Oncology Today—April 14, 2026

This week’s Oncology update highlights regulatory progress, pivotal clinical data, financing support, and partnership activity across multiple solid tumor programs.

In Today’s Newsletter

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🧠 REYOBIQ gets pediatric glioma orphan status [1] [US • 08 Apr 2026]

https://ir.plustherapeutics.com/news-releases/news-release-details/plus-therapeutics-granted-us-fda-orphan-drug-designation
Context: REYOBIQ (Plus Therapeutics, rhenium Re186 obisbemeda) is in development for CNS tumors, including recurrent GBM, leptomeningeal metastases, and pediatric brain cancer.
Key point: FDA granted orphan drug designation for REYOBIQ in pediatric malignant gliomas, with Plus saying the scope also covers pediatric ependymoma.
Implication: Introduces competition that may affect pricing and formulary access.

🎯 CRB-701 moves toward registrational studies in HNSCC and cervical cancer [2] [US • 07 Apr 2026]

https://ir.corbuspharma.com/news-events/press-releases/detail/463/corbus-pharmaceuticals-announces-broad-alignment-with-fda-on-registration-path-for-crb-701-in-second-line-hnscc-and-cervical-cancer
Context: CRB-701 (Corbus Pharmaceuticals, Nectin-4 ADC) has Fast Track designation in HNSCC and cervical cancer.
Key point: Corbus reported broad FDA alignment on single randomized registrational studies in second-line HNSCC and cervical cancer, with ORR proposed for potential accelerated approval and OS for potential full approval.
Implication: May influence prescriber choice and payer reviews pending full data.

🫁 Neladalkib NDA filed in ALK-positive NSCLC [3] [US • 07 Apr 2026]

https://investors.nuvalent.com/2026-04-07-Nuvalent-Announces-Submission-of-New-Drug-Application-to-FDA-for-Neladalkib-in-TKI-Pre-treated-Advanced-ALK-positive-NSCLC
Context: Neladalkib (Nuvalent, ALK-selective inhibitor) is being developed for advanced ALK-positive NSCLC after prior ALK TKI treatment.
Key point: Nuvalent submitted an FDA NDA based on data from the registration-directed ALKOVE-1 Phase 1/2 trial in TKI pre-treated patients.
Implication: May influence prescriber choice and payer reviews pending full data.

💰 MAIA says financing should carry Phase 3 ateganosine trial [4] [US • 08 Apr 2026]

https://ir.maiabiotech.com/news-events/press-releases/detail/172/maia-biotechnology-expects-recent-33-million-capital-raise
Context: Ateganosine (MAIA Biotechnology, THIO) is in the THIO-104 pivotal Phase 3 trial in third-line NSCLC.
Key point: MAIA said net proceeds from its recent $33 million offering are expected to fully fund the ongoing pivotal Phase 3 study through completion.
Implication: Signals pipeline investment and modality expansion.

🤝 Boehringer and BioNTech team up in ES-SCLC [5] [Germany • 09 Apr 2026]

https://www.boehringer-ingelheim.com/science-innovation/human-health-innovation/boehringer-biontech-partnership-advance-sclc-therapy
Context: The planned Phase Ib/II study will combine obrixtamig (Boehringer Ingelheim, DLL3/CD3 T-cell engager) with pumitamig (BioNTech and Bristol Myers Squibb, PD-L1/VEGF-A bispecific antibody).
Key point: Boehringer Ingelheim and BioNTech signed a clinical trial collaboration and supply agreement to test the combination in extensive-stage small cell lung cancer.
Implication: Signals pipeline investment and modality expansion.

🇨🇳 DB-1303/BNT323 application accepted in HER2-positive breast cancer [6] [China • 09 Apr 2026]

https://www.dualitybiologics.com/news/606.html
Context: DB-1303/BNT323 (DualityBio and BioNTech, HER2 ADC) was compared with T-DM1 in a Phase III China study in previously treated HER2-positive unresectable or metastatic breast cancer.
Key point: DualityBio said China’s NMPA accepted the application after the pivotal study met its primary endpoint of PFS, with statistically and clinically significant improvement versus T-DM1.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 CatalYm doses first patient in Phase 2b HCC study [7] [07 Apr 2026]

https://www.catalym.com/catalym-doses-first-patient-in-phase-2b-trial-evaluating-visugromab-in-combination-with-chemoimmunotherapy-as-second-line-treatment-in-unresectable-metastatic-hepatocellular-carcinoma/
Context: GDFATHER-HCC-01 is evaluating visugromab (CatalYm, anti-GDF-15 antibody) with nivolumab and lenvatinib in second-line unresectable or metastatic HCC after anti-PD-(L)1 therapy.
Key point: CatalYm announced first patient dosed in the randomized Phase 2b trial, its third Phase 2b program for visugromab.
Implication: Signals pipeline investment and modality expansion.

📘 Lifyorli posts survival win in ROSELLA and lands guideline momentum [8] [US • 10 Apr 2026]

https://ir.corcept.com/news-releases/news-release-details/corcept-presents-complete-data-pivotal-rosella-trial-sgo-late
Context: Lifyorli (Corcept, relacorilant) plus nab-paclitaxel was studied in the Phase 3 ROSELLA trial in platinum-resistant ovarian cancer.
Key point: Corcept reported final overall survival data showing a 35% reduction in risk of death, simultaneous Lancet publication, and NCCN preferred-regimen inclusion after FDA approval in March 2026.
Implication: May influence prescriber choice and payer reviews pending full data.

🧬 GSK advances B7-H4 ADC in gynaecological cancers [9] [09 Apr 2026]

https://www.gsk.com/en-gb/media/press-releases/gsk-presents-positive-data-for-b7-h4-targeted-adc-in-gynaecological-cancers/
Context: Mocertatug rezetecan (GSK, B7-H4 ADC) was evaluated in the Phase I BEHOLD-1 study in platinum-resistant ovarian cancer and recurrent or advanced endometrial cancer.
Key point: GSK reported confirmed ORR of 62% in ovarian cancer and 67% in endometrial cancer at the highest doses evaluated, supporting five Phase III starts in 2026.
Implication: May influence prescriber choice and payer reviews pending full data.

🧫 Phanes starts dose expansion for spevatamig in biliary tract cancer [10] [US • 07 Apr 2026]

https://www.phanesthera.com/news/phanes-therapeutics-announces-dose-expansion-in-clinical-study-of-spevatamig-in-combination-with-chemotherapy-for-treatment-of-biliary-tract-cancer/
Context: Spevatamig (Phanes Therapeutics, claudin 18.2/CD47 bispecific antibody) is being studied with chemotherapy in biliary tract cancer.
Key point: Phanes initiated dose expansion after dose-limiting toxicity clearance at two dose levels.
Implication: Signals pipeline investment and modality expansion.

Why it matters

• Regulatory momentum led the week, with orphan designation, FDA alignment, NDA submission, and NMPA acceptance across multiple programs [1][2][3][6].
• ADC activity remained strong across head and neck, cervical, breast, ovarian, and endometrial cancers, led by CRB-701, DB-1303/BNT323, and mocertatug rezetecan [2][6][9].
• Lung cancer updates spanned multiple modalities, including neladalkib in ALK-positive NSCLC, ateganosine in third-line NSCLC, and a new ES-SCLC combination from Boehringer Ingelheim and BioNTech [3][4][5].
• Corcept’s ROSELLA update stood out for near-term practice relevance, linking Phase 3 survival data, FDA approval, Lancet publication, and NCCN preferred-regimen inclusion in the same cycle [8].
• Earlier-stage development also moved forward, with CatalYm and Phanes advancing novel antibody programs in hard-to-treat solid tumors [7][10].

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