Exelixis has entered into a strategic collaboration with Natera to initiate STELLAR-316, a randomized phase III trial evaluating zanzalintinib in resected stage II/III colorectal cancer patients who remain molecular residual disease–positive following definitive therapy. The trial will enroll approximately 1,200 patients across North America and Europe, using Signatera™ ctDNA testing to identify high-risk individuals with no radiographic evidence of disease. The primary endpoint is disease-free survival, with longitudinal ctDNA clearance as a key secondary endpoint. Exelixis anticipates trial initiation in mid-2026 and projects top-line readout by late 2029, targeting an addressable patient population of some 18,000 U.S. cases annually.

Building on positive outcomes from the phase III STELLAR-303 study, Exelixis filed a New Drug Application in December 2025 for zanzalintinib combined with atezolizumab in previously treated metastatic colorectal cancer. STELLAR-303 met one of its dual primary endpoints, showing a statistically significant overall survival benefit versus regorafenib, with a hazard ratio of 0.72 (95% CI: 0.60–0.87) at interim analysis. An observed median OS improvement from 9.3 to 12.9 months underpins the submission. The company expects an FDA decision in the second half of 2026, which could expand its revenue base beyond its current flagship kinase inhibitor.

Exelixis will deliver a corporate overview at the J.P. Morgan 2026 Healthcare Conference on January 12, 2026. CEO Michael Morrissey, Ph.D., will review the company’s commercial performance—highlighting $1.74 billion in Cabometyx revenue through Q3 2025, up 7.5% year-over-year—and update investors on the late-stage pipeline, including projections for zanzalintinib’s contribution to mid-term growth. A live webcast will be available via the company’s investor relations site, with replay access for 30 days.