Cogent Biosciences announces trials in patients with GIST completes enrollment

Cogent Biosciences provided several updates from the company’s ongoing registration-directed clinical trials of its potential best-in-class KIT mutant inhibitor, bezuclastinib. Patient enrollment is now complete in Cogent’s Phase 3 PEAK trial evaluating bezuclastinib in combination with sunitinib for the treatment of patients with gastrointestinal stromal tumors or GIST. Based on strong global patient interest, a total of 413 patients were enrolled in the study. In addition, Cogent recently completed a pre-planned interim futility analysis, and the Independent Data Monitoring Committee or IDMC, recommended continuing the PEAK study without modification. …Cogent also announced today that it expects to complete enrollment in this study during Q1 2025, approximately three months earlier than originally projected. “We are excited to announce these important updates to the PEAK and SUMMIT studies…,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “Strong continued interest from patients around the world to participate in our bezuclastinib trials has allowed us to accelerate development and surpass our original enrollment timelines. Completing enrollment in our Phase 3 PEAK trial of bezuclastinib and sunitinib for second-line GIST patients several months ahead of schedule represents a significant milestone for the program and we are extremely grateful to the patients, families, caregivers, advocacy groups and clinical investigators for their participation in, and support of, the PEAK trial.”