COGT - Cogent Biosciences Announces Additional Clinical Data from Part 1 of its Ongoing SUMMIT Trial Evaluating Bezuclastinib in Patients with NonAdvanced Systemic Mastocytosis (NonAdvSM) | Benzinga
Patients treated with 100 mg bezuclastinib showed substantial reduction in their most severe symptoms and mast cell reactions
Reductions were shown in all individual MS2D2 symptoms across domains and objective reduction in skin lesions corresponding with symptomatic improvement
WALTHAM, Mass. and BOULDER, Colo., June 14, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (NASDAQ:COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced additional data from Part 1 of its ongoing SUMMIT clinical trial evaluating the selective KIT D816V inhibitor, bezuclastinib, in patients with nonadvanced systemic mastocytosis (NonAdvSM). The data are being presented today in a poster presentation at the 2024 European Hematology Association (EHA) Congress taking place in Madrid, Spain.
"We are excited to share additional analyses from SUMMIT Part 1 which highlight substantial symptomatic reductions as well as improvement in objective measures of disease," said Andrew Robbins, Chief Executive Officer at Cogent Biosciences. "We remain on track to complete enrollment in the registration-directed SUMMIT Part 2 study in the second quarter of 2025 and report topline results by year-end 2025."
"Nonadvanced systemic mastocytosis is a debilitating hematologic disorder and physicians and patients remain in search of more effective treatment options to fight this disease," said Lindsay Rein, MD, Associate Professor of Medicine in the Division of Hematologic Malignancies and Cellular Therapy at Duke University. "I am impressed with the rapid patient response and reductions seen across all domains at 12 weeks as well as the safety and tolerability. I believe bezuclastinib shows promise in treating nonadvanced systemic mastocytosis where significant unmet needs remain."
SUMMIT Trial Update
SUMMIT is a randomized, double-blind, placebo-controlled, global, multicenter, Phase 2 clinical trial of bezuclastinib in patients with NonAdvSM. Part 1 of the trial was designed to determine the recommended dose of bezuclastinib. In addition, the study was designed to explore the effects of bezuclastinib on the signs and symptoms of NonAdvSM, including assessment of disease-specific symptom severity using a novel patient-reported outcome measure, the Mastocytosis Symptom Severity Daily Diary (MS2D2). As of the cutoff date, December 18, 2023, patients in Part 1 treated at the recommended dose of 100 mg bezuclastinib demonstrated >90% reductions across all markers of mast cell burden. Additional data also show ...