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).

Among the intention-to-treat population, nivolumab plus ipilimumab improved overall survival (not reached vs 37.9 months; HR, 0.71; 95% CI, 0.59-0.86; P =.0003), progression-free survival (median 9.7 months vs 9.7 months, P =.027), and the proportion of patients achieving objective response (41% vs 34%; P =.015).

Finally, a greater proportion of patients assigned to receive nivolumab plus ipilimumab achieved a durable response that lasted at least 18 months, and had ongoing response at data lock.

The adverse event profile was said to be manageable, with no new safety signals emerging.

“These results show the long-term benefits of nivolumab plus ipilimumab in patients with previously untreated advanced renal cell carcinoma. The long-term overall survival benefits, high proportions of complete response and ongoing response, and paucity of chronic toxicity with nivolumab plus ipilimumab after extended follow-up compares favorably with available reports of other combination regimens in first-line advanced renal cell carcinoma,” the researchers wrote. “Our results also support future analyses exploring the role for nivolumab plus ipilimumab in treating novel patient populations and ongoing studies combining nivolumab plus ipilimumab with novel drugs to further improve outcomes for patients with advanced renal cell carcinoma.”

Disclosure: This study was funded by Bristol-Myers Squibb and ONO Pharmaceutical. For a full list of disclosures, please refer to the original study.


Motzer RJ, Rini BI, McDermott DF, et al. Nivolumab plus ipilimumab versus sunitinib in first-line treatment for advanced renal cell carcinoma: extended follow-up of efficacy and safety results from a randomized, controlled phase 3 trial [published online August 16, 2019]. Lancet Oncol. doi: 10.1016/S1470-2045(19)30413-9