What is the efficacy of nivolumab (Opdivo) 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 2018, the FDA approved nivolumab plus ipilimumab for intermediate- and poor-risk patients with previously untreated advanced RCC. The combination of nivolumab with ipilimumab yielded significantly higher overall survival and objective response rates, compared with sunitinib, in the phase 3 CheckMate 214 trial. At a median follow-up of 25.2 months, the 18-month overall survival rate was 75% (95% confidence interval [CI], 70-78%) with nivolumab plus ipilimumab (n=425), compared with 60% (95% CI, 55-65%) with sunitinib (n=422); the median overall survival was not reached with nivolumab plus ipilimumab versus 26.0 months with sunitinib (hazard ratio for death, 0.63; P < 0.001). The objective response rate was 42% versus 27% (P < 0.001), and the complete response rate was 9% versus 1%. [50]

In February 2021, FDA also approved nivolumab plus cabozantinib for first-line treatment of advanced RCC. Approval was based on preliminary data from the phase 3 CheckMate-9ER trial, which randomized patients (n=651) with previously untreated advanced or metastatic RCC with clear cell histology at any risks to received either nivolumab plus cabozantinib or sunitinib. Nivolumab plus cabozantinib-treated arm had a higher median PFS (16.6 months [95% CI:12.5-24.9]) compare to the sunitinib-treated arm (8.3 months [95% CI: 7-9.7]). Median overall survival was not reached in either arm. The nivolumab plus cabozantinib-treated arm also reduced the risk of death by 40% compare to sunitinib-treated arm. [51]


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