Albiges L, Tannir NM, Burotto M, et al. - Compared with sunitinib, nivolumab plus ipilimumab (NIVO+IPI) conferred survival benefits as well as renal tumor reduction in patients with advanced renal cell carcinoma (aRCC) without prior nephrectomy and with an evaluable primary tumor.

• This is an exploratory post hoc analysis evaluating first-line NIVO+IPI vs sunitinib in a subgroup of 108 patients with aRCC without prior nephrectomy and with an evaluable primary tumor.

• Clear cell aRCC patients were randomly assigned to NIVO+IPI every 3 wk for four doses followed by NIVO monotherapy, or sunitinib every day for 4 wk (6-wk cycle).

• Overall survival, observed during 4 yrs, favored NIVO+IPI over sunitinib (hazard ratio 0.63) in patients without prior nephrectomy.

• Higher objective response rate (34% vs 15%) and longer median duration of response (20.5 vs 14.1 mo) were achieved with NIVO+IPI vs sunitinib; the best overall response was partial response in either arm.

• A ≥30% decrease in the diameter of intact target renal tumors was obtained in 35% of patients with NIVO+IPI vs 20% with sunitinib.

• Safety profile was consistent with the global study population.