FDA Grants Priority Review to Keytruda Combo as Frontline Treatment for Kidney Cancer

The Food and Drug Administration (FDA) granted a priority review to Keytruda (pembrolizumab) in combination with Inlyta (axitinib) as a frontline treatment for advanced renal cell carcinoma (RCC), according to Merck, the manufacturer of the anti-PD-1 therapy.

“Many patients with advanced renal cell carcinoma face a poor prognosis and there remains a need for new and effective treatment options in the first-line setting,” said Roger M. Perlmutter, M.D., Ph.D., president of Merck Research Laboratories, in a press release.

The new biologics license application was based on findings from the phase 3 KEYNOTE-426 trial, designed to evaluate Keytruda in combination with Inlyta compared with Sutent (sunitinib) as a frontline treatment in 861 patients with advanced RCC.

In October 2018, Merck announced the trial had met its coprimary endpoints of significant improvement in overall and progression-free survival, as well as the secondary endpoint of significantly improved objective response rate. The company also noted that safety data for Keytruda and Inlyta were consistent with earlier findings from studies of each agent.

“KEYNOTE-426 demonstrated that an anti-PD-1 combination therapy significantly improved overall survival and progression-free survival versus sunitinib in the first-line treatment of advanced renal cell carcinoma. We look forward to working with the FDA to bring this Keytruda combination to patients,” Perlmutter added.

Further data from this study will be presented at the 2019 Genitourinary Cancers Symposium in San Francisco on Feb. 16.

The application also included supporting data from the phase 1b KEYNOTE-035 trial, which showed that antitumor activity with the combination was superior to that expected from Inlyta or a PD-1/PD-L1 pathway inhibitor monotherapy in treatment-naïve patients with advanced RCC. In addition, fewer liver function test abnormalities and less fatigue were reported compared with other combinations of VEGF inhibitors and PD-1 checkpoint inhibitors, as previously reported by OncLive, a sister publication of CURE’s.

The FDA has set a target action date of June 20, 2019.