Exelixis announced that the Alliance for Clinical Trials in Oncology independent Data and Safety Monitoring Board, or DSMB, unanimously recommended to unblind and stop the phase 3 CABINET pivotal trial early due to an improvement in efficacy that was observed at an interim analysis. CABINET is evaluating cabozantinib compared with placebo in patients with either advanced pancreatic neuroendocrine tumors, or pNET, or advanced extra-pancreatic neuroendocrine tumors (also referred to as carcinoid tumors) who experienced progression after prior systemic therapy. Cabozantinib substantially prolonged the time without disease progression or death in both of the trial’s cohorts. CABINET is sponsored by the National Cancer Institute, or NCI, and is led by The Alliance for Clinical Trials in Oncology. Detailed findings will be presented at an upcoming medical meeting and discussed with the FDA. The safety profile of cabozantinib observed in the trial was consistent with its known safety profile, and no new safety signals were identified.
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