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Exelixis Announces Enrollment Completion in Phase 3 CONTACT-01 Pivotal Trial of Cabozantinib in Combination with an Immune Checkpoint Inhibitor in Previously Treated Metastatic Non-Small Cell Lung Cancer
– Global, phase 3 pivotal trial part of ongoing clinical collaboration with Roche – ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (Nasdaq: EXEL) today
About this update from Exelixis, Inc.
[{"type":"text","content":"\n– Global, phase 3 pivotal trial part of ongoing clinical collaboration with Roche –\n\n ALAMEDA, Calif.--(BUSINESS WIRE)--\nExelixis, Inc. (Nasdaq: EXEL) today announced that enrollment is now completed for CONTACT-01, the global, phase 3 pivotal trial evaluating 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 and platinum-containing chemotherapy.\n\n“Patients with advanced non-small cell lung cancer urgently need new treatment options after disease progression following immunotherapy and chemotherapy,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. “Following promising early results in the previously treated advanced non-small cell lung cancer cohort of the phase 1b COSMIC-021 trial, we are eager to learn more about how cabozantinib in combination with atezolizumab may benefit this patient population. Completing enrollment of CONTACT-01 is an important step forward, and we look forward to sharing top-line results when the data mature.”\n\nCONTACT-01 is a global, multicenter, randomized, phase 3, open-label study that enrolled 366 patients who were randomized 1:1 to the experimental arm of cabozantinib in combination with atezolizumab and the control arm of docetaxel. The primary endpoint of the trial is overall survival. Secondary endpoints include progression-free survival, objective response rate and duration of response. Results from cohort 7 of the phase 1b COSMIC-021 trial informed the CONTACT-01 trial design. CONTACT-01 is sponsored by Roche and co-funded by Exelixis. More information about the trial is available at ClinicalTrials.gov.\n\nAbout NSCLC\n\nLung cancer is the second most common type of cancer in the U.S., with more than 235,000 new cases expected to be diagnosed in 2021.1 The disease is the leading cause of cancer-related mortality in both men and women, causing 25% of all cancer-related deaths.1 The majority (84%) of lung cancer cases are NSCLC, which mainly comprise adenocarcinoma, squamous cell carcinoma and large cell carcinoma.1,2 The five-year survival rate for patients with NSCLC is 24%, but that rate falls to just 6% for those with advanced or metastatic disease.2 More than half of lung cancer cases are diagnos...