Exelixis Announces Final Results from Phase 3 Pivotal CABINET Study Evaluating Cabozantinib in Advanced Neuroendocrine Tumors Presented at ESMO 2024 and Published in New England Journal of Medicine

– Cabozantinib continues to demonstrate a significant improvement in progression-free survival versus placebo in patients with advanced neuroendocrine tumors, including across key subgroups –

– Findings were the basis for the supplemental New Drug Application filed with the U.S. Food and Drug Administration for cabozantinib for advanced neuroendocrine tumors –

ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (Nasdaq: EXEL) today announced updated and final data from CABINET, a phase 3 pivotal trial evaluating cabozantinib (CABOMETYX®) versus placebo in two cohorts of patients with previously treated neuroendocrine tumors: one cohort with advanced pancreatic neuroendocrine tumors (pNET) and one cohort with advanced extra-pancreatic NET (epNET). These data are being presented today at the 2024 European Society for Medical Oncology Congress (ESMO 2024) during the Proffered Paper Session: NETs and Endocrine Tumours at 2:45 p.m. CET and were simultaneously published in the New England Journal of Medicine (NEJM).

“The phase 3 CABINET study, which was conducted through the National Cancer Institute's National Clinical Trials Network, reflects real-world clinical practice in that it enrolled a wide and heterogeneous range of patients regardless of primary tumor site, grade, somatostatin receptor expression and functional status,” said Jennifer Chan, M.D., M.P.H., study chair for the CABINET trial, Clinical Director of the Gastrointestinal Cancer Center and Director of the Program in Carcinoid and Neuroendocrine Tumors at Dana-Farber Cancer Institute. “I’m encouraged by these final results showing that cabozantinib provided a clinically meaningful treatment benefit for patients with previously treated advanced neuroendocrine tumors, including across all major clinical subgroups. The findings suggest that cabozantinib has the potential to become a new standard of care for these patients greatly in need of new treatment options.”

The final results from the CABINET study presented today at ESMO and published in NEJM demonstrate continued improvement with cabozantinib in the primary endpoint of progression-free survival (PFS) by blinded independent central review (BICR) through the data cutoff of August 24, 2023. In the pNET cohort (n=95), at a median follow-up of 13.8 months, the hazard ratio (HR) was 0.23 (95% confidence interval [CI]: 0.12-0.42; p