Cogent Biosciences Advances Clinical Trials and Appoints VP

By Bobby Samwell • Tuesday, September 03 15:20 • Permanent Link

Cogent Biosciences, Inc. (NASDAQ: COGT) has announced significant developments in its ongoing clinical trials and the appointment of a new Vice President of Marketing. Here are the key updates:

Phase 3 Peak Trial:
The phase 3 Peak trial, evaluating bezuclastinib in combination with sunitinib for the treatment of gastrointestinal stromal tumors (GIST), has completed enrollment with 413 patients, surpassing the enrollment target.
A pre-planned interim futility analysis was completed, and the independent data monitoring committee recommended continuing the Peak study without modification.
Top-line results are expected by the end of 2025.
Summit Trial:
The Summit trial, focusing on nonadvanced systemic mastocytosis (nonadvSM), is now on track to complete enrollment in the first quarter of 2025, approximately three months earlier than originally projected.
Top-line results for the Summit trial are expected in the second half of 2025.
Appointment of Vice President of Marketing:
Darara Dibabu has joined Cogent as the Vice President of Marketing. With 25 years of experience in the biopharmaceutical industry, Dibabu previously served as the global brand lead of Tukysa at Pfizer and Seagen, leading the global launch and marketing strategy of the product for metastatic breast cancer patients.
About the Trials:
The Peak trial is a randomized, open-label, global phase 3 clinical trial evaluating bezuclastinib in combination with sunitinib vs. sunitinib alone in GIST patients previously treated with imatinib.
The primary endpoint of the Peak trial is median progression-free survival (mPFS), with the intention to support a new drug application (NDA) in GIST.
The Summit trial is a randomized, blinded, global, registration-directed clinical trial evaluating bezuclastinib vs. placebo in nonadvSM patients, with the primary endpoint being the mean improvement in patient symptoms measured at 24 weeks, also designed to support an NDA in nonadvSM.

These developments mark significant progress in Cogent's efforts to develop precision therapies for genetically defined diseases, particularly in the advancement of bezuclastinib in treating GIST and nonadvSM.

Please note that this information is based on the press release provided by Cogent Biosciences, Inc. Following these announcements, the company's shares moved 3.4%, and are now trading at a price of $11.11. Check out the company's full 8-K submission here.

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