Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma

Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma

May 31, 2015 | Larkin, J., Chiarion-Sileni, V., Gonzalez, R., Grob, J., Cowey, C., Lao, C., Schadendorf, D., Dummer, R., Smylie, M., et. al.
This study, published in the New England Journal of Medicine, evaluated the efficacy and safety of nivolumab alone or in combination with ipilimumab compared to ipilimumab alone in previously untreated patients with metastatic melanoma. The randomized, double-blind, phase 3 trial included 945 patients. The primary endpoint was progression-free survival, with secondary endpoints including overall survival, objective response rate, and safety. The results showed that the combination of nivolumab and ipilimumab significantly improved progression-free survival compared to ipilimumab alone (hazard ratio, 0.42; P<0.001). The combination therapy also demonstrated higher objective response rates and was associated with manageable adverse events, particularly diarrhea, fatigue, and pruritus. The study concluded that the combination of nivolumab and ipilimumab provided longer progression-free survival and higher objective response rates than ipilimumab alone, with a safety profile consistent with previous experiences with these agents.This study, published in the New England Journal of Medicine, evaluated the efficacy and safety of nivolumab alone or in combination with ipilimumab compared to ipilimumab alone in previously untreated patients with metastatic melanoma. The randomized, double-blind, phase 3 trial included 945 patients. The primary endpoint was progression-free survival, with secondary endpoints including overall survival, objective response rate, and safety. The results showed that the combination of nivolumab and ipilimumab significantly improved progression-free survival compared to ipilimumab alone (hazard ratio, 0.42; P<0.001). The combination therapy also demonstrated higher objective response rates and was associated with manageable adverse events, particularly diarrhea, fatigue, and pruritus. The study concluded that the combination of nivolumab and ipilimumab provided longer progression-free survival and higher objective response rates than ipilimumab alone, with a safety profile consistent with previous experiences with these agents.
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