FDA has granted the combination of pembrolizumab and lenvatinib the designation of breakthrough therapy for the treatment of metastatic renal cell carcinoma (RCC). Pembrolizumab is a PD-1 inhibitor and lenvatinib a VEGF/FGF inhibitor. The designation was based on a multicenter cohort study of RCC patients in which 63.3% patients responded to the therapy. In phase 1b, patients received 24 mg of lenvatinib and 200 mg of pembrolizumab for three weeks.

In phase 2 trials, which are still underway, patients are receiving 20 mg of lenvatinib with 200 mg of pembrolizumab for three weeks. The response rate, disease control rate and duration of response rate are being studied. If phase 2 trials show an equally good response, this combination therapy could hold promise for the treatment of solid tumors, RCC as well as other forms of cancer. Reference: Lenvatinib-pembrolizumab combination receives…