FDA News

FDA grants breakthrough therapy designation to Lenvima plus Keytruda for renal cell carcinoma

The FDA granted breakthrough therapy designation to lenvatinib mesylate in combination with pembrolizumab for the treatment of patients with advanced or metastatic renal cell carcinoma, according to a joint release from the agents’ manufacturers.

This is the second breakthrough therapy designation for lenvatinib (Lenvima, Eisai) — a multiple receptor tyrosine kinase inhibitor — and the twelfth for pembrolizumab (Keytruda, Merck) — an anti-PD-1 therapy.

The combination is being jointly developed by both manufacturers.

The FDA based the breakthrough therapy designation on results from the renal cell carcinoma cohort of the multicenter, open-label phase 1b/2 Study 111, which assessed the safety and efficacy of the combination therapy in patients with selected solid tumors — renal cell carcinoma, endometrial cancer, non-small cell lung cancer, urothelial cancer, squamous cell head and neck cancer, and melanoma — who progressed after treatment with approved therapies or for whom there were no standard effective therapies available.

Investigators administered patients 24 mg lenvatinib mesylate daily plus 200 mg pembrolizumab every 3 weeks in the phase 1b study.

In the phase 2 study, patients received 20 mg lenvatinib mesylate daily in combination with 200 mg pembrolizumab every 3 weeks.

Objective response rate at 24 weeks serves as the primary endpoint of the phase 2 study, which is currently underway. Secondary endpoints include disease control rate, PFS and duration of response.

“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,” Roy Baynes, MD, PhD, senior vice president and head of global clinical development and chief medical officer of Merck Research Laboratories, said in the release.

The FDA granted breakthrough therapy designation to lenvatinib mesylate in combination with pembrolizumab for the treatment of patients with advanced or metastatic renal cell carcinoma, according to a joint release from the agents’ manufacturers.

This is the second breakthrough therapy designation for lenvatinib (Lenvima, Eisai) — a multiple receptor tyrosine kinase inhibitor — and the twelfth for pembrolizumab (Keytruda, Merck) — an anti-PD-1 therapy.

The combination is being jointly developed by both manufacturers.

The FDA based the breakthrough therapy designation on results from the renal cell carcinoma cohort of the multicenter, open-label phase 1b/2 Study 111, which assessed the safety and efficacy of the combination therapy in patients with selected solid tumors — renal cell carcinoma, endometrial cancer, non-small cell lung cancer, urothelial cancer, squamous cell head and neck cancer, and melanoma — who progressed after treatment with approved therapies or for whom there were no standard effective therapies available.

Investigators administered patients 24 mg lenvatinib mesylate daily plus 200 mg pembrolizumab every 3 weeks in the phase 1b study.

In the phase 2 study, patients received 20 mg lenvatinib mesylate daily in combination with 200 mg pembrolizumab every 3 weeks.

Objective response rate at 24 weeks serves as the primary endpoint of the phase 2 study, which is currently underway. Secondary endpoints include disease control rate, PFS and duration of response.

“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,” Roy Baynes, MD, PhD, senior vice president and head of global clinical development and chief medical officer of Merck Research Laboratories, said in the release.