Exelixis, Inc. (EXEL) on Monday reported final analysis results from the phase 3 STELLAR-303 trial evaluating zanzalintinib in combination with Roche's Tecentriq versus regorafenib in previously treated non-microsatellite instability (MSI)-high metastatic colorectal cancer.
In the STELLAR-303 trial, patients were randomized to receive either zanzalintinib plus Tecentriq or regorafenib. The study's dual primary endpoints were overall survival in the intention-to-treat population and in the subgroup of patients without active liver metastases (NLM).
Results from the final analysis of overall survival in the NLM subgroup showed a non-statistically significant trend favoring the zanzalintinib-Tecentriq combination. Median overall survival was 15.9 months for patients receiving the combination therapy, compared with 12.7 months for those treated with regorafenib.
The safety profile of the combination in the NLM subgroup was consistent with previous findings, and no new safety signals were identified.
Exelixis previously reported that STELLAR-303 met its other primary endpoint, demonstrating a statistically significant improvement in overall survival in the intention-to-treat population, which included all randomized patients regardless of liver metastasis status.
In February 2026, the U.S. Food and Drug Administration accepted Exelixis' New Drug Application for zanzalintinib in combination with Tecentriq for previously treated metastatic colorectal cancer and assigned a target action date of December 3, 2026.
Exelixis shares were up nearly 1% in pre-market trading after closing at $51.91 on Thursday.
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