Exelixis announced today (2025‑10‑20) detailed results from the STELLAR‑303 Phase 3 trial evaluating zanzalintinib plus atezolizumab versus regorafenib in previously treated non‑MSI‑high metastatic colorectal cancer. The announcement was made at the European Society for Medical Oncology (ESMO) Congress and simultaneously published in The Lancet. The company reported a 20% reduction in the risk of death (hazard ratio 0.80, 95% CI 0.69‑0.93, P = 0.0045) and a median overall survival of 10.9 months versus 9.4 months with regorafenib.
Median follow‑up was 18.0 months, with 10.9 months overall survival for the combination and 9.4 months for regorafenib. The trial also showed a consistent overall survival benefit across key subgroups, including geographic region, RAS status, liver involvement, and prior anti‑VEGF therapy. Progression‑free survival trended in favor of the combination, with a hazard ratio of 0.68 and median PFS of 3.7 months versus 2.0 months for regorafenib.
Exelixis plans to file its first new drug application for zanzalintinib in the United States later this year, following the positive data. The company highlighted that the results support a new oral, chemotherapy‑free option for patients with metastatic colorectal cancer after standard therapies. The announcement marks a significant milestone in the company’s dual‑engine growth strategy and could expand the commercial footprint of its next‑generation tyrosine kinase inhibitor.
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