Combination Therapy Improves Outcomes in Advanced Renal Cell Carcinoma

A drug combination involving nivolumab showed significantly higher overall survival and objective response rates than sunitinib monotherapy in patients with renal-cell carcinoma, according to a study published in The New England Journal of Medicine (online: April 5, 2018 doi:10.1056/NEJMoa1712126).

Robert J Motzer, MD, Memorial Sloan Kettering Cancer Center, and colleagues compared nivolumab plus ipilimumab vs sunitinib for previously untreated clear-cell advanced renal-cell carcinoma.

The phase III trial randomized patients (1:1) to receive either nivolumab plus ipilimumab intravenously every 3 weeks for four doses, followed by nivolumab every 2 weeks, or sunitinib orally once daily for 4 weeks.

Authors of the study noted the co-primary end points were overall survival, objective response rate, and progression-free survival among patients with intermediate or poor prognostic risk.

A total of 1,096 patients were assigned to receive nivolumab plus ipilimumab (n=550) or sunitinib (n=546). A total of 425 and 422 patients, respectively, had intermediate or poor risk disease.

Researchers reported that after a median follow-up of 25.2 months in intermediate- and poor-risk patients, the 18-month overall survival rate was 75% with nivolumab plus ipilimumab and 60% with sunitinib; the median overall survival was not reached with nivolumab plus ipilimumab versus 26 months with sunitinib. The objective response rate was 42% vs 27%, and the complete response rate was 9% vs 1%, respectively. The median progression-free survival was 11.6 months and 8.4 months, respectively.

Additionally, Dr Motzer and colleagues reported treatment-related adverse events occurred in 93% of patients in the nivolumab-plus-ipilimumab group and 97% of patients in the sunitinib group; grade 3/4 events occurred in 46% and 63% of patients, respectively. Treatment-related adverse events leading to discontinuation occurred in 22% and 12% of the patients in the respective groups.

“Overall survival and objective response rates were significantly higher with nivolumab plus ipilimumab than with sunitinib among intermediate- and poor-risk patients with previously untreated advanced renal-cell carcinoma,” authors concluded.—Janelle Bradley

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