Registration-enabling SUMMIT Part 2 initiated and actively enrolling at 40 sites globally; RP2D selected at 100 mg once-daily optimized formulation based on:
- 51% week 12 mean change in Total Symptom Score (TSS), including 70% of patients achieving ≥50% reduction in TSS at week 12
- 49% week 12 mean improvement in quality-of-life (McQoL)
- Safety and tolerability profile generally similar to placebo with no grade 3/4 events; no bleeding, edema or cognitive events; no dose reductions and no discontinuations
Cogent to host investor webcast tomorrow, February 23 at 8:00 a.m. ET
WALTHAM, Mass. and BOULDER, Colo., Feb. 22, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today reported positive Part 1b data from the Company’s ongoing SUMMIT trial evaluating bezuclastinib in patients with nonadvanced systemic mastocytosis (NonAdvSM) at the 2024 American Academy of Allergy Asthma & Immunology Annual Meeting (AAAAI) meeting taking place February 23-26, 2024 in Washington, D.C.
“The results from SUMMIT Part 1b show that bezuclastinib has the potential to provide NonAdvSM patients with a potent and well-tolerated KIT inhibitor that can drive rapid and clinically meaningful impact across a multitude of symptoms resulting in an impressive improvement in overall quality of life,” said PD Dr. Frank Siebenhaar, M.D., Head University Outpatient Clinic, Institute of Allergology, Charité - Universitätsmedizin Berlin.
“We are pleased to announce these positive results from our SUMMIT Part 1b trial, the specifics of our new MS2D2 symptomatic severity PRO measure, and the news that we have initiated SUMMIT Part 2, with extremely positive support from the NonAdvSM community,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “The magnitude and speed of symptomatic reductions, along with corresponding improvements in quality-of-life, reported by patients in SUMMIT Part 1b has not been seen previously with other treatment options in this patient population. We are fully dedicated to our three actively enrolling, registration-directed clinical trials and see a clear path to establishing bezuclastinib as the best-in-class KIT mutant inhibitor for patients fighting systemic mastocytosis and gastrointestinal stromal tumors.”
Patient DemographicsSUMMIT is a randomized, double-blind, placebo-controlled, global, multicenter, Phase 2 clinical trial of bezuclastinib in patients with NonAdvSM. Thirty-four patients in Part 1b were treated with either bezuclastinib or placebo plus best supportive care. The median age of patients at study entry was 52 years (ranging from 27-76 years). Patients were enrolled with the following sub-types: 33 patients with indolent systemic mastocytosis (ISM) and one patient with smoldering systemic mastocytosis (SSM). One patient had received prior avapritinib.
Safety DataThe majority of treatment emergent adverse events were low grade and reversible with no bleeding or cognitive impairment events reported across cohorts. There were no dose reductions in the 100 mg cohort and two dose reductions in the 150 mg cohort (Grade 1 ALT and Grade 2 abdominal pain). Only one serious adverse event (SAE) was reported in the 150mg cohort in which a patient experienced ALT/AST increase that led to discontinuation.
Pharmacodynamic DataThirty-four patients enrolled in SUMMIT Part 1b were evaluated for signs of clinical activity over 12 weeks, including well-accepted biomarkers of disease burden. At the recommended phase 2 dose (RP2D) of 100 mg once daily bezuclastinib, results showed:
- 100% of patients with baseline tryptase ≥20ng/mL achieved