Initiation of the STELLAR-303 phase III pivotal trial evaluating XL 092 + atezolizumab in patients with metastatic colorectal cancer
Exelixis, Inc. announced the initiation of STELLAR-303, a phase III pivotal trial evaluating XL 092 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.
XL 092 is a next-generation tyrosine kinase inhibitor (TKI) in development for multiple advanced tumor types.
STELLAR-303 is a global, multicenter, randomized phase III open-label study that will enroll approximately 600 patients with documented RAS status. Patients will be randomized 1:1 to receive either XL 092 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.
Previously 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 XL 092 in this setting. The trial is sponsored by Exelixis, and Roche is supplying atezolizumab.
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