Adjuvant treatment with ipilimumab significantly improved overall survival, in contrast with placebo, among patients with high-risk, stage III melanoma.
The U.S. Food and Drug Administration approved ipilimumab for stage III melanoma in 2015 based on a study that demonstrated ipilimumab significantly improves recurrence-free survival. At the European Society for Medical Oncology (ESMO) 2016 Congress, researchers reported the impact of ipilimumab on overall survival and distant metastasis-free survival in this patient population.1
For the phase 3 study (ClinicalTrials.gov Identifier: NCT00636168), researchers enrolled 951 patients who underwent complete resection of stage III cutaneous melanoma. Of those, 20%, 44%, and 36% had stage IIIA, IIIB, and IIIC disease, respectively.
All participants were randomly assigned 1:1 to receive ipilimumab or placebo every 3 weeks for 4 doses, then every 3 months for up to 3 years until completion, disease recurrence, or unacceptable toxicity.
At a median follow-up of 5.3 years, results showed that ipilimumab significantly reduced the risk of death by 28% compared with placebo (hazard ratio [HR], 0.72; 95% CI, 0.58-0.88; P = .001).
Investigators also found that treatment with ipilimumab significantly reduced both recurrence-free survival (HR, 0.76; 95% CI, 0.64-0.89; P = .0008) and distant metastasis-free survival (HR, 0.76; 95% CI, 0.64-0.92; P = .002) by 24% versus placebo.
The rates of grade 3 to 4 adverse events were 54.1% with ipilimumab and 26.2% with placebo, which were consistent with previous reports.
The most common grade 3 to 4 immune-related adverse events among patients treated with ipilimumab were gastrointestinal, hepatic, and endocrine. A total of 53.3% of patients who received ipilimumab discontinued treatment due to adverse events and 1.1% died due to treatment-related toxicities.
These findings highlight the utility of adjuvant ipilimumab therapy as a treatment option for patients with high-risk, stage III melanoma.
- Eggermont AM, Chiarion-Sileni V, Grob J, et al. Ipilimumab (IPI) vs placebo (PBO) after complete resection of stage III melanoma: final overall survival results from the EORTC 18071 randomized, double-blind, phase 3 trial. Paper presented at: European Society for Medical Oncology (ESMO) 2016 Congress; October 7-11, 2016; Copenhagen, Denmark.