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Cogent Biosciences Announces Positive Lead-In Data from Ongoing Phase 3 PEAK Trial Evaluating Bezuclastinib in Combination with Sunitinib in Patients with Gastrointestinal Stromal Tumors (GIST)
- Data presented at ASCO annual meeting demonstrate 55% Disease Control Rate (DCR) in heavily pre-treated GIST patients, including 100% DCR and 17% overall
About this update from Cogent Biosciences, Inc.
[{"type":"text","content":"- Data presented at ASCO annual meeting demonstrate 55% Disease Control Rate (DCR) in heavily pre-treated GIST patients, including 100% DCR and 17% overall response rate (ORR) in efficacy evaluable 2nd-line GIST patients; data immature to estimate progression free survival (PFS) - Combination of bezuclastinib and sunitinib is well-tolerated and consistent with published sunitinib monotherapy safety profile - Cogent to host investor webcast Monday, June 5 at 8:00 a.m. ET WALTHAM, Mass. and BOULDER, Colo., June 03, 2023 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced positive lead-in data from its ongoing Phase 3 PEAK trial evaluating the selective KIT D816V inhibitor bezuclastinib in patients with Gastrointestinal Stromal Tumors (GIST). The data are being presented today in a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. “The results presented today from the lead-in portion of the PEAK study are very encouraging, as the data continue to show that the combination of bezuclastinib and sunitinib has impressive clinical activity in highly refractory GIST patients and is well-tolerated,” said Andrew Wagner, M.D., Ph.D., Senior Physician, Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, and Associate Professor of Medicine, Harvard Medical School. “These data reinforce the importance of the ongoing Phase 3 PEAK clinical trial, which has the potential to bring a new standard of care to imatinib-resistant GIST patients.” “These data reinforce our belief that the combination of bezuclastinib and sunitinib has the potential to become a new treatment option for second-line GIST patients,” said Andrew Robbins, President, and Chief Executive Officer at Cogent Biosciences. “We are pleased to demonstrate in a robust clinical dataset that the addition of bezuclastinib to sunitinib does not appear to change the frequency or severity of adverse events associated with sunitinib monotherapy. In addition, we are encouraged by the performance of this combination in second-line GIST patients, the population we are currently enrolling in the Phase 3 PEAK clinical trial, with a disease control rate of 100% and 4 out of 7 patients now on treatment for mor...