The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Keytruda (pembrolizumab; Merck), in combination with Lenvima (lenvatinib; Eisai), for the first-line treatment of patients with advanced unresectable hepatocellular carcinoma (HCC) not amenable to locoregional treatment.
The Breakthrough Therapy designation was based on updated interim results from the multicenter, open-label, phase 1b KEYNOTE-524/Study 116 trial which is evaluating the safety and efficacy of the combination in patients with unresectable HCC, Barcelona Clinic Liver Cancer stage B (not eligible for transarterial chemoembolization) or C, Child-Pugh class A, and ECOG performance status of 0 or 1.
“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,” said Dr Jonathan Cheng, Vice President, Oncology Clinical Research, Merck Research Laboratories. “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.”
Keytruda, a programmed death receptor-1 (PD-1)-blocking antibody, is currently approved for the treatment of hepatocellular carcinoma in patients previously treated with sorafenib, non-small cell lung cancer, small cell lung cancer, melanoma, head and neck squamous cell cancer, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, cervical cancer, merkel cell carcinoma, and renal cell carcinoma.
Lenvima, a kinase inhibitor, is currently approved for the first-line treatment of unresectable hepatocellular carcinoma; it is also approved for the treatment of renal cell carcinoma and thyroid cancer.