Cogent Biosciences has submitted a new drug application to the U.S. Food and Drug Administration for bezuclastinib to treat patients with gastrointestinal stromal tumors (GIST) who have already been treated with imatinib.
The application is for bezuclastinib used together with sunitinib. In the Phase 3 PEAK trial, the combination showed clear benefits. Patients receiving both drugs had a median progression-free survival of 16.5 months, compared to 9.2 months with sunitinib alone. The response rate was also higher at 46% versus 26%.
The treatment was generally well tolerated, with no new safety concerns compared to sunitinib alone. Common side effects included high blood pressure and low white blood cell counts, while liver-related effects were mostly mild and manageable.
The application was submitted through the FDA’s Real-Time Oncology Review program, which is designed to speed up the approval process for promising cancer treatments. More detailed results from the trial are expected in early 2026, and the company also plans to begin another study testing this combination as a first-line treatment for certain GIST patients.