HealthDay News — For patients with previously untreated clear-cell advanced renal-cell carcinoma, nivolumab plus ipilimumab is associated with better overall survival than sunitinib, according to a study published online March 21 in the New England Journal of Medicine.
Robert J. Motzer, MD, from the Memorial Sloan Kettering Cancer Center in New York City, and colleagues randomized adults with previously untreated clear-cell advanced renal-cell carcinoma in a 1:1 ratio to receive nivolumab plus ipilimumab intravenously every 3 weeks for 4 doses followed by nivolumab every 2 weeks (550 patients) or to sunitinib orally once daily for 4 weeks (546 patients). Of the patients, 425 and 422, respectively, had intermediate or poor prognostic risk.
The researchers found that at a median follow-up of 25.2 months in intermediate- and poor-risk patients, the 18-month overall survival rate was 75 and 60% with nivolumab plus ipilimumab and sunitinib, respectively; the median overall survival was not reached with nivolumab plus ipilimumab and was 26.0 months with sunitinib (hazard ratio for death, 0.63). The objective and complete response rates were 42 versus 27% and 9 versus 1%, respectively. Median progression-free survival was 11.6 and 8.4 months with nivolumab plus ipilimumab and sunitinib, respectively (hazard ratio, 0.82).
“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,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Bristol-Myers Squibb and Ono Pharmaceutical, which funded the study.