The following article features coverage from the 2019 Genitourinary Cancers Symposium. Click here to read more of Cancer Therapy Advisor‘s conference coverage.

Additional follow-up of the phase 3 CheckMate 214 trial confirms the survival benefit of nivolumab plus ipilimumab over sunitinib as a first-line treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC), investigators reported at the 2019 Genitourinary Cancers Symposium.1

The CheckMate 214 trial compared the treatments in 1096 intention-to-treat patients with advanced RCC randomly assigned to receive nivolumab, a programmed death 1 (PD-1) immune checkpoint inhibitor antibody, plus ipilimumab, an anticytotoxic T-lymphocyte antigen-4 antibody (550 patients) or sunitinib, a vascular endothelial growth factor receptor tyrosine kinase inhibitor (546 patients).

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In the primary analysis, intermediate- and poor-risk patients had a minimum follow-up of 17.5 months. The 18-month overall survival rate was 75% for the nivolumab-ipilimumab group and 60% for sunitinib recipients.2 The nivolumab-ipilimumab group had a significant 37% decreased risk of death compared with the sunitinib-treated patients (P <.001). The objective response rate (ORR) was 42% and 27%, respectively.

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For the new analysis, patients had a minimum follow-up of 30 months, Nizar M. Tannir, MD, FACP, of the University of Texas MD Anderson Cancer Center in Houston, and colleagues reported. For patients with intermediate- and poor-risk disease, those who were treated with nivolumab plus ipilimumab had a significant 34% decreased risk of death compared with sunitinib-treated patients (hazard ratio [HR] 0.66; 95% confidence interval [CI], 0.54–0.80]; P <.0001).

In addition, the overall survival rate at 24 months among patients with intermediate- and poor-risk disease was significantly greater among those in nivolumab-ipilimumab group than the sunitinib group (66% vs 53%, respectively). The ORR was significantly higher in the nivolumab-ipilimumab treatment arm than the sunitinib treatment arm (42% vs 29%; P =.0001), with a CR rate of 11% vs 1%, respectively. Progression-free survival at 24 months was 30% in the nivolumab-ipilimumab group compared with 17% in the sunitinib group.

This follow-up study found no significant differences in outcomes between the 2 treatment groups among patients with favorable-risk disease.

The longer follow-up did not reveal any new safety concerns, according to the investigators.

Read more of Cancer Therapy Advisor‘s coverage of the 2019 Genitourinary Cancers Symposium by visiting the conference page.


  1. Tannir NM, Frontera OA, Hammers HJ, et al. 30-month follow-up of the phase 3 CheckMate 214 trial of first-line nivolumab + ipilimumab (N+I) or sunitinib (S) in patients (pts) with advanced renal cell carcinoma (aRCC). Data presented at: the 2019 Genitourinary Cancers Symposium; San Francisco, CA; February 14-16, 2019. Abstract 547.
  2. Motzer RJ, Tannir NM, McDermott DF, et al. Nivolumab plus ipilimumab versus sunitinib in advanced renal-cell carcinoma. N Engl J Med. 2018;378(14):1277-1290.