Cogent Biosciences Announces Positive Updated Lead-In Data from Ongoing Phase 3 PEAK Trial Evaluating Bezuclastinib in Combination with Sunitinib in Patients with Gastrointestinal Stromal Tumors (GIST) at ASCO Annual Meeting

Core Insights - Cogent Biosciences announced positive updated lead-in data from the ongoing Phase 3 PEAK trial for bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors (GIST) [1][2] - A new Phase 2 clinical trial for bezuclastinib plus sunitinib in later line GIST patients has been initiated, sponsored by SARC and in collaboration with The Life Raft Group and Dana-Farber Cancer Institute [1][2] PEAK Trial Update - The PEAK trial is a randomized, open-label, global Phase 3 study comparing bezuclastinib plus sunitinib to sunitinib alone in GIST patients previously treated with imatinib [4] - As of April 1, 2024, 42 patients in Part 1 have a median treatment duration of 15.3 months, with a median progression-free survival (mPFS) of 10.2 months for all patients and 19.4 months for second-line patients [4][6] - The objective response rate (ORR) for all patients is 27.5%, while it is 33.3% for the subset of second-line patients, with a disease control rate of 80% overall and 100% in patients with prior imatinib [4][6] Safety Data - The combination of bezuclastinib and sunitinib is well-tolerated, showing no additional severity of adverse events compared to sunitinib monotherapy [5] - Most treatment-emergent adverse events (TEAEs) were low-grade and reversible, with no serious adverse reactions reported since the last data presentation in November 2023 [5] Upcoming Events - The updated data will be presented at the ASCO Annual Meeting on June 1, 2024, with a poster available on the Cogent website [7] - Cogent will participate in the Jefferies Global Healthcare Conference on June 5, 2024, with a live webcast available [10] Future Clinical Development - Enrollment in the PEAK study is expected to complete in Q3 2024, with top-line results anticipated by the end of 2025 [9] - The new Phase 2 trial will evaluate mPFS and safety in 40 patients with GIST who have progressed on sunitinib, focusing on later line patients with limited treatment options [8]