FDA OKs Pembrolizumab Combo Therapy for Advanced Renal Cell Carcinoma


This is the first indication for pembrolizumab (Keytruda, Merck) in advanced renal cell carcinoma.

Pembrolizumab (Keytruda, Merck) has received FDA approval as a first-line treatment in combination with axitinib (Inlyta) for patients with advanced renal cell carcinoma (RCC), making it the first indication for pembrolizumab in this patient population, according to a press release.

The approval is based on data from the KEYNOTE-426 clinical trial, which evaluated pembrolizumab in combination with axitinib in 861 patients who had not received systemic therapy for advanced RCC.

For the trial, patients were randomized to receive either pembrolizumab 200 mg intravenously every 3 weeks up to 24 months with axitinib 5 mg orally, twice daily, or sunitinib 50 mg orally, once daily for 4 weeks and then off treatment for 2 weeks.

Key data from the study showed:

  • Pembrolizumab plus axitinib reduced the risk of death by 47% compared with sunitinib [HR=0.69 [95% Cl, 0.57-0.85]; p=0.0001].
  • With a median follow-up of 12.8 months, overall survival (OS) was significantly improved in patients who received the combination treatment compared with sunitinib [HR=0.53 [95% Cl, 0.38=0.74]; p<0.0001].
  • Estimated 12-month OS rates were 90% [95% Cl, 86-92] with the combination treatment versus 78% [95% Cl, 74-82] with sunitinib.
  • Median progression-free survival (PFS) was 15.1 months [95% Cl, 12.6-17.7] in patients receiving the pembrolizumab plus axitinib combination versus 11.1 months [95% Cl, 8.7-12.5] with sunitinib.
  • The overall response rate (ORR) was 59% for patients who received pembrolizumab plus axitinib [95% CI, 54-64] and 36% for those who received sunitinib [95% Cl, 31-40] [p<0.0001].

Consistent results were observed across pre-specified subgroups, IMDC risk categories, and PD-L1 tumor expression status, according to the study.

“Given the aggressive nature of the disease, many patients with advanced renal cell carcinoma need additional treatment options that can help improve survival outcomes,” Brian Rini, MD, medical oncologist at Cleveland Clinic Cancer Center and professor of medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, said in a statement. “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.”

According to Merck, pembrolizumab is the first anti-PD-1 therapy approved by the FDA as part of a combination regimen that significantly improved OS, PFS, and ORR versus sunitinib in patients with advanced RCC.


FDA Approves Merck’s Keytruda (pembrolizumab) in Combination With Inlyta (axitinib) as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma (RCC) [news release]. Merck. https://www.mrknewsroom.com/news-release/prescription-medicine-news/fda-approves-mercks-keytruda-pembrolizumab-combination-inlyt. Accessed April 22, 2019.

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