Cogent Submits NDA for Bezuclastinib in GIST After Strong Phase 3 Data
Event summary
- Cogent Biosciences submitted an NDA for bezuclastinib in GIST under FDA's RTOR program, following positive Phase 3 PEAK trial results.
- Bezuclastinib combination demonstrated 16.5-month mPFS and 46% ORR in imatinib-resistant GIST patients.
- Breakthrough Therapy Designation for bezuclastinib in GIST was granted earlier this year.
- Cogent plans to present full PEAK trial results at a major medical meeting in H1 2026.
The big picture
Cogent's NDA submission for bezuclastinib represents a significant step in the treatment of second-line GIST, an area with limited therapeutic options. The strong Phase 3 data positions bezuclastinib as a potential game-changer, with the RTOR program expediting its review. The submission also underscores the growing emphasis on precision therapies targeting genetically defined diseases.
What we're watching
- Regulatory Timing
- The pace at which the FDA reviews the bezuclastinib NDA under the RTOR program.
- Clinical Expansion
- Whether Cogent can successfully initiate and execute its Phase 2 trial for first-line GIST patients.
- Competitive Positioning
- How bezuclastinib's efficacy data will position it against existing and emerging therapies for GIST.
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