Cogent Biosciences Completes Enrollment and Passes Interim Analysis in Phase 3 GIST Trial

Cogent Biosciences, Inc., a biotechnology company specializing in precision treatments for genetically defined diseases, has announced significant progress in their clinical trials of bezuclastinib, a promising KIT mutant inhibitor. The company, listed on Nasdaq under the ticker COGT, has successfully completed patient enrollment in its Phase 3 PEAK trial, which is investigating the efficacy of bezuclastinib combined with sunitinib for treating gastrointestinal stromal tumors (GIST). The trial saw the participation of 413 patients, surpassing its initial target.

The PEAK trial, characterized as a randomized, open-label, global Phase 3 study, aims to compare the combination of bezuclastinib and sunitinib against sunitinib alone in GIST patients who have undergone prior treatment with imatinib. The primary focus of the trial is median progression-free survival (mPFS). Recently, an interim futility analysis was completed without suggesting any changes to the study's design. This analysis predominantly focused on progression-free survival as evaluated by an independent central review.

In parallel, Cogent has also made strides in its SUMMIT trial, which is investigating bezuclastinib for nonadvanced systemic mastocytosis (NonAdvSM). Due to considerable patient interest, the company now anticipates completing enrollment by the first quarter of 2025, three months ahead of schedule. The SUMMIT trial, designed as a randomized, blind, global study, aims to evaluate the improvement in patient symptoms over 24 weeks and is intended to support a New Drug Application (NDA) for NonAdvSM.

Andrew Robbins, President and CEO of Cogent Biosciences, expressed enthusiasm about these developments, highlighting the accelerated enrollment timelines and recognizing the contributions of patients, families, caregivers, advocacy groups, and clinical investigators. The successful and early enrollment completion in the PEAK trial marks a critical milestone for the program, potentially expediting the development process.

Furthermore, Cogent Biosciences has announced the appointment of Darara Dibabu as the Vice President of Marketing. With a robust background in the biopharmaceutical industry, including roles at Pfizer, SeaGen, Bayer, and Merck, Mr. Dibabu brings extensive experience to the role. Notably, he led the global launch and marketing strategy for TUKYSA, a treatment for metastatic breast cancer, at Pfizer and SeaGen. In recognition of his role, Mr. Dibabu was granted an equity award consisting of options to purchase 100,000 shares of Cogent common stock, with a 10-year term and a four-year vesting schedule.

Cogent Biosciences continues to focus on developing targeted therapies for diseases driven by genetic mutations. Apart from bezuclastinib, the company's research team is also advancing a portfolio of novel treatments targeting mutations in FGFR2, ErbB2, and PI3Kα. The company operates from its bases in Waltham, Massachusetts, and Boulder, Colorado.

These advancements underscore Cogent Biosciences' commitment to addressing serious, genetically driven diseases and represent significant progress in their clinical programs. The upcoming milestones, including the expected top-line results from the PEAK trial by the end of 2025 and the SUMMIT trial's completion in the first quarter of 2025, are eagerly anticipated as the company continues to push forward in its mission to develop precision therapies.