Business
Exelixis Announces First 100 Patients Enrolled in Phase 3 COSMIC-311 Pivotal Trial of Cabozantinib in Relapsed Radioiodine-Refractory Differentiated Thyroid Cancer
– Analysis for the co-primary endpoint of objective response rate and an interim analysis of progression-free survival expected in the second half of 2020 –
About this update from Exelixis, Inc.
[{"type":"text","content":"\n– Analysis for the co-primary endpoint of objective response rate and an interim analysis of progression-free survival expected in the second half of 2020 –\n\n ALAMEDA, Calif.--(BUSINESS WIRE)--\nExelixis, Inc. (NASDAQ: EXEL) today announced enrollment of the first 100 patients in COSMIC-311, a phase 3 pivotal trial evaluating cabozantinib (CABOMETYX®) versus placebo in patients with radioactive iodine-refractory differentiated thyroid cancer who have progressed after up to two vascular endothelial growth factor (VEGF) receptor-targeted therapies.\n\n\n“Given the encouraging clinical activity observed for cabozantinib in phase 1 and 2 trials in differentiated thyroid cancer, and the poor prognosis for patients who have progressed after prior VEGF receptor-targeting therapy, it is exciting to reach this milestone for COSMIC-311,” said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. “This brings us one step closer to a first analysis that will help us better understand cabozantinib’s potential in treating patients with this intractable form of thyroid cancer. We look forward to sharing those initial results later this year.”\n\n\nCOSMIC-311 is a multicenter, randomized, double-blind, placebo-controlled phase 3 pivotal trial that aims to enroll approximately 300 patients at 150 sites globally. Patients will be randomized in a 2:1 ratio to receive either cabozantinib 60 mg or placebo once daily. Exelixis expects to conduct an analysis in the first 100 patients for the co-primary endpoint of objective response rate, and an interim analysis of progression-free survival in the second half of 2020. Additionally, total enrollment of 300 patients is expected to be reached in the second half of 2020.\n\n\nMore information about this trial is available at ClinicalTrials.gov.\n\n\nAbout Differentiated Thyroid Cancer\n\n\nApproximately 53,000 new cases of thyroid cancer will be diagnosed in the U.S. in 2020.1 Nearly three out of four of these cases will be in women, and the disease is more commonly diagnosed at a younger age compared to most other adult cancers.1 While cancerous thyroid tumors include differentiated, medullary and anaplastic forms, differentiated thyroid tumors make up about 90 percent of cases.1 These include papillary, follicular and Hürthle cell cancer.1 Diffe...