First-line nivolumab plus ipilimumab vs sunitinib in patients without nephrectomy and with an evaluable primary renal tumor in the CheckMate 214 trial

European UrologyAlbiges L, Tannir NM, Burotto M, et al. | November 09, 2021


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.

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