Long-Term Phase III Trial Results With Adjuvant Ipilimumab for Advanced Melanoma
Posted: Monday, October 28, 2019
According to a long-term follow-up report, adjuvant ipilimumab significantly improved recurrence-free, distant metastasis–free, and overall survival compared with placebo among patients with advanced melanoma who underwent complete resection. Alexander M.M. Eggermont, MD, PhD, of Gustave Roussy Cancer Institute, Villejuif, France, and colleagues observed a durable and sustained benefit that was consistent among patient subgroups. The results of this EORTC 18071 trial were published in the European Journal of Cancer.
The authors randomly assigned 951 patients with high-risk stage III cutaneous melanoma with complete resection to receive infusions of ipilimumab or placebo. These patients, who were from 91 hospitals in 19 countries, had not received previous systemic therapy for melanoma. Of those patients, 431 were still alive at the analysis performed in 2016, and recent follow-up information was available for 264 patients. The median follow-up for overall survival was 6.9 years.
The median recurrence-free survival in the ipilimumab group was 26.1 months versus 17.1 months in the placebo group (hazard ratio = 0.75; P < .001). Distant metastasis–free survival (hazard ratio = 0.76; P = .002), and overall survival (hazard ratio = 0.73; P = .002) were also significantly better among patients treated with ipilimumab than among those treated with placebo. There was an 8.7% absolute difference in overall survival between the two groups.
“The risk-benefit ratio of adjuvant ipilimumab at this dose and schedule requires additional assessment based on distant metastasis–free survival and overall survival endpoints to define its definitive value,” the authors concluded.
Disclosure: For full disclosures of study authors, visit ejcancer.com.