Exelixis and Ipsen announces cabozantinib in combination with an immune checkpoint inhibitor improved progression-free survival in phase 3 COSMIC-312 trial in patients with previously untreated advanced liver cancer

RCT (n=840) met one of the primary endpoints, with cabozantinib in combination with atezolizumab, demonstrating a significant improvement in progression-free survival (PFS) compared with sorafenib (HR: 0.63; 99% CI 0.44-0.91; p=0.0012) at the planned primary analysis.

SPS commentary:

A prespecified interim analysis for second primary endpoint of overall survival (OS), conducted at the same time as the primary analysis for PFS, showed a trend favouring the combination of cabozantinib and atezolizumab but did not reach statistical significance. Based on the preliminary OS data, the probability of reaching statistical significance at the time of the final analysis is low. The trial will continue as planned to the final analysis of OS; results are anticipated in early 2022.

Biospace Inc.