Combining Immunotherapy and Targeted Therapy for Kidney Cancer 

The U.S. FDA approved the combination of lenvatinib and pembrolizumab to treat adult patients with renal cell carcinoma, the most common form of kidney cancer. 

The U.S. Food and Drug Administration (FDA) approved the combination of the molecularly targeted therapeutic lenvatinib (Lenvima) and the immunotherapeutic pembrolizumab (Keytruda) as a first-line treatment for adults with advanced renal cell carcinoma.  

The approval was based on a multicenter, open-label, randomized phase III clinical trial in 712 patients with advanced renal cell carcinoma, the most common form of kidney cancer. Half of the patients were assigned to receive lenvatinib-pembrolizumab, and the other half were assigned to receive the standard-of-care drug sunitinib. Patients receiving lenvatinib-pembrolizumab had a median progression-free survival of 23.9 months, while those receiving sunitinib had a median progression-free survival of 9.2 months. 

Pembrolizumab is an antibody-based drug in a class of cancer immunotherapeutics known as immune checkpoint inhibitors. It targets the protein PD-1 which acts as a brake on the function of immune cells called T cells. Some cancer cells exploit this brake to prevent T cells from attacking and destroying them. By targeting PD-1, pembrolizumab releases the brake to help the T cells fight cancer. 

Lenvatinib targets multiple proteins called tyrosine kinases, which promote cancer growth and progression in different ways. Some of these mechanisms include cell proliferation, changes in cell states that lead to metastasis, and the growth of the blood and lymphatic vessel networks that tumors establish to grow and survive.  

The agency’s approval means that the lenvatinib-pembrolizumab combination can be the first treatment given to adults with renal cell carcinoma, the most common form of kidney cancer. More than 76,000 people in the United States were expected to be diagnosed with kidney cancer in 2021. 

The FDA decision was rendered on August 10, 2021.