Exelixis’ Kinase Blocker Zanzalintinib Sets New Survival Standard in Third-Line Metastatic Colorectal Cancer, Paving Way for FDA Review

Exelixis announced that its investigational kinase inhibitor, zanzalintinib, combined with Roche's Tecentriq (atezolizumab), demonstrated a statistically significant improvement in overall survival compared to regorafenib in previously treated metastatic colorectal cancer in the Phase 3 STELLAR-303 trial68.

The median overall survival was 10.9 months with the zanzalintinib and Tecentriq combination, compared to 9.4 months with regorafenib at a median follow-up of 18 months, representing a 20% reduction in risk of death4.

The study enrolled 901 patients with non-microsatellite instability-high (non-MSI-high) metastatic colorectal cancer who had received prior treatment8.

No new safety concerns were reported with the zanzalintinib combination; secondary endpoints such as progression-free survival and response rates are still being evaluated8.

This trial marks the first pivotal success for zanzalintinib in colorectal cancer, potentially setting a new standard for third-line therapy in this patient population68.

Exelixis intends to discuss these results with the FDA and other regulatory authorities regarding next steps toward potential approval8.

Sources:

4. https://www.benzinga.com/news/health-care/25/10/48305500/exelixis-stock-falls-after-phase-3-colorectal-cancer-trial-shows-mixed-results

6. https://www.biospace.com/drug-development/exelixis-beats-bayer-in-colorectal-cancer-as-zanzalintinib-delivers-first-pivotal-success

8. https://www.nasdaq.com/articles/exelixis-zanzalintinib-improves-overall-survival-metastatic-colorectal-cancer