Exelixis Shares Drop On Mixed Results For Cabometyx Combo In Early Liver Cancer

Exelixis Inc EXEL and Ipsen IPSEY have announced mixed interim results from the COSMIC-312 Phase 3 trial evaluating cabozantinib (Cabometyx) in combination with Roche Holding AG's Tecentriq (atezolizumab) versus Bayer AG's BAYRY sorafenib in previously untreated advanced hepatocellular carcinoma patients.
Despite failing a key primary endpoint, the company moves at full speed toward a final readout and a potential label expansion.
Cabometyx and Tecentriq reduced the risk of disease progression or death in hepatocellular carcinoma (HCC) patients by 37% compared with sorafenib.
However, it failed to achieve a statistically significant improvement in overall survival at the interim analysis. The company says the probability of hitting the endpoint in time for the final analysis is low.
Nevertheless, the COSMIC-312 study will continue as planned to the final analysis in OS, with a readout expected in early 2022.
The safety data for combo treatment was consistent with the known safety profiles of Cabometyx and Tecentriq, with no new safety signals identified, Exelixis announced.
Price Action: EXEL shares are down 12.7% at $20.45 during the premarket session on the last check Monday.