XL092 with atezolizumab - (STELLAR-303)

June 2026: Exelixis, Inc. (NASDAQ: EXEL) reported final overall survival (OS) results for the dual primary endpoint in the non–active liver metastases (NLM) subgroup from the Phase 3 STELLAR-303 trial (NCT05425940) in previously treated non–MSI-high metastatic colorectal cancer (mCRC). Zanzalintinib plus atezolizumab (Tecentriq) showed a non-statistically significant OS trend vs regorafenib in the NLM subgroup (stratified HR 0.83; 95% CI 0.66–1.05; P=0.1185), with median OS 15.9 months vs 12.7 months, respectively. Safety in the NLM subgroup was consistent with prior reporting in the intention-to-treat (ITT) population and no new safety signals were identified.

The company reiterated that STELLAR-303 previously met the other dual primary endpoint, showing a statistically significant OS improvement in the ITT population; those ITT data were presented at the 2025 ESMO Congress and published in The Lancet.

Regulatory catalyst: In February 2026, the FDA accepted Exelixis’ NDA for zanzalintinib + atezolizumab for previously treated mCRC (after fluoropyrimidine/oxaliplatin/irinotecan and, if RAS wild-type, anti-EGFR therapy) and set a PDUFA target action date of December 3, 2026. Detailed NLM subgroup findings will be submitted to an upcoming medical conference.