On January 9, Eisai and Merck announced that they received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for Eisai's multiple receptor tyrosine kinase inhibitor lenvatinib (Lenvima) in combination with Merck's anti–programmed cell death protein 1 (PD-1) therapy pembrolizumab (Keytruda) for the potential treatment of patients with advanced and/or metastatic renal cell carcinoma. The combination therapy is being jointly developed by Eisai and Merck.
The designation was based on the results of the renal cell carcinoma cohort in Study 111, a multicenter, open-label phase Ib/II clinical study being carried out in the United States and the European Union to evaluate the efficacy and safety of lenvatinib in combination with pembrolizumab in subjects with selected solid tumors.
Takashi Owa, PhD, Vice President, Chief Medicine Creation Officer, Oncology Business Group, Eisai, commented: “We are encouraged that the FDA has recognized the potential of lenvatinib plus pembrolizumab for patients with advanced and/or metastatic renal cell carcinoma with the Breakthrough Therapy designation. As a human health-care company dedicated to giving our first thought to patients, we are committed to working closely with Merck and the FDA to expedite this clinical program with the hope that we may offer another important option for patients in need.”
“The FDA's Breakthrough Therapy designation for the lenvatinib and pembrolizumab combination in advanced and/or metastatic renal cell carcinoma provides us with the opportunity to accelerate our effort to bring an important potential treatment option to these patients,” said Roy Baynes, MD, PhD, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, Merck Research Laboratories.
About Study 111
Study 111 is a multicenter, open-label phase Ib/II clinical study being carried out in the United States and European Union to evaluate the efficacy and safety of lenvatinib in combination with pembrolizumab. The primary objective of phase Ib was to determine the maximum tolerated dose. Patients with unresectable solid tumors (renal cell carcinoma, endometrial cancer, non–small cell lung cancer, urothelial cancer, squamous cell head and neck cancer, and melanoma) who had disease progression after treatment with approved therapies or for which there are no standard effective therapies available were administered 24 mg of lenvatinib orally daily, as well as 200 mg of pembrolizumab intravenously every 3 weeks. Dose reductions of lenvatinib were permitted based on observed toxicity.
Phase II was conducted with patients who had select solid tumors with zero to two prior lines of systemic therapy (unless discussed with the sponsor), with a recommended dosage of 20 mg of lenvatinib daily and 200 mg of pembrolizumab every 3 weeks as determined based on the results of phase Ib. The primary endpoint of phase II was objective response rate at 24 weeks after treatment began, with select secondary endpoints including objective response rate, disease control rate, progression-free survival, and duration of response.
Currently, phase II is underway, with enrollment expanded for the endometrial cancer cohort.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.