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Phase III COSMIC-312 trial of Cabometyx does not show clear benefits in liver cancer.- Exelixis

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Published:16th Mar 2022

Exelixis 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).

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 FDA. Full results will be presented at a future medical meeting.

COSMIC-312 is a global, multicenter, randomized, controlled phase III trial that enrolled 837 patients at 281 study centers globally. Patients were randomized approximately 2:1:1 to one of three arms: cabozantinib (40 mg) in combination with atezolizumab (n=432), sorafenib (n=217) or cabozantinib (60 mg; n=188). Data from the analysis of the primary endpoint of progression-free survival was previously reported.

Condition: Liver Cancer
Type: drug

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