What is the role of avelumab 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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Answer

In 2019, the FDA approved the combination of avelumab and axitinib for the frontline treatment of patients with advanced RCC.

Approval was based on the results from the phase 3 JAVELIN Renal 101 study (n=886), in which median PFS was 13.8 months with avelumab plus axitinib, as compared with 8.4 months with sunitinib (HR, 0.69; P < 0.001). Median PFS with avelumab plus axitinib was the same regardless of whether the tumor was PD-L1–positive; with sunitinib, however, median PFS in PD-L1 positive tumors was 7.2 months. In the patients with PD-L1–positive tumors, the objective response rate was 55.2% with avelumab plus axitinib and 25.5% with sunitinib. [61]


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