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Exelixis Announces Initiation of CONTACT-01 Phase 3 Pivotal Trial of Cabozantinib in Combination With Atezolizumab in Previously Treated Metastatic Non-small Cell Lung Cancer
– Initiation follows positive results from cohort 7 of phase 1b COSMIC-021 trial – – CONTACT-01 is the first of three phase 3 pivotal trials that are part of
About this update from Exelixis, Inc.
[{"type":"text","content":"\n– Initiation follows positive results from cohort 7 of phase 1b COSMIC-021 trial –\n\n\n– CONTACT-01 is the first of three phase 3 pivotal trials that are part of a previously announced clinical collaboration with Roche –\n\n ALAMEDA, Calif.--(BUSINESS WIRE)--\nExelixis, Inc. (NASDAQ: EXEL) today announced the initiation of CONTACT-01, a global phase 3 pivotal trial of cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®) in patients with metastatic non-small cell lung cancer (NSCLC) who have been previously treated with an immune checkpoint inhibitor (ICI) and platinum-containing chemotherapy. Two additional phase 3 pivotal trials in metastatic castration-resistant prostate cancer (CRPC; CONTACT-02) and renal cell carcinoma (RCC; CONTACT-03) are planned as part of the clinical trial collaboration between Exelixis and Roche.\n\n\n“Survival rates for patients with metastatic non-small cell lung cancer are low, and since more than half of these patients are diagnosed at an advanced stage, the patient community is in need of new treatment options, especially for those who progress following immunotherapy and chemotherapy,” said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. “We were pleased to see the positive results from cohort 7 of the COSMIC-021 trial further supporting the growing body of preclinical and clinical evidence that cabozantinib may promote a more immune-permissive environment potentially resulting in additive or synergistic effects with immune checkpoint inhibitors such as atezolizumab. We look forward to forthcoming findings for the combination in this disease in CONTACT-01, as well as in other difficult-to-treat cancers in planned phase 3 studies.”\n\n\nResults from the ongoing COSMIC-021 trial — a phase 1b study of cabozantinib and atezolizumab in multiple advanced solid tumors including NSCLC, CRPC and RCC — informed the design of this phase 3 pivotal trial. Initial results from the COSMIC-021 cohort of patients with advanced NSCLC who progressed after treatment with an ICI were presented at the 2020 American Society of Clinical Oncology Virtual Scientific Program.\n\n\nCONTACT-01 is a global, multicenter, randomized, phase 3, open-label study that aims to enroll approximately 350 patients. Patients will be randomized 1:1 to the e...