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Exelixis Announces Initiation of the STELLAR-303 Phase 3 Pivotal Trial Evaluating XL092 in Patients with Metastatic Colorectal Cancer
– STELLAR-303 is the first phase 3 pivotal trial evaluating XL092, a next-generation oral tyrosine kinase inhibitor – ALAMEDA, Calif.--(BUSINESS WIRE)--
About this update from Exelixis, Inc.
[{"type":"text","content":"\n– STELLAR-303 is the first phase 3 pivotal trial evaluating XL092, a next-generation oral tyrosine kinase inhibitor –\n\n ALAMEDA, Calif.--(BUSINESS WIRE)--\nExelixis, Inc. (Nasdaq: EXEL) today announced the initiation of STELLAR-303, a phase 3 pivotal trial evaluating XL092 in combination with atezolizumab versus regorafenib in patients with metastatic colorectal cancer (CRC) that is not microsatellite instability-high or mismatch repair-deficient, who have progressed after or are intolerant to the standard of care therapy. XL092 is a next-generation tyrosine kinase inhibitor (TKI) in development for multiple advanced tumor types.\n\n“There is a significant need for new treatment options for the majority of metastatic CRC patients, who do not have microsatellite instability-high or mismatch-repair deficient disease and whose tumors do not respond to immunotherapy alone,” said Vicki L. Goodman, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis. “Following recent promising data evaluating cabozantinib in combination with immunotherapies in colorectal cancer, we are thrilled to initiate our first phase 3 pivotal trial for XL092, our next-generation tyrosine kinase inhibitor. We look forward to learning more about how XL092 in combination with atezolizumab may benefit patients with metastatic colorectal cancer.”\n\nSTELLAR-303 is a global, multicenter, randomized phase 3 open-label study that will enroll approximately 600 patients with documented RAS status. Patients will be randomized 1:1 to receive either XL092 in combination with atezolizumab or regorafenib. The primary objective of the study is to evaluate the efficacy of the combination in patients with RAS wild-type disease; exploratory endpoints include examining efficacy in those with RAS-mutated disease. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, objective response rate and duration of response per Response Evaluation Criteria in Solid Tumors version 1.1 as assessed by the investigator.\n\nPreviously announced results from two studies of cabozantinib in combination with immunotherapies for the treatment of advanced CRC supported Exelixis’ decision to pursue clinical development of XL092 in this setting. The trial is sponsored by Exelixis, and Roche is supplying ...