Cogent Biosciences Reports Positive FDA Meeting and Agreement on MS2D2 for SUMMIT Trial

On June 27, 2024, Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology firm specializing in precision therapies for genetically defined diseases, announced a significant milestone with the U.S. Food and Drug Administration (FDA). The FDA has agreed on the use of the company's new patient-reported outcome measure, Mastocytosis Symptom Severity Daily Diary (MS2D2), in the SUMMIT trial's Part 2. This trial evaluates the efficacy of bezuclastinib in patients with Nonadvanced Systemic Mastocytosis (NonAdvSM).

Andrew Robbins, President and CEO of Cogent Biosciences, expressed optimism about the FDA’s approval. He highlighted that the company is on schedule to finalize enrollment for SUMMIT Part 2 by the second quarter of 2025, with top-line results anticipated by the end of the same year.

The MS2D2 questionnaire is designed to capture patient symptoms at the beginning and track changes throughout the trial. Eleven of the most common and severe symptoms will be used to formulate the total symptom score (TSS), which will serve as the primary endpoint for evaluating the trial's success in Part 2.

Cogent Biosciences remains on track with several other key clinical trials. The APEX study, focusing on patients with Advanced Systemic Mastocytosis (AdvSM), is projected to complete enrollment by the end of 2024, with top-line results expected by mid-2025. Additionally, the Phase 3 PEAK study, which includes approximately 388 second-line, post-imatinib patients with Gastrointestinal Stromal Tumors (GIST), is progressing rapidly. The company expects to complete PEAK enrollment by the third quarter of 2024 and anticipates releasing top-line results by the end of 2025.

Bezuclastinib, Cogent Biosciences' most advanced clinical candidate, is a selective tyrosine kinase inhibitor specifically designed to inhibit the KIT D816V mutation, which drives systemic mastocytosis by causing uncontrolled mast cell proliferation. This mutation and other KIT exon 17 mutations are also found in patients with advanced GIST, a cancer heavily reliant on oncogenic KIT signaling. 

Apart from bezuclastinib, the Cogent Research Team is working on a portfolio of novel targeted therapies aimed at genetically driven diseases. Their initial targets include mutations in FGFR2, ErbB2, and PI3Kα, which are associated with various serious conditions.

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