FDA News

Lenvatinib-pembrolizumab combination receives breakthrough status 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.

A multicenter, open-label, phase 1b/phase 2 study was designed to assess the safety and efficacy of the combination therapy for 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 no standard effective therapies were available.

In the phase 1b study, patients received 24 mg daily lenvatinib mesylate (Lenvima, Eisai) — a multiple receptor tyrosine kinase inhibitor — plus 200 mg of the anti-PD-1 therapy pembrolizumab (Keytruda, Merck) every 3 weeks.

In the phase 2 study, which is still underway, patients are receiving 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. 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 a press 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.

A multicenter, open-label, phase 1b/phase 2 study was designed to assess the safety and efficacy of the combination therapy for 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 no standard effective therapies were available.

In the phase 1b study, patients received 24 mg daily lenvatinib mesylate (Lenvima, Eisai) — a multiple receptor tyrosine kinase inhibitor — plus 200 mg of the anti-PD-1 therapy pembrolizumab (Keytruda, Merck) every 3 weeks.

In the phase 2 study, which is still underway, patients are receiving 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. 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 a press release.