Exelixis announces ‘positive’ results from STELLAR-303 phase 3 trial

Exelixis (EXEL) announced “positive” topline results from the STELLAR-303 phase 3 trial in which zanzalintinib in combination with atezolizumab demonstrated a statistically significant improvement in overall survival, OS, versus regorafenib in the intent-to-treat, ITT, population of patients with previously treated non-microsatellite instability-high metastatic colorectal cancer, CRC. These topline findings are from the final analysis conducted by the Independent Data Monitoring Committee of one of the dual primary endpoints of the STELLAR-303 phase 3 trial. The trial will proceed to the planned final analysis for the other dual primary endpoint of OS in patients without liver metastases. The safety profiles of zanzalintinib in combination with atezolizumab and of regorafenib were generally consistent with what has been previously observed, and no new safety signals were identified. Secondary endpoints of STELLAR-303 include progression-free survival, objective response rate and duration of response in the ITT population and in the NLM subgroup of patients. Exelixis plans to submit detailed results of STELLAR-303 for presentation at an upcoming medical conference.