The FDA granted a priority review to pembrolizumab (Keytruda) in combination with axitinib (Inlyta) 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, MD, PhD, president, Merck Research Laboratories, in a press release.
The new biologics license application was based on findings from the phase III KEYNOTE-426 trial
, designed to evaluate pembrolizumab in combination with axitinib compared with sunitinib (Sutent) 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 (OS) and progression-free survival (PFS), as well as the secondary endpoint of significantly improved objective response rate (ORR). The company also noted that safety data for pembrolizumab and axitinib 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 ASCO GU Symposium in San Francisco on Feb. 16.
The application also included supporting data from the phase Ib KEYNOTE-035 trial, which showed that antitumor activity with the combination was superior to that expected from axitinib 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 Oncology Nursing News
The FDA has set Prescription Drug User Fee Act (PDUFA) date of June 20, 2019.