Cogent Biosciences' Lead Cancer Drug Cuts Disease Progression Or Death Risk By 50% In Stomach Cancer Trial

Cogent Biosciences, Inc. (NASDAQ:COGT) stock is trading higher on Monday, with a session volume of 10.95 million compared to the average volume of 1.97 million as per data from Benzinga Pro.

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The biotechnology company focused on precision therapies for genetically defined diseases, revealed data from its Phase 3 PEAK trial of bezuclastinib plus Pfizer Inc.’s (NYSE:PFE) Sutent (sunitinib) in patients with imatinib-resistant or intolerant Gastrointestinal Stromal Tumors (GIST).

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Data

The combination reached a median progression-free survival (mPFS) of 16.5 months compared to sunitinib monotherapy, which reached a mPFS of 9.2 months. 

In addition, the combination of bezuclastinib with sunitinib resulted in a 46% objective response rate (ORR) compared to 26% with sunitinib monotherapy. 

As of the cutoff date, September 30, 2025, the top-line results for the bezuclastinib combination demonstrated a substantial and highly statistically significant clinical benefit on the primary endpoint of progression-free survival (PFS), reducing the risk of disease progression or death compared to the current standard of care by 50%.

At the time of this analysis, data for overall survival remain immature.

Based on these data and the number of ongoing patients receiving treatment on the bezuclastinib arm, the estimated mean duration of treatment for the bezuclastinib combination is projected to exceed 19 months.

As of the data cutoff, the bezuclastinib combination was generally well tolerated, and no unique risks were observed with the novel combination when compared to the known safety profile of sunitinib.

What Next?

Complete analysis of the Phase 3 PEAK data is ongoing, and Cogent plans to present detailed results at a major medical conference in the first half of 2026. 

Based on these data, Cogent is on track to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in GIST in the first half of 2026.

COGT Price Action: Cogent Biosciences shares were up 124.02% at $33.20 at the time of publication on Monday. The stock is trading at a new 52-week high, according to Benzinga Pro data.

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