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Cogent Biosciences Announces SUMMIT Continues to Showcase Powerful Symptomatic Improvement in NonAdvanced Systemic Mastocytosis Patients
Cogent BiosciencesCogent Biosciences(US:COGT) Newsfilterยท2025-02-27 13:00

Core Insights - Cogent Biosciences announced expanded clinical results from the SUMMIT trial evaluating bezuclastinib for nonadvanced systemic mastocytosis, showing a 65% mean improvement in Total Symptom Score (TSS) at 48 weeks, with 88% of patients achieving at least a 50% reduction in TSS [1][6] Group 1: Clinical Trial Results - The SUMMIT trial is a registration-directed, randomized, double-blind, placebo-controlled study involving patients with nonadvanced systemic mastocytosis, with results focusing on those who received 100 mg bezuclastinib for at least 48 weeks [3] - Updated clinical data indicate a 63% reduction from baseline in the most severe symptom at 48 weeks, and quality of life improved to mild as early as week four, sustained through 48 weeks as measured by the Mastocytosis Quality-of-Life scale [6] Group 2: Safety and Patient Outcomes - The median duration of bezuclastinib treatment was 56 weeks for active patients and 40 weeks for placebo patients who crossed over to the Open Label Extension [4] - Most treatment-emergent adverse events were low grade and reversible, with common events including hair discoloration and transaminase elevations, all of which were asymptomatic and reversible [4] Group 3: Future Plans - Top-line results from SUMMIT Part 2 are expected in July 2025, with the company aiming to make bezuclastinib available to all nonadvanced systemic mastocytosis patients as quickly as possible [2][8]