Cogent Biosciences Reports Positive Results from Bezuclastinib PEAK Phase 3 Trial in Gastrointestinal Stromal Tumors (GIST)

Core Insights - Cogent Biosciences reported positive results from the Phase 3 PEAK trial of bezuclastinib plus sunitinib in patients with imatinib-resistant or intolerant Gastrointestinal Stromal Tumors (GIST) [2][3] - The combination therapy achieved a median progression-free survival (mPFS) of 16.5 months, significantly higher than the 9.2 months observed with sunitinib monotherapy [2][4] - The objective response rate (ORR) for the bezuclastinib combination was 46%, compared to 26% for sunitinib alone, indicating a substantial improvement in treatment efficacy [2][4] Clinical Trial Results - The PEAK trial demonstrated a 50% reduction in the risk of disease progression or death, with a hazard ratio of 0.50 (95% CI: 0.39 – 0.65) [4] - The trial results are the first positive Phase 3 outcomes for second-line GIST patients in over 20 years, marking a significant milestone in treatment options [2][3] - The estimated mean duration of treatment for the bezuclastinib combination is projected to exceed 19 months [5] Safety Profile - The bezuclastinib combination was generally well tolerated, with no unique risks compared to sunitinib's known safety profile [6] - Common Grade 3+ treatment emergent adverse events included hypertension (29.4% vs. 27.4% for sunitinib), neutropenia (15.2% vs. 15.4%), and ALT/AST increases (10.8% vs. 1.4%) [6] - Discontinuation rates due to treatment-related adverse events were 7.4% for the bezuclastinib combination and 3.8% for sunitinib monotherapy [6] Future Plans - Cogent plans to submit a new drug application (NDA) to the U.S. FDA for bezuclastinib in GIST in the first half of 2026 [2][12] - Detailed results from the PEAK trial will be presented at a scientific conference in the first half of 2026 [2][7] - The company is also preparing for additional presentations and data releases related to its other clinical programs [12]