FDA grants breakthrough therapy designation to Keytruda-Lenvima combination for hepatocellular carcinoma

The FDA granted breakthrough therapy
designation to pembrolizumab in combination with lenvatinib as first-line
treatment for patients with advanced unresectable hepatocellular carcinoma who
are not able to receive locoregional treatment.

This is the third breakthrough therapy
designation granted by FDA for pembrolizumab (Keytruda, Merck) — an anti-PD-1
therapy — and lenvatinib (Lenvima, Eisai), a multiple receptor tyrosine kinase

“As part of our ongoing collaboration with
Eisai, we are committed to evaluating the potential of Keytruda plus Lenvima
across a number of different types of cancer,” Jonathan Cheng, MD, vice
president for oncology clinical research at Merck Research Laboratories, said
in a press release. “With this breakthrough therapy designation from the FDA,
we look forward to working with Eisai to potentially build upon our existing
indications for this difficult-to-treat cancer, so that we can help patients
through a combination approach.”

The agency based the HCC breakthrough therapy
designation on interim results from the phase 1B KEYNOTE-524/Study 116,
presented at this year’s American Association for Cancer Research Annual

The multicenter, open-label, single-arm study
included patients with unresectable HCC who had Barcelona Clinic Liver Cancer
stage B or C disease, Child-Pugh class A disease, and ECOG performance status
of 0 or 1.

Researchers assessed the efficacy and safety
of pembrolizumab — dosed at 200 mg via IV every 3 weeks — and lenvatinib, dosed
at 12 mg daily for patients who weighed 60 kg or more, or 8 mg per day for
patients who weighed less than 60 kg.

Safety and tolerability served as primary
endpoints. OS, PFS, objective response rate and time to progression served as
secondary endpoints.

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