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Cogent Biosciences Announces Positive Top-line Results of APEX Trial of Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM)
-- Bezuclastinib demonstrated rapid and deep clinical benefit in AdvSM patients resulting in an objective response rate (CR+CRh+PR+CI) of 57% per mIWG
About this update from Cogent Biosciences, Inc.
[{"type":"text","content":"-- Bezuclastinib demonstrated rapid and deep clinical benefit in AdvSM patients resulting in an objective response rate (CR+CRh+PR+CI) of 57% per mIWG criteria and 80% per PPR criteria -- -- Bezuclastinib demonstrated a powerful effect on mast cell burden with 89% of patients achieving ≥50% reduction in bone marrow mast cells or clearance of aggregates – -- Bezuclastinib was very well tolerated with only 14.8% of patients requiring dose reduction and no patients requiring discontinuation due to treatment related adverse events -- -- APEX NDA submission expected in 1H 2026 – -- Cogent to host investor conference call and webcast today at 8:00 a.m. ET -- WALTHAM, Mass. and BOULDER, Colo., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (NASDAQ: COGT) today announced positive top-line results from the registration-directed APEX Part 2 clinical trial of bezuclastinib in patients with advanced systemic mastocytosis (AdvSM) demonstrating clinically meaningful results as measured by consensus criteria used to assess patient response. This is the third positive pivotal trial result for bezuclastinib in 2025, following positive announcements from the SUMMIT trial in NonAdvSM patients and the PEAK trial in GIST patients earlier this year. Based on these top-line data, Cogent expects to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in AdvSM during the first half of 2026. In addition, Cogent plans to present detailed data from the APEX trial at an upcoming scientific meeting in the first half of 2026. “We are excited to announce the third positive pivotal trial for bezuclastinib this year. The results from the APEX trial demonstrate the clear benefit that a highly selective, highly potent KIT mutant inhibitor is capable of providing to patients with AdvSM,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “Coupling rapid, deep, durable responses with the safety and tolerability profile demonstrated by bezuclastinib provides these patients with a new choice to fight their disease without compromising their quality of life. With positive results from APEX, taken together with data from SUMMIT and PEAK, Cogent is preparing for multiple commercial launches in the second half of 2026.” In Part 2 of the APEX trial, 81 AdvSM patients were treated with 150 mg of b...