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Exelixis Announces Enrollment Completion in Phase 3 COSMIC-313 Pivotal Trial of Cabozantinib in Combination with Nivolumab and Ipilimumab Versus Nivolumab and Ipilimumab in Previously Untreated Advanced Renal Cell Carcinoma
ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (Nasdaq: EXEL) today announced that COSMIC-313, the phase 3 pivotal trial evaluating the combination of
About this update from Exelixis, Inc.
[{"type":"text","content":" ALAMEDA, Calif.--(BUSINESS WIRE)--\nExelixis, Inc. (Nasdaq: EXEL) today announced that COSMIC-313, the phase 3 pivotal trial evaluating the combination of cabozantinib (CABOMETYX®), nivolumab (OPDIVO®) and ipilimumab (YERVOY®) versus the combination of nivolumab and ipilimumab in patients with previously untreated advanced intermediate- or poor-risk renal cell carcinoma (RCC), has completed enrollment. The primary endpoint of the trial is progression-free survival, and additional endpoints include overall survival and objective response rate.\n\n“Following the promising final results of a phase 1b trial evaluating this triplet combination in advanced genitourinary tumors, this milestone in the phase 3 pivotal trial brings us a step closer to understanding whether cabozantinib in combination with nivolumab and ipilimumab may improve outcomes for patients with previously untreated advanced kidney cancer,” said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. “We look forward to sharing initial results from the event-driven analysis of COSMIC-313 when available and to learning more about the potential of cabozantinib in combination with immunotherapies.”\n\nCOSMIC-313 is a multicenter, randomized, double-blind, controlled phase 3 pivotal trial that enrolled approximately 840 patients at 180 sites globally. Patients were randomized 1:1 to receive cabozantinib plus nivolumab and ipilimumab or matching placebo plus nivolumab and ipilimumab. The design of COSMIC-313 was informed by the results of the CheckMate -214 trial that supported regulatory approval of nivolumab in combination with ipilimumab for the first-line treatment of patients with intermediate- and poor-risk RCC, and by results from the phase 1b study of cabozantinib in combination with nivolumab with or without ipilimumab in patients with relapsed or refractory metastatic genitourinary cancers, including RCC. Final results from that phase 1b trial were presented during the 2021 American Society of Clinical Oncology’s Genitourinary Cancers Symposium.\n\nBristol Myers Squibb is providing nivolumab and ipilimumab for use in this trial.\n\nMore information about this trial is available at ClinicalTrials.gov.\n\nAbout RCC\nThe American Cancer Society’s 2021 statistics cite kidney cancer as among the top ten most comm...