Exelixis announced that zanzalintinib, in combination with Roche’s checkpoint inhibitor atezolizumab (Tecentriq), achieved a significant improvement in overall survival compared to Bayer’s Stivarga (regorafenib) in a phase 3 trial (STELLAR-303) for previously treated metastatic colorectal cancer25.
The trial enrolled 901 patients and found that the zanzalintinib-containing combination improved overall survival across all randomized patients, covering a large commercial opportunity25.
The co-primary endpoint was overall survival in patients without liver metastases, but the combination also prevailed in the broader intent-to-treat population, which includes patients with liver metastases3.
No new safety signals were identified in the trial, suggesting a predictable tolerability profile for this drug combination5.
Analysts suggest that this trial success represents a meaningful commercial opportunity for Exelixis, with risk-adjusted U.S. peak sales estimates for zanzalintinib of $875 million2.
Exelixis sees zanzalintinib as the potential successor to its flagship drug Cabometyx, which faces patent expiry in 2030, with ambitions for zanzalintinib to reach $5 billion in annual sales by 20333.
Detailed clinical trial results are expected to be presented at an upcoming medical conference5.
Sources:
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
5. https://www.targetedonc.com/view/zanzalintinib-atezolizumab-improves-crc-survival-expands-tki-s-role-in-solid-tumors