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FDA Grants Breakthrough Therapy Designation for Combination Therapy for Advanced Kidney Cancer

By: Sarah Jackson
Posted: Wednesday, January 10, 2018

On January 9, 2018, the U.S. Food and Drug Administration granted Breakthrough Therapy designation to Eisai’s multiple receptor tyrosine kinase inhibitor lenvatinib (Lenvima) in combination with Merck’s anti–programmed cell death protein 1 therapy pembrolizumab (Keytruda) for the potential treatment of patients with advanced and/or metastatic renal cell carcinoma (RCC).

This Breakthrough Therapy designation was based on the results of the RCC cohort in Study 111, a multicenter, open-label phase Ib/II clinical trial being conducted across the United States and the European Union to evaluate the efficacy and safety of lenvatinib in combination with pembrolizumab in patients with selected solid tumors. The primary endpoint of the phase II part of the study 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.

The combination of lenvatinib and everolimus is approved for treatment of patients with advanced RCC after one prior antiangiogenic therapy.  The most common adverse reactions observed in patients treated with lenvatinib plus everolimus were diarrhea, fatigue, arthralgia/myalgia, decreased appetite, and vomiting.