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.
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