Cogent: bezuclastinib combo reduces progression risk by 50% in Phase 3 GIST trial

Cogent Biosciences, Inc.

PEAK trial met primary endpoint: HR 0.50 (95% CI: 0.39–0.65) for progression-free survival.
Median PFS 16.5 months (bezuclastinib + sunitinib) vs 9.2 months (sunitinib alone).
Objective response rate 46% (combo) vs 26% (sunitinib), safety generally manageable.
Company plans NDA submission for NonAdvSM by end 2025; GIST NDA in H1 2026.
Top-line APEX AdvSM trial results expected December 2025; ASH presentations upcoming.

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