With Phase III Failure, Exelixis Drops First-Line Liver Cancer Plans For Cabometyx

While a combo of Cabometyx and Roche’s Tecentriq earlier demonstrated a progression-free survival benefit compared to Nexavar, a subsequent readout showed no overall survival benefit.

Exelixis needs new strategy
Exelixis needs a new strategy in first-line liver cancer after Phase III miss • Source: Alamy

Exelixis, Inc. called it quits on trying to bring multi-kinase inhibitor Cabometyx into first-line hepatocellular carcinoma (HCC), after the Phase III COSMIC-312 combination trial failed to yield an overall survival benefit in previously untreated HCC. The company said the survival readout showed “neither improvement nor detriment” and indicated that it would not go ahead with a planned supplemental filing, also citing the “rapidly evolving treatment landscape” as further rationale for the decision.

The 14 March announcement included no numerical data for overall survival (OS) or any other endpoints in the 837-patient, three-arm trial, which tested Cabometyx (cabozantinib) as monotherapy and in combination with Roche Holding AG’s PD-L1 inhibitor Tecentriq (atezolizumab) against Bayer AG’s Nexavar (sorafenib)

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