Globenewswire·2026-01-20 13:00Core Insights - The PEAK trial is the first study to show statistical significance over an active comparator in GIST patients, with the combination of bezuclastinib and sunitinib achieving a median progression-free survival (mPFS) of 16.5 months and an overall response rate (ORR) of 46% in patients previously treated with imatinib [1][2] Group 1: FDA Approval and Clinical Trial Results - The FDA has accepted Cogent Biosciences' New Drug Application (NDA) for bezuclastinib in combination with sunitinib for GIST patients who have received prior treatment with imatinib under the Real-Time Oncology Review (RTOR) program [1][4] - The bezuclastinib combination demonstrated a 50% reduction in the risk of disease progression or death compared to the current standard of care, with a hazard ratio of 0.50 (95% CI: 0.39 – 0.65) [2] - The mPFS for the bezuclastinib combination was 16.5 months compared to 9.2 months for sunitinib monotherapy, and the ORR was 46% for the bezuclastinib combination versus 26% for sunitinib [2] Group 2: Safety and Future Plans - The bezuclastinib combination was generally well tolerated, with no unique risks observed compared to the known safety profile of sunitinib [3] - Cogent plans to present full results from the PEAK trial at a major medical meeting in the first half of 2026 and will initiate a Phase 2 trial in mid-2026 for first-line GIST patients with exon 9 mutations [5][8] Group 3: Company Overview - Cogent Biosciences is focused on developing precision therapies for genetically defined diseases, with bezuclastinib being a selective tyrosine kinase inhibitor targeting the KIT D816V mutation and other mutations in KIT exon 17 [6] - The company is also developing a portfolio of targeted therapies aimed at various mutations, including FGFR2/3, ErbB2, PI3Kα, KRAS, and JAK2 [6]