Cogent Biosciences Soars on Positive Phase 3 PEAK Results in Gastrointestinal Stromal Tumors (GIST)

Cogent Biosciences announced positive topline data from the Phase 3 PEAK trial of bezuclastinib plus sunitinib in patients with imatinib-resistant or intolerant gastrointestinal stromal tumors (GIST) on November 10, 2025123.

The combination therapy achieved a median progression-free survival (mPFS) of 16.5 months versus 9.2 months for sunitinib monotherapy (Hazard Ratio = 0.50; p<0.0001)1234.

Objective response rate (ORR) was significantly higher at 46% for the combination compared to 26% for sunitinib monotherapy (p<0.0001)123.

No new combination-specific safety risks were identified; the safety profile was consistent with known sunitinib risks including hypertension, neutropenia, and elevated liver enzymes12.

Cogent’s stock price surged by 120% following release of the positive trial results2.

This is the first positive Phase 3 trial in second-line GIST patients in over 20 years, with experts calling the results practice-changing and expecting rapid adoption as the new standard of care after regulatory approval2.

Cogent plans to submit a New Drug Application (NDA) for bezuclastinib in GIST in the first half of 2026 and will present full PEAK data at scientific conferences in the same period123.

Sources:

1. https://www.stocktitan.net/news/COGT/cogent-biosciences-reports-positive-results-from-bezuclastinib-peak-sla6vnqvenru.html

2. https://uk.investing.com/news/stock-market-news/cogent-biosciences-stock-soars-after-positive-phase-3-cancer-drug-results-93CH-4359659

3. https://www.delveinsight.com/blog/pharma-news-for-cogent-biosciences-anaptys-eledon

4. https://www.gurufocus.com/news/3198181/cogent-biosciences-cogt-reports-promising-phase-3-trial-results