The FDA has approved the combination of Merck’s Keytruda (pembrolizumab) and Eisai’s Lenvima (lenvatinib) for the first-line treatment of adult patients with advanced renal cell carcinoma.

The approval was based on results of a pivotal phase 3 clinical trial in which the combination of the two drugs showed a statistically significant advantage over Pfizer’s Sutent (sunitinib) in progression-free survival, overall survival and the objective response rate.

Keytruda plus Lenvima reduced the risk of disease progression or death by 61 percent, with a median progression-free survival of 23.9 months vs. 9.2 months for sunitinib.

A monoclonal antibody, Keytruda is an anti-PD-1 therapy that bolsters the immune system’s ability to identify and attack tumor cells.