Keytruda/Lenvima CRL To Give Roche More Space In 1L HCC?

But Phase III Is Already Enrolled

Jul 10 2020

• By Ian Haydock

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Merck/Eisai face US speed bump for combo in first-line liver cancer after FDA decision and although their Phase III trial is already enrolled, completion is not due until 2022, giving time for new competitor to make its mark.

Liver cancer, CT scan upper abdomen. — US CRL For New Combo May Shape Evolving HCC Market • Source: Shutterstock

While the US Food and Drug Administration’s decision to issue a Complete Response Letter (CRL) on Merck & Co. and Eisai Co., Ltd.’s bid for accelerated approval of their Keytruda (pembrolizumab) and Lenvima (lenvatinib) combination in first-line unresectable hepatocellular carcinoma (HCC) may be a setback, the companies are already well ahead with another supporting trial in this setting.

But in the meantime, another new combo from Roche has already gained approval in the indication on the back of...

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