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Exelixis Announces Positive Results from Phase 3 CABINET Pivotal Trial Evaluating Cabozantinib in Advanced Pancreatic and Extra-Pancreatic Neuroendocrine Tumors
– CABINET trial will be unblinded and stopped early due to a dramatic improvement in efficacy per a unanimous recommendation by The Alliance for Clinical
About this update from Exelixis, Inc.
[{"type":"text","content":"\n– CABINET trial will be unblinded and stopped early due to a dramatic improvement in efficacy per a unanimous recommendation by The Alliance for Clinical Trials in Oncology independent Data and Safety Monitoring Board –\n\n\n– Based on positive results, findings will be discussed with the U.S. Food and Drug Administration –\n\n\n ALAMEDA, Calif.--(BUSINESS WIRE)--\nExelixis, Inc. (Nasdaq: EXEL) today announced that the Alliance for Clinical Trials in Oncology independent Data and Safety Monitoring Board (DSMB) unanimously recommended to unblind and stop the phase 3 CABINET pivotal trial early due to a dramatic improvement in efficacy that was observed at an interim analysis. CABINET is evaluating cabozantinib (CABOMETYX®) compared with placebo in patients with either advanced pancreatic neuroendocrine tumors (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 (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 U.S. Food and Drug Administration (FDA).\n\n\n“As there is no standard of care for patients with advanced pancreatic or extra-pancreatic neuroendocrine tumors whose disease has progressed after prior therapy, we are pleased to see that cabozantinib improved outcomes for two additional patient populations living with advanced, difficult-to-treat cancers,” said Will Berg, M.D., Senior Vice President, Medical Affairs, Exelixis. “We are grateful for the recommendation of the Data and Safety Monitoring Board to unblind the CABINET study early due to a dramatic improvement in efficacy and look forward to discussing these findings with the U.S. Food and Drug Administration.”\n\n\nThe safety profile of cabozantinib observed in the trial was consistent with its known safety profile, and no new safety signals were identified.\n\n\n“Patients with progressive neuroendocrine tumors have limited treatment options. At present, after progression on previous therapies, the treatment path is unclear, underscoring the need for additional options for this disease that is ...