Nivolumab Versus Ipilimumab in Patients With Resected Advanced Melanoma
Posted: Thursday, March 22, 2018
Adjuvant therapy with nivolumab resulted in significantly longer recurrence-free survival and a lower rate of adverse events compared with ipilimumab for patients with resected stage III or IV melanoma. Jeffrey Weber, MD, PhD, of the Perlmutter Cancer Center at the NYU Langone Medical Center, and colleagues published these phase III study results in The New England Journal of Medicine.
Researchers selected 906 patients who were undergoing complete resection of stage IIIB, IIIC, or IV melanoma. They were then assigned to receive either nivolumab (453 patients) at a dose of 3 mg/kg of body weight every 2 weeks or ipilimumab (453 patients) at a dose of 10 mg/kg every 3 weeks for 4 doses and then every 12 weeks.
With at least 18 months of follow-up, the nivolumab group had a 12-month recurrence-free survival rate of 70.5% compared with 60.8% for the ipilimumab group (with a hazard ratio of 0.65). Nivolumab patients also had fewer treatment-related grade 3 or 4 adverse events (14.4%) than their ipilimumab counterparts (45.9%), and 9.7% of patients given nivolumab discontinued treatment. Treatment was discontinued in 42.6% of patients in the ipilimumab cohort.
Furthermore, Dr. Weber and colleagues focused attention on a subgroup analysis based on PD-L1 status. They found a benefit with nivolumab versus ipilimumab in all subgroups, including those categorized by age, sex, disease stage, microscopic versus macroscopic nodal disease, ulceration status of the primary tumor, and BRAF status.