NOV 30 2026
Cogent Biosciences — bezuclastinib $COGT
for imatinib-resistant gastrointestinal stromal tumor (GIST)
Accepted MAY 28 2026.
About
Gastrointestinal stromal tumors (GISTs) are aggressive growths in the digestive tract, often driven by faulty KIT gene signals that tell cells to multiply uncontrollably. Bezuclastinib is a targeted pill that blocks the specific mutated KIT protein (D816V) responsible for driving tumor growth in resistant cases. By shutting down this runaway signal, the drug may help slow cancer progression in patients who no longer respond to standard treatments.
Pivotal trial
This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 482 patients
Source: ClinicalTrials.gov
Also in development
Drug Watch — recent news on bezuclastinib
- Bezuclastinib Plus Sunitinib Meets PFS End Point in KIT-Mutant GIST - CancerNetwork
- Bezuclastinib Plus Sunitinib Improves Survival in GIST - Oncology News Central
- Bezuclastinib+sunitinib combo shows 16.5 months median PFS vs 9.2 months for sunitinib alone in GIST patients - Pluang
- Cogent Biosciences (COGT) Reveals Promising Phase 3 Trial Results for Bezuclastinib - GuruFocus
- Bezuclastinib Plus Sunitinib Halves Risk of Progression in Second-Line GIST - Targeted Oncology
Sponsor Watch — recent news on Cogent Biosciences
- Cogent Biosciences Announces Detailed Clinical Data from PEAK Phase 3 Trial with Bezuclastinib in Combination with Sunitinib in Gastrointestinal Stromal Tumors (GIST) at 2026 American Society of Clinical Oncology (ASCO) Annual Meeting
- Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) with Priority Review for Bezuclastinib in Combination with Sunitinib for Patients with GIST
- Cogent Biosciences Announces Multiple Presentations at the European Hematology Association (EHA) 2026 Congress
- Cogent Biosciences (COGT) Valuation After Wider Q1 Loss And Bezuclastinib Regulatory Progress
- Cogent Biosciences Reports Recent Business Highlights and First Quarter 2026 Financial Results