CheckMate 214: Long-Term Results Confirm Superiority of Nivolumab Plus Ipilimumab for mRCC

Promising Therapy for Patients with Advanced Kidney Cancer
Promising Therapy for Patients with Advanced Kidney Cancer
Superiority of the regimen was shown in intermediate- and poor-risk groups, as well as in intention-to-treat populations.

The superior efficacy of nivolumab plus ipilimumab compared with sunitinib in the treatment of intermediate- or poor-risk patients with previously untreated advanced renal cell carcinoma (RCC) was maintained with extended follow-up, according to results of the CheckMate 214 trial.

The ongoing, phase 3 CheckMate 214 trial randomly assigned 1096 patients with RCC to receive nivolumab plus ipilimumab or sunitinib. At a prespecified interim analysis of 17.5 months, nivolumab plus ipilimumab showed longer overall survival, with a higher proportion of patients achieving objective response compared with sunitinib.

However, the researchers added, “long-term updates crucially inform the value of immunotherapy-based regimens.”

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Now, at a median follow-up of 32.4 months — for patients with intermediate- or poor-risk disease — nivolumab plus ipilimumab continued to provide superior progression-free survival (median 8.2 months vs 8.3 months; P =.0014) with a greater proportion of patients achieving an objective response rate (42% vs 29%; P =.0001) compared with sunitinib.

“The progression-free survival curves for the two treatment groups only began to separate after around 9 months, and the 30-month progression-free survival probability was 28% (95% confidence interval [CI], 23–33) in the nivolumab plus ipilimumab group versus 12% (95% CI, 8–16) in the sunitinib group,” the researchers wrote.

In addition, the combination significantly improved overall survival compared with sunitinib (not reached vs 26.6 months; hazard ratio [HR], 0.66; 95% CI, 0.54-0.80; P <.0001).

This article originally appeared on Cancer Therapy Advisor