The FDA on Friday approved pembrolizumab, used in combination with axitinib, for the first-line treatment of advanced renal cell carcinoma (RCC).

The agency based its approval on findings from the phase 3 KEYNOTE-426 trial, which demonstrated significant improvements in overall survival and progression-free survival (PFS) as well as objective response rate (ORR) among patients with advanced RCC who received pembrolizumab plus axitinib compared with those treated with sunitinib.

Pembrolizumab, marketed as KEYTRUDA by Merck, is a monoclonal antibody that binds to the programmed death 1 (PD-1) receptor on the surface of cells; axitinib is a tyrosine kinase inhibitor.

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The KEYNOTE trial included 861 patients with advanced RCC who had not yet received systemic therapy. Investigators randomly assigned 432 patient to receive pembrolizumab plus axitinib and 429 to receive sunitinib. The median follow-up time was 12.8 months. The combined therapy was associated with a 47% decreased risk of death and 31% decreased risk of disease progression or death compared with sunitinib. The ORR was 59% among patients who received pembrolizumab plus axitinib compared with 36% in the sunitinib arm.

“Pembrolizumab in combination with axitinib offers an important new therapeutic option for physicians to consider when approaching initial treatment for patients newly diagnosed with advanced renal cell carcinoma,” Brian I. Rini, MD, a medical oncologist at Cleveland Clinic and a KEYNOTE-426 investigator, said in a Merck news release.


FDA approves Merck’s KEYTRUDA ® (pembrolizumab in combination with Inlyta ® (axitinib as first-line treatment for patients with advanced renal cell carcinoma (RCC).

This article originally appeared on Renal and Urology News