Exelixis says new data on Cabometyx do not support sNDA filing in HCC
US biotech companies Exelixis (Nasdaq: EXEL) yesterday announced results from the final analysis of the second primary endpoint of overall survival (OS) from the Phase III COSMIC-312 trial, which evaluated Cabometyx (cabozantinib) in combination with atezolizumab versus sorafenib in patients with previously untreated advanced hepatocellular carcinoma (HCC).
Exelixis’ shares closed down 1.9% on Monday, following the announcement, and fell a further 1.3% to $20.33 pre-market today.
The final analysis showed neither improvement nor detriment in OS for cabozantinib in combination with atezolizumab versus sorafenib. Based on this outcome for OS and the rapidly evolving treatment landscape for previously untreated advanced HCC, Exelixis does not intend to submit a supplemental New Drug Application to the US Food and Drug Administration (FDA). Full results will be presented at a future medical meeting.
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