Evicenter
P&T meetings

Zanzalintinib (XL092)

Metastatic colorectal cancer

Manufacturer
Exelixis
Regulatory submission
NDA submitted December 2025
Launch
Not announced
Last updated
65 sources

Executive summary

Zanzalintinib efficacy and safety

1 evidence topic · 3 sources

Summary

STELLAR-303 randomized 901 participants. Zanzalintinib plus atezolizumab produced median overall survival of 10.9 months versus 9.4 months with regorafenib in the intention-to-treat population, with a hazard ratio of 0.80 (95% confidence interval 0.69–0.93; P=0.0045). The final analysis in participants without active liver metastases did not establish statistical significance: hazard ratio 0.83 (95% confidence interval 0.66–1.05; P=0.1185). Grade 3 or higher treatment-related adverse events occurred in 268 of 446 participants (60%) receiving the combination and 161 of 434 (37%) receiving regorafenib. Treatment-related deaths were reported in five participants (1%) and one participant (<1%), respectively.