Cogent Biosciences, Inc. (COGT) on Monday reported positive topline results from its Phase 3 PEAK trial evaluating bezuclastinib in combination with sunitinib in patients with Gastrointestinal Stromal Tumors (GIST). Following the news, the company's shares surged more than 100%.
The PEAK trial was designed to assess bezuclastinib plus sunitinib versus sunitinib monotherapy in patients with imatinib-resistant or intolerant GIST.
Results showed that the combination achieved a median progression-free survival of 16.5 months, compared with 9.2 months for sunitinib alone. The objective response rate was 46% for the combination therapy versus 26% for sunitinib monotherapy.
This marks the first positive Phase 3 trial in second-line GIST patients in over two decades.
Based on these data, Cogent plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in GIST during the first half of 2026.
Cogent stock had closed at $14.82, up 0.68% on Friday.
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