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).
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.
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.
- 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.
- 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.