Expanded Access to Bezuclastinib Available for Eligible Patients with GIST
Cogent Biosciences has established an Expanded Access Program (EAP) for bezuclastinib in combination with sunitinib for eligible patients with gastrointestinal stromal tumor (GIST). Expanded access, sometimes called compassionate use, provides a pathway for certain patients with serious illnesses to receive an investigational treatment outside of a clinical trial when satisfactory treatment options are not available.
Bezuclastinib is an investigational KIT inhibitor that was evaluated with sunitinib in the Phase III PEAK trial in patients with locally advanced, unresectable, or metastatic GIST previously treated with imatinib. In PEAK, the combination significantly improved progression-free survival compared with sunitinib alone, with a median progression-free survival of 16.5 months versus 9.2 months. The FDA is currently reviewing Cogent’s application for the combination and has granted it Priority Review, with a target action date of November 30, 2026.
While that review is underway, Cogent’s Expanded Access Program provides a potential avenue for eligible U.S. patients to receive bezuclastinib plus sunitinib. Among the program requirements, patients must be 18 years or older, have locally advanced, unresectable or metastatic GIST, and have experienced disease progression on or intolerance to imatinib. Patients must also lack a comparable or satisfactory treatment alternative and be unable to participate in an actively enrolling bezuclastinib clinical trial. Additional eligibility criteria apply.
Importantly, patients and caregivers cannot request expanded access directly from Cogent. Patients interested in the program should talk with their treating physician, who can determine whether expanded access may be appropriate and submit a request to Cogent on the patient’s behalf. Requests are considered individually, and submission does not guarantee access.
For additional information about the Bezuclastinib Expanded Access Program (NCT06948955), patients and care partners can speak with their GIST care team and review the program information provided by Cogent Biosciences or ClinicalTrials.gov.