Lenvima-Keytruda Combination Granted FDA Breakthrough Therapy for Renal Cell Carcinoma

Eisai and Merck recently announced that the FDA granted breakthrough therapy designation to an immunotherapy combination of lenvatinib mesylate (Lenvima) plus pembrolizumab (Keytruda) for patients with renal cell carcinoma, according to a company press release.

Lenvatinib mesylate is a multiple receptor tyrosine kinase inhibitor that previously received FDA breakthrough designation. Merck’s pembrolizumab is a PD-1 inhibitor that has received 11 previous breakthrough designations, according to the release.

“We are encouraged that the FDA has recognized the potential of Lenvima plus Keytruda for patients with advanced and/or metastatic renal cell carcinoma with the breakthrough therapy designation” said Dr Takashi Owa, chief medicine creation officer, Oncology Business Group, Eisai Co. “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 novel designations were based on positive findings from the phase 1b/2 Study 111, which included patients with unresectable solid tumors, including renal cell carcinoma, endometrial cancer, non-small cell lung cancer, urothelial cancer, squamous cell head and neck cancer, and melanoma. Patients received lenvatinib mesylate 24-mg orally per day and pembrolizumab 200-mg infusion every 3 weeks.

The primary endpoint of the phase 1b portion of the trial was to determine the maximum tolerated dose of the combination therapy and the primary endpoint of the phase 2 portion was objective response rate at 24 weeks, according to the release. Secondary endpoints included objective response rate, disease control rate, progression-free survival, and duration of response.

The study results suggested that the combination of lenavatinib mesylate plus pembrolizumab would be beneficial for patients with renal cell carcinoma, according to the release.

“The FDA's breakthrough therapy designation for the Lenvima and Keytruda 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. “We remain committed to understanding the full potential of Keytruda across cancers and treatment settings, and our collaboration with Eisai is one of the many ways we are executing on this commitment to helping more patients.”