Oncology Today—April 6, 2026

This week’s Oncology update highlights regulatory progress, late-stage clinical milestones, pivotal trial initiations, and expanding global development activity across solid tumors.

In Today’s Newsletter

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🫁 Pralsetinib final ARROW publication in RET+ NSCLC [1] [31 Mar 2026]

https://www.rigel.com/investors/news-events/press-releases/detail/434/rigel-announces-publication-of-final-arrow-clinical-trial
Context: Phase 1/2 ARROW final dataset added 42 months of follow-up in metastatic RET fusion-positive NSCLC.
Key point: Rigel said pralsetinib delivered durable responses and manageable safety, with ORR of 70% in measurable disease and median OS of 44.3 months.
Implication: May influence prescriber choice and payer reviews pending full data.

🧬 Agenus starts Phase 3 BATTMAN in MSS mCRC [2] [Global • 01 Apr 2026]

https://investor.agenusbio.com/news/news-details/2026/Agenus-Announces-First-Patient-Enrolled-in-Global-Phase-3-BATTMAN-Trial-of-BOTBAL-Immunotherapy-Combination-in-MSS-or-pMMR-Metastatic-Colorectal-Cancer/default.aspx
Context: BATTMAN (CO.33) is a global, cooperative-group Phase 3 study in refractory unresectable MSS or pMMR metastatic colorectal cancer, targeting about 830 patients across more than 100 sites.
Key point: Agenus announced first-patient-in for botensilimab plus balstilimab versus best supportive care in a registrational-enabling trial.
Implication: May influence prescriber choice and payer reviews pending full data.

🇪🇺 Serplulimab gets two positive CHMP opinions [3] [EU • 30 Mar 2026]

https://www.henlius.com/en/NewsDetails-5825-26.html
Context: The opinions cover serplulimab plus chemotherapy for first-line nsqNSCLC and for PD-L1-positive unresectable locally advanced, recurrent or metastatic ESCC.
Key point: Henlius said CHMP recommended both indications, sending the applications to the European Commission for final decision.
Implication: May influence prescriber choice and payer reviews pending full data.

🎗️ Anbenitamab Phase 3 neoadjuvant breast cancer readout [4] [China • 01 Apr 2026]

https://www.alphamabonc.com/en/html/news/2778.html Context: KN026-004 is an open-label randomized Phase 3 trial in about 520 patients with HER2-positive early or locally advanced breast cancer.
Key point: Alphamab Oncology said anbenitamab plus HB1801 met the primary endpoint of tpCR and significantly outperformed trastuzumab plus pertuzumab plus docetaxel ± carboplatin.
Implication: May influence prescriber choice and payer reviews pending full data.

📄 Bezuclastinib NDA filed in post-imatinib GIST [5] [US • 01 Apr 2026]

https://investors.cogentbio.com/news-releases/news-release-details/cogent-biosciences-announces-submission-new-drug-application-0
Context: The filing is based on Phase 3 PEAK, which compared bezuclastinib plus sunitinib against sunitinib alone in imatinib-resistant GIST.
Key point: Cogent submitted an NDA under FDA RTOR and highlighted Phase 3 data showing mPFS of 16.5 months and ORR of 46% for the combination.
Implication: Introduces competition that may affect pricing and formulary access.

🧪 Daraxonrasib enters Phase 3 first-line metastatic PDAC [6] [Global • 02 Apr 2026]

https://ir.revmed.com/news-releases/news-release-details/revolution-medicines-begins-treating-patients-phase-3-rasolute
Context: RASolute 303 is a global randomized open-label Phase 3 study in previously untreated metastatic PDAC, enrolling regardless of tumor RAS genotype.
Key point: Revolution Medicines said patient treatment has started for daraxonrasib as monotherapy and with gemcitabine plus nab-paclitaxel versus chemotherapy alone.
Implication: May influence prescriber choice and payer reviews pending full data.

🩺 EMERALD-3 meets PFS endpoint in earlier liver cancer [7] [02 Apr 2026]

https://www.astrazeneca.com/media-centre/press-releases/2026/imfinzi-imjudo-improves-pfs-in-early-liver-cancer.html
Context: EMERALD-3 tested durvalumab plus tremelimumab, lenvatinib and TACE in embolisation-eligible unresectable HCC.
Key point: AstraZeneca reported statistically significant and clinically meaningful PFS improvement versus TACE alone, with an OS trend at interim analysis.
Implication: May influence prescriber choice and payer reviews pending full data.

🇪🇺 KEYTRUDA regimen approved in EU platinum-resistant ovarian cancer [8] [EU • 02 Apr 2026]

https://www.merck.com/news/european-commission-approves-keytruda-pembrolizumab-plus-paclitaxel-%c2%b1-bevacizumab-for-the-treatment-of-adults-with-pd-l1-cps-%e2%89%a51-platinum-resistant-recurrent-ovarian-carcinoma-wh/
Context: Approval covers adults with PD-L1 CPS ≥1 platinum-resistant recurrent ovarian, fallopian tube or primary peritoneal carcinoma after one or two prior systemic regimens.
Key point: Merck said the European Commission approved pembrolizumab plus paclitaxel, with or without bevacizumab, based on KEYNOTE-B96 improvements in PFS and OS.
Implication: Introduces competition that may affect pricing and formulary access.

🚀 CTIM-76 gains FDA Fast Track in PROC [9] [US • 02 Apr 2026]

https://ir.contexttherapeutics.com/news-releases/news-release-details/context-therapeutics-announces-ctim-76-receives-fda-fast-track
Context: CTIM-76 is a CLDN6 x CD3 T-cell engager in an ongoing Phase 1 study across CLDN6-positive ovarian, endometrial and testicular cancers.
Key point: Context Therapeutics said FDA granted Fast Track designation for platinum-resistant ovarian cancer after standard-of-care therapies.
Implication: Signals pipeline investment and modality expansion.

🧭 ORIC selects rinzimetostat Phase 3 dose in mCRPC [10] [31 Mar 2026]

https://investors.oricpharma.com/news-releases/news-release-details/oricr-pharmaceuticals-reports-selection-rinzimetostat-rp3d
Context: Dose selection came from a Phase 1b combination study with darolutamide in post-abiraterone metastatic castration-resistant prostate cancer.
Key point: ORIC selected rinzimetostat 400 mg once daily as the recommended Phase 3 dose and said Himalayas-1 is expected to start in 1H 2026.
Implication: May influence prescriber choice and payer reviews pending full data.

Why it matters

• Multiple late-stage oncology programs moved from data to execution this week, including NDA filing, EC approval, CHMP opinions, and new Phase 3 starts [3][5][6][8][10].
• GI oncology was especially active, spanning colorectal cancer, liver cancer, GIST, and ovarian cancer with regulatory and pivotal-trial milestones [2][5][7][8][9].
• China-originated assets continued expanding outward, with serplulimab advancing in Europe and anbenitamab reporting a Phase 3 breast cancer win [3][4].
• Several updates centered on biomarker-defined or genomically selected populations, including RET fusion-positive NSCLC, PD-L1-positive ovarian cancer, CLDN6-positive tumors, and post-abiraterone mCRPC [1][8][9][10].
• Earlier-line treatment ambition remains a theme, with daraxonrasib moving into first-line metastatic PDAC and immunotherapy combinations moving into embolisation-eligible HCC [6][7].