Cognyte reports ‘positive’ updated lead-in data from Phase 3 PEAK trial

Cogent Biosciences announced positive updated lead-in data from the company’s ongoing Phase 3 PEAK trial evaluating the selective and potent KIT mutant inhibitor, bezuclastinib, in combination with sunitinib, in patients with Gastrointestinal Stromal Tumors. The data will be presented in a poster presentation at the American Society of Clinical Oncology Annual Meeting in Chicago, IL on June 1. Cogent also announced today a new Phase 2 clinical trial of bezuclastinib plus sunitinib in later line GIST patients, sponsored by the Sarcoma Alliance for Research through Collaboration and in collaboration with The Life Raft Group and Dana-Farber Cancer Institute. “These data presented today reinforce our excitement that the combination of bezuclastinib and sunitinib has the potential to become a new standard of care for advanced GIST patients,” said Andrew Robbins, President and Chief Executive Officer at Cogent Biosciences. “Coupled with the impressive clinical activity demonstrated by the combination, the addition of bezuclastinib to sunitinib continues to be generally well-tolerated with an encouraging safety profile. We are pleased to report that the pace of enrollment in PEAK is significantly ahead of schedule, and we now expect enrollment to complete in the third quarter of 2024.” “We are also excited today to announce a collaboration with SARC, The Life Raft Group and Dana-Farber on a new Phase 2 clinical trial assessing the potential benefit of bezuclastinib with sunitinib in later line GIST patients who are not eligible for the PEAK study and currently have very limited treatment options,” continued Mr. Robbins.