Eisai’s multiple receptor tyrosine kinase inhibitor lenvatinib mesylate (Lenvima) in combination with Merck’s anti-programmed death-1 therapy pembrolizumab (Keytruda) received FDA’s breakthrough therapy designation for treatment of patients with advanced kidney cancer.
This is the second breakthrough therapy designation for lenvatinib and the 12th granted to pembrolizumab.
Lenvima/Keytruda combo helps for the treatment of patients with advanced and/or metastatic renal cell carcinoma.
This designation was based on the results of the renal cell carcinoma (RCC) cohort in Study 111, a multicenter, open-label, phase 1b/2 clinical study being carried out in the United States and the European Union.
It estimates the effectiveness and safety of the two drugs in combination in patients with selected solid tumors. Determining the maximum tolerated dose is the major objective of the phase 1b part of study 111.
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 progressed after treatment with approved therapies were administered 24 mg of lenvatinib orally daily and 200 mg of pembrolizumab intravenously every three weeks.
Based on observed toxicity, dose reductions of lenvatinib were permitted. Selected patients with solid tumors with zero to two prior lines of systemic therapy (unless discussed with the sponsor) are chosen to conduct the phase 2 part of Study 111.
They are given a recommended dosage of 20 mg of lenvatinib daily and 200 mg of pembrolizumab every three weeks as determined based on the results of the phase 1b portion of the study.
The end result of phase 2 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 2 is under way, with enrollment expanded for the endometrial cancer cohort.