Exelixis Will Not Pursue Untreated Liver Cancer Indication For Cabometyx Combo Therapy

Exelixis Inc EXEL announced results from the final analysis of the second primary endpoint of overall survival (OS) from the phase 3 COSMIC-312 trial of Cabometyx (cabozantinib) plus atezolizumab versus sorafenib in untreated hepatocellular carcinoma (HCC).

• The final analysis showed neither improvement nor detriment in OS for cabozantinib/atezolizumab combo versus sorafenib.
• Bayer AG's BAYRY sorafenib is marketed as Nexavar and Roche Holdings AG's RHHBY atezolizumab as Tecentriq.
• Based on this outcome for OS, Exelixis will not submit a supplemental marketing application to the FDA. 
• Data from the analysis of the primary endpoint of progression-free survival was previously reported. The primary analysis showed that the primary endpoint of progression-free survival (PFS) was met.
• Cabozantinib plus atezolizumab significantly reduced the risk of disease progression or death by 37% compared with sorafenib.
• Median PFS was 6.8 months for cabozantinib combined with atezolizumab (n=250) versus 4.2 months for sorafenib (n=122).
• Exelixis is sponsoring COSMIC-312, and Ipsen SA IPSEY is co-funding the trial. 
• Price Action: EXEL shares closed 1.91% lower at $20.59 on Monday.