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# Cogent’s Bezuclastinib Combo Delivers Phase 3 Win
- URL: https://www.fdaweb.com/cogents-bezuclastinib-combo-delivers-phase-3-win/
- Published: 2025-11-10T12:00:00.000Z
- Updated: 2026-09-14T15:26:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160192

Cogent Biosciences is reporting positive data from a Phase 3 study of its KIT inhibitor bezuclastinib, saying that the drug combined with standard therapy sunitinib significantly extended progression-free survival in patients with imatinib-resistant or intolerant gastrointestinal stromal tumors (GIST). It is the first successful Phase 3 study in the second-line setting in more than 20 years, the company says.

In the global PEAK trial, the bezuclastinib–sunitinib combination achieved a median progression-free survival of 16.5 months, compared with 9.2 months for sunitinib alone, Cogent says. The objective response rate also nearly doubled, from 26% with sunitinib monotherapy to 46% with the combination.

Cogent said it plans to submit an NDA to the FDA for bezuclastinib in GIST in the first half of 2026 and will present full results at a scientific meeting next year.

Additionally, the company says the combination was generally well tolerated, with no new safety signals beyond what is known for sunitinib. The most common Grade 3 or greater adverse events included hypertension, neutropenia, elevated liver enzymes, anemia and diarrhea. ALT/AST elevations were mostly transient and resolved; 1.5% of patients discontinued bezuclastinib due to hepatic labs.