- 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.
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