age ≥18; ECOG PS 0-2

Intervention: Daratumumab + hyaluronidase-fihj SC 1800 mg + VRd (bortezomib 1.3 mg/m² SC D1,4,8,11 + lenalidomide 25 mg PO D1-21 + dexamethasone 40 mg PO D1,4,8,11) Q21D × 6 cycles → dara-Rd maintenance

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)

Source: FDA.gov

KEYNOTE-B96 (pembrolizumab + paclitaxel) — Gynaecology, Phase III

Presented at: ESMO 2024

Population: Platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer; 1–4 prior lines; PD-L1 CPS≥1; ECOG PS 0-1; measurable disease

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)

Source: FDA.gov

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)

Source: FDA.gov

BREAKWATER (encorafenib + cetuximab + mFOLFOX6) — GI, Phase III

Presented at: ESMO 2024

Population: Previously untreated BRAF V600E-mutated metastatic colorectal cancer; ECOG PS 0-1; measurable disease; RAS wild-type

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)

Source: FDA.gov

Beamion LUNG-1 (zongertinib (Hernexeos)) — Lung, Phase I

Presented at: ELCC 2026

Population: Advanced/metastatic non-squamous NSCLC with HER2 TKD activating mutations; treatment-naïve for advanced disease

Intervention: Zongertinib 120 mg PO QD (<90kg) or 180 mg (≥90kg)

Primary endpoint: ORR (BICR) — 76%

Median PFS: 14.4 months

Conclusion: Zongertinib is the first FDA-approved therapy specifically indicated for HER2 tyrosine kinase domain-mutant non-small cell lung cancer.

Clinical impact: Regulatory

FDA status: Approved Feb 26, 2026 — accelerated approval for HER2-mutant NSCLC first-line (under CNPV pilot program); orphan drug designation

Source: FDA.gov

KEYNOTE-B15 / EV-304 (enfortumab vedotin + pembrolizumab) — GU, Phase III

Presented at: N/A

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)

Source: NEJM

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.

Clinical impact: Informative

FDA status: N/A (not yet submitted)

Source: ASCO

— Breast, Phase N/A

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.

Clinical impact: Practice-changing

FDA status: N/A

Source: NCCN

(datopotamab deruxtecan, sevabertinib, osimertinib + pemetrexed + platinum) — Lung, Phase N/A

Population: EGFR-mutant advanced NSCLC post-progression on frontline osimertinib-based therapy; HER2-mutant NSCLC post-progression

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.

Clinical impact: Practice-changing

FDA status: N/A

Source: NCCN

(belantamab mafodotin + bortezomib + dexamethasone, linvoseltamab, isatuximab + bortezomib + lenalidomide + dexamethasone) — Haematology, Phase N/A

Population: Relapsed/refractory multiple myeloma after 2+ prior lines (belantamab+Bd); after 4+ prior lines including anti-CD38, PI, IMiD (linvoseltamab); newly diagnosed transplant-eligible (isa+VRd)

Intervention: Belantamab mafodotin 2.5 mg/kg IV Q3W + bortezomib + dexamethasone Category 1; linvoseltamab 50 mg SC step-up; isatuximab + VRd Category 1 preferred for HSCT candidates

Primary endpoint: N/A — N/A

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.

Clinical impact: Practice-changing

FDA status: N/A

Source: NCCN

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.

Primary endpoint: Diagnostic accuracy (PPV, specificity) — N/A

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.

Clinical impact: Regulatory

FDA status: Approved Mar 2026

Source: FDA.gov

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

Source: FDA.gov

PRIMA (niraparib) — Gynaecology, Phase III

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

Source: FDA.gov

(capecitabine, fluorouracil) — Regulatory, Phase N/A

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)

Source: FDA.gov

KROCUS (fulzerasib + cetuximab) — Lung, Phase II

Presented at: ELCC 2026

Population: Previously untreated KRAS G12C-mutant advanced NSCLC

Intervention: Fulzerasib (KRAS G12C inhibitor) + cetuximab (EGFR mAb)

Primary endpoint: ORR — Not reported

Median PFS: Not reported months

Median OS: Not reported months

Conclusion: KROCUS trial evaluating first-line fulzerasib plus cetuximab in KRAS G12C-mutant NSCLC. Full data not yet available in peer-reviewed publication.

Clinical impact: Early signal

FDA status: N/A

Source: OncoAlert

VIKTORIA-1 (gedatolisib + fulvestrant ± palbociclib) — Breast, Phase III

Presented at: SABCS 2025

Population: HR+/HER2- PIK3CA wild-type metastatic breast cancer, post-CDK4/6 inhibitor + aromatase inhibitor

Intervention: Gedatolisib (PI3Kα/mTOR inhibitor) + fulvestrant ± palbociclib

Primary endpoint: PFS — Not reported

Median PFS: Not reported months

Median OS: Not reported months

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.

FDA status: N/A

Source: OncoAlert

PANOVA-3 (tumor treating fields (Optune Pax) + gemcitabine + nab-paclitaxel) — GI, Phase III

Population: Adults with locally advanced unresectable pancreatic adenocarcinoma, ECOG PS 0-1

Intervention: Optune Pax TTFields device (wearable arrays on abdomen) ≥18 hr/day + gemcitabine 1000 mg/m² + nab-paclitaxel 125 mg/m² D1,8,15 q28d

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

Source: FDA.gov

Dana-Farber IST (axicabtagene ciloleucel (Yescarta)) — Haematology, Phase I

Population: Relapsed/refractory primary CNS lymphoma (PCNSL)

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

Source: FDA.gov

RMC-6236-001 / RMC-GI-102 (daraxonrasib ± gemcitabine + nab-paclitaxel) — GI, Phase I/II

Presented at: AACR 2026

Population: Previously untreated RAS-mutant metastatic pancreatic ductal adenocarcinoma

Intervention: Mono: daraxonrasib 300 mg QD (21-day cycles). Combo: daraxonrasib 200 mg QD + gemcitabine/nab-paclitaxel D1,15 q28d

Primary endpoint: ORR, DCR, 6-mo PFS, 6-mo OS — 47% mono / 58% combo

Median PFS: Immature (6-mo rate 71% mono / 84% combo) months

Median OS: Immature (6-mo rate 83% mono / 90% combo) months

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

Source: AACR

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.

Clinical impact: Early signal

FDA status: N/A

Source: AACR

(elisrasib (D3S-001)) — Lung, Phase I/II

Presented at: AACR 2026

Population: KRAS G12C-mutated locally advanced or metastatic NSCLC, previously treated with immunotherapy and/or platinum doublet chemotherapy

Intervention: Elisrasib orally once daily in 21-day cycles at doses 50-900 mg; 600 mg selected as preferred dose

Primary endpoint: ORR, DCR, Safety — ~60% (G12C-inhibitor naive) / ~33% (G12C-inhibitor experienced)

Median PFS: 9-12 mo (naive) months

Median OS: Not mature months

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.

Clinical impact: Early signal

FDA status: N/A — Phase II ongoing

Source: AACR

(autogene cevumeran (BNT122, RO7198457) + atezolizumab) — GI, Phase I

Presented at: AACR 2026

Population: Resected pancreatic ductal adenocarcinoma, adjuvant setting post-surgery

Intervention: Personalized mRNA neoantigen vaccine (autogene cevumeran) + atezolizumab + chemotherapy (adjuvant)

Primary endpoint: Vaccine-induced T-cell response rate — N/A

Median PFS: Not reported months

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

Source: AACR

KEYNOTE-B15 / EV-304 (pembrolizumab + enfortumab vedotin) — GU, Phase III

Population: Muscle-invasive bladder cancer (MIBC) eligible for cisplatin-based chemotherapy

Intervention: Pembrolizumab + enfortumab vedotin perioperative (neoadjuvant + adjuvant)

Primary endpoint: EFS — N/A

Median PFS: N/A (EFS trial) months

Median OS: NR (HR 0.50) months

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

Source: FDA.gov

(trastuzumab + tucatinib) — GI, Phase I/II

Presented at: AACR 2026

Population: HER2-positive locally advanced rectal adenocarcinoma

Intervention: Trastuzumab + tucatinib + chemoradiation (neoadjuvant)

Primary endpoint: ORR, cCR rate — 75% (6/8)

Median PFS: Not reported months

Median OS: Not reported months

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.

Clinical impact: Early signal

FDA status: N/A — investigational

Source: AACR

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

Source: JCO

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

Source: ASCO

COMPANION-002 (tovecimig + gemcitabine + cisplatin) — GI, Phase II/III

Presented at: ASCO 2026

Population: Advanced biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer), first-line, ECOG PS 0-1

Intervention: Tovecimig 15 mg/kg IV Q3W + gemcitabine 1000 mg/m2 + cisplatin 25 mg/m2 D1,8 Q3W

Primary endpoint: PFS (by BICR) — 31% vs 20%

Median PFS: 7.8 vs 6.3 months

Median OS: 11.6 vs 11.0 (HR 0.92, NS) months

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.

Source: ASCO

LAPNET-01 (NP137 (anti-NELL1 monoclonal antibody)) — GI, Phase I/II

Population: Metastatic pancreatic ductal adenocarcinoma (PDAC) or neuroendocrine tumors (NETs), progressed on standard therapy

Intervention: NP137 IV Q2W at 3 mg/kg (PDAC) or 10 mg/kg (NETs)

Primary endpoint: Safety, ORR, PFS — 20% PDAC / 30% NETs

Median PFS: 5.2 PDAC / 7.8 NETs months

Median OS: Not mature months

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.

Clinical impact: Early signal

FDA status: N/A — Phase 2 planned for 2026

Source: NEJM

LITESPARK-012 (pembrolizumab + lenvatinib + belzutifan (Arm A) / pembrolizumab-quavonlimab coformulation + lenvatinib (Arm B)) — GU, Phase III

Population: Advanced clear cell renal cell carcinoma, first-line, previously untreated

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).

Source: Medscape

BRUIN CLL-322 (pirtobrutinib + venetoclax + rituximab) — Haematology, Phase III

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

Source: OncoLive

REZILIENT1 (zipalertinib) — Lung, Phase IIb

Population: Locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, progressed on/after platinum-based chemotherapy, with or without amivantamab

Intervention: Zipalertinib 100mg oral BID, continuous

Primary endpoint: ORR, DoR — 35% (40% chemo-only)

Median PFS: 9.1 months

Median OS: Not reported months

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

Source: FDA.gov

NCT03802695 (Orca-Q (allogeneic T-cell immunotherapy)) — Haematology, Phase I

Population: High-risk hematologic malignancies post-allogeneic hematopoietic stem cell transplantation (HSCT)

Intervention: Orca-Q allogeneic T-cell immunotherapy (high-precision cell therapy)

Primary endpoint: OS, GVHD, Non-relapse mortality — N/A

Median OS: Encouraging (preliminary) months

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

Source: FDA.gov

VERITAC-2 (vepdegestrant) — Breast, Phase III

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

Source: FDA.gov

(ruxolitinib (Jakafi XR)) — Haematology, Phase N/A

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)

Primary endpoint: Bioequivalence (AUC, Cmax) — N/A

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)

Source: FDA.gov

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

Source: FDA.gov

SERENA-6 (camizestrant + palbociclib) — Breast, Phase III

Population: ER+/HER2- advanced/metastatic breast cancer post-progression on first-line AI + CDK4/6 inhibitor, ESR1 mutation detected

Intervention: Camizestrant (next-gen SERD) 36mg + palbociclib 125mg

Primary endpoint: PFS — Not reported

Median PFS: 11.7 vs 6.6 months

Median OS: NR (HR 0.76, immature) months

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.

Source: FDA.gov

TALAPRO-3 (talazoparib + enzalutamide) — GU, Phase III

Presented at: ASCO 2026 (LBA planned)

Population: HRR gene-mutated metastatic castration-sensitive prostate cancer (mCSPC), previously untreated, ECOG PS 0-1, ≤3 months ADT

Intervention: Talazoparib 0.5mg/day + enzalutamide 160mg/day

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

Source: OncoLive

LIBRETTO-432 (selpercatinib) — Lung, Phase III

Population: Resected or definitively treated stage IB-IIIA RET fusion-positive NSCLC, with or without adjuvant chemotherapy

Intervention: Selpercatinib 120mg (<50kg) or 160mg (≥50kg) BID until disease recurrence or unacceptable toxicity

Primary endpoint: EFS (investigator-assessed, stage II-IIIA) — N/A (adjuvant setting)

Median OS: Immature (trending favorably) months

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

Source: OncoLive

PHERGain-2 (trastuzumab + pertuzumab + T-DM1) — Breast, Phase II/III

Presented at: ESMO Breast Cancer 2026

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

Primary endpoint: pCR rate (Arm A) — N/A (neoadjuvant pCR study)

Median OS: N/A (DFS ongoing) months

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

Source: ESMO

DESTINY-Breast11 (trastuzumab deruxtecan) — Breast, Phase III

Presented at: ESMO Breast Cancer 2026

Population: High-risk operable HER2-positive early breast cancer (stage II-III), 18-70 years, ECOG PS 0-1, LVEF ≥50%

Intervention: Multiple T-DXd-containing arms including T-DXd + pertuzumab + THP

Primary endpoint: RCB 0/I rate (correlative analysis) — N/A (neoadjuvant RCB study)

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

Source: ESMO

EAP-Daraxonrasib (daraxonrasib) — GI, Phase N/A

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

Source: FDA.gov

RMC-6236-001 (daraxonrasib) — GI, Phase I/II

Presented at: AACR 2026

Population: Previously treated KRAS G12D-mutated solid tumors (PDAC, NSCLC, CRC, and others)

Intervention: Daraxonrasib monotherapy (dose escalation: 100-1600 mg; RP2D: 1200 mg)

Primary endpoint: ORR, Safety, DCR — 20% PDAC / 48% NSCLC / 35% CRC

Median PFS: 4.2 PDAC months

Median OS: 6.8 PDAC / 12.4 NSCLC / 9.1 CRC months

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

Source: NEJM

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

Source: FDA.gov

VIKTORIA-1 (gedatolisib + fulvestrant ± palbociclib) — Breast, Phase III

Presented at: ASCO 2026

Population: PIK3CA-mutated HR+/HER2- metastatic breast cancer, post-CDK4/6 inhibitor + AI, no prior chemotherapy for mBC

Intervention: Gedatolisib + fulvestrant ± palbociclib

Primary endpoint: PFS — Not disclosed

Median PFS: Not disclosed (ASCO 2026) months

Median OS: Not mature months

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

Source: OncoLive

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.

Clinical impact: Practice-changing

FDA status: Approved May 2026

Source: FDA.gov

BGB-11417-201 (sonrotoclax) — Haematology, Phase I/II

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.

Clinical impact: Practice-changing

FDA status: Accelerated approval May 2026

Source: FDA.gov

eNRGy (zenocutuzumab) — GI, Phase I/II

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)

Source: FDA.gov

VOLGA (durvalumab + enfortumab vedotin) — GU, Phase III

Population: Cisplatin-ineligible or cisplatin-declining MIBC (cT2-4a N0-1 M0) undergoing radical cystectomy — perioperative setting

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.

Clinical impact: Practice-changing

FDA status: sNDA submission planned

Source: OncLive

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.

Source: OncLive

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)

Source: OncLive

KEYNOTE-942 / mRNA-4157-P201 (intismeran autogene + pembrolizumab) — Skin, Phase IIb

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.

Source: Medscape

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.

Clinical impact: Practice-changing

FDA status: Approved May 2026

Source: FDA.gov

DESTINY-Breast05 (trastuzumab deruxtecan) — Breast, Phase III

Population: HER2+ early breast cancer with residual invasive disease after neoadjuvant therapy; OR high-risk early HER2+ BC (neoadjuvant)

Intervention: Trastuzumab deruxtecan 5.4 mg/kg IV Q3W x14 cycles (adjuvant)

Primary endpoint: IDFS (adjuvant) / pCR (neoadjuvant)

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%.

Clinical impact: Practice-changing

FDA status: Approved May 2026

Source: FDA.gov

CLL3001 / BGB-11417-CLL (sonrotoclax) — Haematology, Phase I/II

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.

Clinical impact: Practice-changing

FDA status: Accelerated approval May 2026

Source: FDA.gov

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

Source: OncLive

Junshi-SC-PK (toripalimab) — Head & Neck, Phase III

Population: Nasopharyngeal carcinoma and other approved toripalimab indications

Intervention: Toripalimab SC 3-minute subcutaneous injection

Primary endpoint: PK bioequivalence

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.

Clinical impact: Regulatory

FDA status: N/A

Source: OncLive

KEYNOTE-522 (pembrolizumab + carboplatin + paclitaxel + doxorubicin + cyclophosphamide) — Breast, Phase III

Presented at: ASCO 2026

Population: Previously untreated Stage II-III TNBC; ECOG PS 0-1

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)

Source: ASCO

SARC041 (abemaciclib) — Bone & Sarcoma, Phase III

Presented at: ASCO 2026

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.

Clinical impact: Practice-changing

Source: ASCO

PROTEUS (apalutamide + ADT) — GU, Phase III

Presented at: ASCO 2026

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.

Clinical impact: Practice-changing

Source: ASCO

HARMONi-6 (ivonescimab + chemotherapy) — Lung, Phase III

Presented at: ASCO 2026

Population: First-line advanced squamous NSCLC; ECOG PS 0-1; no prior systemic therapy

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.

Clinical impact: Practice-changing

Source: ASCO

LIBRETTO-432 (selpercatinib) — Lung, Phase III

Presented at: ASCO 2026

Population: Stage IB-IIIA RET fusion+ NSCLC post-definitive surgery/radiation; ECOG PS 0-1

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)

Source: ASCO

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.

Clinical impact: Practice-changing

FDA status: Pending

Source: ASCO

PSMAddition (lutetium Lu 177 vipivotide tetraxetan + enzalutamide or abiraterone) — GU, Phase III

Presented at: ASCO 2026

Population: First-line PSMA-PET positive mCSPC; ECOG PS 0-2

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.

Clinical impact: Practice-changing

FDA status: Approved (mCRPC post-ARPI); sNDA expected H2 2026 (1L mCSPC)

Source: ASCO

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.

Clinical impact: Practice-changing

Source: OncLive

RASolute 302 (daraxonrasib) — GI, Phase III

Presented at: ASCO 2026

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

Source: ASCO

VIKTORIA-1 (inavolisib + palbociclib + fulvestrant) — Breast, Phase III

Presented at: ASCO 2026

Population: PIK3CA-mutant ER+/HER2- metastatic breast cancer; post-CDK4/6 inhibitor; ECOG PS 0-1

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

Source: OncLive

DESTINY-Breast11 (trastuzumab deruxtecan + paclitaxel + trastuzumab + pertuzumab) — Breast, Phase III

Presented at: ESMO Breast 2026

Population: High-risk HER2+ early-stage breast cancer; locally advanced; ECOG PS 0-1

Intervention: T-DXd 5.4 mg/kg IV Q3W x4 cycles -> paclitaxel + trastuzumab + pertuzumab x4 cycles

Primary endpoint: pCR (RCB-0)

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)

Source: ESMO

ChonDRAgon (ozekibart) — Bone & Sarcoma, Phase II

Presented at: ASCO 2026

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.

Clinical impact: Early signal

Source: OncLive