Are Two Monoclonal Antibodies Better Than One in Advanced Melanoma?
Posted: Thursday, March 22, 2018
Just as nivolumab combined with ipilimumab resulted in significantly longer progression-free survival and a higher objective response rate in patients with advanced melanoma, versus ipilimumab alone, the combination significantly increased 3-year overall survival in those patients, according to updated results from the phase III CheckMate 067 trial published in The New England Journal of Medicine. The team, led by Jedd D. Wolchok, MD, PhD, of Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, noted that nivolumab alone, as well as the combination therapy, bested the overall survival rate with ipilimumab alone, but overall survival was highest with the combination.
Conducted at 137 sites in 21 countries, the study enrolled 1,296 patients from July 2013 to March 2014. Patients treated with the combination of the two monoclonal antibodies (n = 314) had not reached median overall survival after 36 months. For the nivolumab-alone (n = 316) and ipilimumab-alone (n = 315) groups, median overall survival was 37.6 and 19.9 months, respectively. The overall survival rates at 3 years for the combination group, nivolumab group, and ipilimumab group were 58%, 52%, and 34%, respectively.
Along with the increased survival did come increased grade 3/4 treatment-related adverse events: They occurred in 59% of the combination group, 21% of the nivolumab group, and 28% of the ipilimumab group. However, “most immune-mediated adverse events resolved within 3 to 4 weeks when well-established safety guidelines (involving the use of immune-modulating agents as appropriate) were followed,” the authors noted.