Oncology Video Recap—February 2, 2026

This biweekly video recap in oncology summarizes regulatory actions, late-stage clinical progress, notable data releases, and access-relevant developments across major markets

🎯 Watch Our Video Summary Capturing Oncology News from the Last Two Weeks

Dive deeper

🗓️ Explore more details and sources

Week 12 January–18 January 2026
Weeks 19 January 2026 – 25 January 2026

📚 See the full Oncology archive on our research hub page.

Transcript

Welcome to the latest edition of Oncology Updates, covering breakthroughs in the past two weeks. Brought to you by LucidQuest. Scope, United States, European Union, China, Japan.

The FDA accepted the NDA for gedatolisib for HR positive, HER2 negative, PIK3CA wild type advanced breast cancer, with Priority Review and a PDUFA target of 17 Jul 2026. The filing is based on the PIK3CA wild type cohort of the Phase 3 VIKTORIA-1 study. As a multi target PI3K, AKT, mTOR inhibitor in PIK3CA wild type disease, it could influence pricing and formulary access.

The FDA agreed to accept an NDA under RTOR for bezuclastinib plus sunitinib in post imatinib gastrointestinal stromal tumor, and the company has initiated a rolling submission targeted to complete by April 2026. In PEAK, median progression free survival was 16.5 months versus 9.2 months with sunitinib alone, with higher response rates, while overall survival remains immature.

The FDA granted Breakthrough Therapy designation to sofetabart mipitecan, an FR alpha targeted antibody drug conjugate with an exatecan payload, for adults with platinum resistant ovarian cancer after bevacizumab and mirvetuximab. Early Phase 1 results showed responses across FR alpha expression levels with acceptable tolerability, and the Phase 3 FRAmework-01 trial is underway.

In China, ENHERTU was approved for second line HER2 positive gastric or gastroesophageal junction cancer. DESTINY-Gastric04 showed an overall survival hazard ratio of 0.70 versus ramucirumab plus paclitaxel, with improvements in progression free survival and objective response rate. This is ENHERTU’s sixth approval in China.

In Japan, an sNDA was filed for PADCEV plus Keytruda as a perioperative option for cisplatin ineligible muscle invasive bladder cancer. EV-303, also called KEYNOTE-905, demonstrated a 60 percent reduction in recurrence, progression, or death and a 50 percent reduction in risk of death versus surgery alone, supporting neoadjuvant plus adjuvant use.

In the European Union, a CHMP positive opinion was issued for AKEEGA, niraparib plus abiraterone with prednisone and androgen deprivation therapy, for metastatic hormone sensitive prostate cancer with BRCA1 or BRCA2 mutations. In AMPLITUDE, the BRCA subgroup achieved a radiographic progression free survival hazard ratio of 0.52, with delayed symptomatic progression and an overall survival trend favoring combination therapy.

Also in the European Union, a CHMP positive opinion supported Zynyz, retifanlimab, plus chemotherapy in first line advanced squamous cell anal carcinoma. POD1UM-303, InterAACT2, showed a 37 percent reduction in risk of progression or death, median progression free survival of 9.3 months versus 7.4 months, and no new safety signals. If approved, it would be the first PD-1 immunotherapy in this setting in the EU.

Elevar Therapeutics submitted an NDA for lirafugratinib for cholangiocarcinoma with FGFR2 fusion or rearrangement after prior therapy. In the Phase 1–2 ReFocus study, the objective response rate was 46.5 percent, median duration of response 11.8 months, and median progression free survival 11.3 months, with a manageable safety profile. The application seeks a second line indication.

Stay ahead in Oncology research! Like, share, and subscribe for our updates. Visit www.lqventures.com or email us at info@lqventures.com for expert healthcare consulting. See you next time!

Why it matters

HER2-mutant NSCLC could gain an oral first-line TKI option if sevabertinib confirms benefit.
BRAF V600E mCRC may see broader chemo-backbone flexibility with BRAFTOVI regimens.
TGCT patients gain a potential systemic option with meaningful symptom outcomes.
RMAT status spotlights momentum for cell therapy in solid tumors.
AI-enabled target discovery continues to seed next-gen ADC pipelines.

🗓️ Explore more details and sources

Week 5 January–11 January 2026
Weeks 12 January 2026 – 18 January 2026

📚 See the full Oncology archive on our research hub page.

FAQ

What is gedatolisib’s review status and timing?

FDA accepted Celcuity’s NDA under RTOR with Priority Review and a 17 Jul 2026 PDUFA date for HR+/HER2-, PIK3CA WT ABC, supported by VIKTORIA-1 cohort data [1].

How strong are PEAK results backing bezuclastinib + sunitinib?

Cogent reports significant PFS benefit vs sunitinib, with higher ORR and tolerability consistent with known profiles; RTOR rolling submission is initiating, OS data are immature [2].

What does Lilly’s BTD cover for sofetabart mipitecan?

BTD is for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after bevacizumab and mirvetuximab; Phase 1 showed responses across FRα levels; Phase 3 is underway [3].

What changed for ENHERTU in China?

NMPA approved 2L HER2+ gastric/GEJ based on DESTINY-Gastric04 OS benefit vs ramucirumab + paclitaxel, moving ENHERTU earlier from prior later-line use [4].

Which EU decisions are pending?

CHMP issued positive opinions for AKEEGA in BRCA1/2-mutated mHSPC based on AMPLITUDE [6], and for Zynyz + chemo in first-line advanced SCAC based on POD1UM-303/InterAACT2 [7]; EC decisions are next.

What is Elevar seeking with lirafugratinib?

An FDA NDA for second-line CCA with FGFR2 fusion or rearrangement, supported by ReFocus ORR, DOR, and PFS with manageable safety [8].

Entities / Keywords

Celcuity, gedatolisib, VIKTORIA-1; Cogent Biosciences, bezuclastinib, PEAK; Eli Lilly, sofetabart mipitecan, FRAmework-01; Daiichi Sankyo, AstraZeneca, ENHERTU, DESTINY-Gastric04; Astellas, Pfizer/Seagen, Merck, PADCEV, Keytruda, EV-303/KEYNOTE-905; Johnson & Johnson, AKEEGA, niraparib, abiraterone, AMPLITUDE; Incyte, Zynyz, retifanlimab, POD1UM-303/InterAACT2; Elevar Therapeutics, lirafugratinib, ReFocus; FDA, CHMP, NMPA, MHLW; RTOR, BTD; HR+/HER2- breast cancer, GIST, ovarian cancer, gastric/GEJ, MIBC, mHSPC, SCAC, cholangiocarcinoma.