Exelixis announced positive topline results from the Phase 3 STELLAR-303 trial in metastatic colorectal cancer, testing its drug zanzalintinib in combination with Roche's Tecentriq versus Bayer's Regorafenib (Stivarga)125.
The trial enrolled 901 previously treated, non-MSI-high metastatic colorectal cancer patients; the zanzalintinib plus Tecentriq arm showed a statistically significant improvement in overall survival versus standard-of-care regorafenib25.
This marks the first pivotal success for zanzalintinib in colorectal cancer and supports its potential as a commercial successor to Exelixis’ flagship drug, Cabometyx23.
Analysts highlighted the result as a meaningful commercial opportunity, with the relevant U.S. peak sales for zanzalintinib estimated at $875 million2.
No new safety signals were reported, and secondary endpoints like progression-free survival and response rate are being evaluated5.
The data release boosted Exelixis’ stock price, with shares rising over 10% after the announcement45.
A subgroup analysis, especially regarding patients without liver metastases, will continue to be evaluated in final analyses35.
Sources:
1. https://ir.exelixis.com/news-releases/news-release-details/exelixis-announces-zanzalintinib-combination-immune-checkpoint
2. https://www.fiercebiotech.com/biotech/exelixis-blockbuster-hopeful-beats-bayer-drug-pivotal-cancer-trial-sending-stock-25
3. https://www.oncologypipeline.com/apexonco/exelixis-claims-next-generation-colorectal-win
4. https://seekingalpha.com/news/4460905-exelixis-jumps-on-phase-3-data-for-zanzalintinib-in-colorectal-cancer
5. https://www.nasdaq.com/articles/exelixis-zanzalintinib-improves-overall-survival-metastatic-colorectal-cancer