FDA Grants Priority Review to Keytruda, Inlyta Combo for Advanced Kidney Cancer


The sBLA is based on data showing significant improvement in overall survival and progression-free survival in patients with advanced renal cell carcinoma.

Officials with the FDA have granted Priority Review to Merck’s supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda) for use in combination with axitinib (Inlyta, Pfizer) as first-line treatment for advanced renal cell carcinoma (RCC), according to a press release.

In 2018, there were approximately 403,000 cases of kidney cancer diagnosed worldwide and approximately 175,000 deaths from the disease.

The sBLA is based on data from the phase 3 KEYNOTE-426 trial, which studied pembrolizumab in combination with axitinib compared with sunitinib in patients with advanced RCC. For the trial, 861 patients were randomly assigned to receive pembrolizumab 200 mg intravenously every 3 weeks plus axitinib 5 mg orally twice daily for up to 24 months, or sunitinib 50 mg orally once daily for 4 weeks followed by no treatment for 2 weeks, continuously. The researchers evaluated progression-free survival (PFS) at 12, 18, and 24 months and overall survival (OS) at 12, 18, and 24 months.

Compared with sunitinib, the combination significantly improved OS and PFS as a first-line treatment, according to the study. OS, PFS, and ORR were consistent regardless of PD-L1 expression and across all risk groups.

According to the findings, at a median follow-up of 12.8 months:

  • The combination therapy was associated with a 47% reduction in the risk of death compared with sunitinib (hazard ratio [HR]=0.53).
  • The 12-month OS rate was 89.9% in the combination group versus 78.3% in the sunitinib group.
  • Patients treated with pembrolizumab plus axitinib lived a median of 15.1 months without disease progression versus 11.1 months with sunitinib.
  • The study showed that the ORR was 59.3% with the combination versus 35.7% with sunitinib.
  • Duration of response was longer in patients treated with combination therapy, with a median not yet reached versus 15.2 months with sunitinib.

“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,” Dr Roger M. Perlmutter, president of Merck Research Laboratories, said in a statement. “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.”

The sBLA also included supporting data from the phase 1b KEYNOTE-035 trial. In this study, pembrolizumab plus axitinib had a manageable safety profile and a high response rate (73%) among patients with metastatic RCC.

A Prescription Drug User Fee Act date has been set for June 20, 2019, according to Merck.


FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for Keytruda (pembrolizumab) in Combination with Inlyta (axitinib) as First-Line Treatment for Advanced Renal Cell Carcinoma [news release]. Merck. https://www.mrknewsroom.com/news-release/oncology/fda-grants-priority-review-mercks-supplemental-biologics-license-application-2. Accessed February 15, 2019.

2019 GU Cancers Symposium: KEYNOTE-426: Pembrolizumab Plus Axitinib vs Sunitinib in Advanced Renal Cell Carcinoma. American Society of Clinical Oncology. http://www.ascopost.com/News/59740. Accessed February 15, 2019.

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