The trial demonstrated clinically meaningful and highly statistically significant improvements across the primary and all key secondary endpoints.
These endpoints include patient-reported symptoms and objective measures of mast cell burden. Based on these data, Cogent Biosciences is on track to submit its first new drug application to the U.S. Food and Drug Administration for bezuclastinib in NonAdvSM by the end of 2025.
The SUMMIT trial, conducted by Blueprint Medicines Corporation, was designed to assess the clinical benefit of bezuclastinib versus placebo.
It achieved its primary endpoint with a highly statistically significant difference in the mean change in total symptom score at 24 weeks (p=0.0002).
“We have been eagerly awaiting this day and are thrilled to announce bezuclastinib’s performance in the SUMMIT trial, demonstrating clinically meaningful and statistically significant results across all trial endpoints,” said Andrew Robbins, Cogent Biosciences President and CEO.
