Shots:
- Cogent Biosciences has reported the P-III (PEAK) trial data assessing bezuclastinib + sunitinib vs sunitinib monotx. in pts with imatinib-resistant or intolerant GIST; the US FDA’s NDA filing is planned for H1’26
- As of Sep 30, 2025, trial met its 1EP of improved PFS (mPFS: 16.5 vs 9.2mos.) & showed ORR of 46% vs 26%; OS data remains immature. Detailed data to be presented in a meeting by H1’26
- Also, Cogent plans to report topline data from the APEX trial in Advanced Systemic Mastocytosis (AdvSM) in Dec 2025, present multiple bezuclastinib data incl. 2 SUMMIT trial presentations at ASH’25, & submit its NDA for NonAdvSM by 2025 end
Ref: Cogent Biosciences | Image: Cogent Biosciences | Press Release
Related News:- Genentech (Roche) Reveals P-III Trials Findings on Fenebrutinib in Relapsing and Primary Progressive Multiple Sclerosis
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