What is the role of pembrolizumab (Keytruda) in the treatment of renal cell carcinoma (RCC)?

Updated: Feb 19, 2021
  • Author: Kush Sachdeva, MD; Chief Editor: E Jason Abel, MD  more...
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Pembrolizumab (Keytruda), a PD-1 inhibitor, gained accelerated FDA approval in April 2019 for first-line treatment of advanced renal cell carcinoma in combination with axitinib.

In the open-label Keynote-426 trial, which included 861 patients, treatment with pembrolizumab plus axitinib resulted in significantly longer overall survival and PFS, as well as a higher objective response rate, than treatment with sunitinib. The estimated percentage of patients who were alive at 12 months was 89.9% in the pembrolizumab–axitinib group and 78.3% in the sunitinib group (hazard ratio [HR] for death, 0.53; P < 0.0001). Median PFS was 15.1 months in the pembrolizumab–axitinib group and 11.1 months in the sunitinib group (HR for disease progression or death, 0.69; P < 0.001). The objective response rates with pembrolizumab–axitinib and sunitinib were 59.3% versus 35.7%, respectively (P < 0.001). The overall frequency of toxic effects was similar in the two groups. [60]  

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