Pembrolizumab (Keytruda) has received approval from the FDA in combination with axitinib (Inlyta) for the frontline treatment of patients with advanced renal cell carcinoma (RCC), based on phase III findings from the KEYNOTE-426 trial.1
In findings from the trial, the frontline combination significantly improved overall response rates (ORRs), progression-free, and overall survival (OS) compared with sunitinib (Sutent) in patients with advanced RCC, making it the first anti–PD-1 therapy approved as part of a combination regimen to do so in this patient population. Moreover, data showed that pembrolizumab/axitinib led to a 47% reduction in the risk of death versus sunitinib (HR, 0.53; 95% CI, 0.38-0.74; P <.0001).2
“This represents a new treatment option for patients with advanced renal cell carcinoma, who will now have access to Keytruda as part of a first-line combination regimen,” said Scot Ebbinghaus, MD, vice president, clinical research, Merck Research Laboratories, the developer of pembrolizumab. “Today’s approval reflects Merck’s commitment to patients with cancer and further supports the use of KEYTRUDA to help improve survival outcomes for patients with advanced renal cell carcinoma.”
The open-label KEYNOTE-426 study (NCT02853331) included 861 patients with newly diagnosed or recurrent stage IV clear cell RCC who were randomized 1:1 to receive pembrolizumab at 200 mg intravenously every 3 weeks for up to 35 cycles plus axitinib at 5 mg orally twice daily or sunitinib at 50 mg orally once daily for the first 4 weeks of each 6-week cycle. Treatment was administered until disease progression, unacceptable toxicity, or if patients dropped out of the trial.