Cogent Biosciences Announces New SUMMIT Trial Results
Cogent Biosciences announced additional clinical results from the SUMMIT trial with bezuclastinib in patients with NonAdvanced Systemic Mastocytosis at the American Academy of Allergy Asthma & Immunology, AAAAI, Annual Meeting. As previously reported, bezuclastinib demonstrated clinically meaningful and highly statistically significant improvements across the primary and all key secondary endpoints. Treatment with bezuclastinib resulted in rapid, durable, statistically significant symptomatic improvements which continued to deepen out to 48 weeks: Patients on bezuclastinib reported a -32.0 point mean change in TSS, representing a 56% relative improvement in TSS from baseline; 86% of patients achieved a clinically meaningful threshold of 30% improvement in symptoms; 99% of patients had at least 50% reduction in serum tryptase, with 83.3% of patients achieving normalization. Bezuclastinib demonstrates strong evidence of disease modification in NonAdvSM patients based on: Significant correlation shown between serum tryptase reduction and symptomatic improvement as measured by TSS, all symptom domains, and 10/11 individual symptoms; Clinically meaningful improvements in bone mineral density at week 24 for patients treated with bezuclastinib, regardless of baseline bone health severity; 50% of patients reported a dose reduction and/or discontinuation of best supportive care medicines during the treatment period at week 48
