Five-Year Analysis Indicates Potential for Long‑Term Survival With Ipilimumab Plus Dacarbazine in Advanced Melanoma


Key Points

  • Five-year overall survival was 18% with ipilimumab-dacarbazine in treatment-naive patients with advanced melanoma.
  • In long-term survivors receiving maintenance ipilimumab, grade 3 or 4 immune-related adverse events involved only the skin.

In an analysis reported in the Journal of Clinical Oncology, Maio et al found a 5-year survival rate of 18% among treatment-naive patients receiving ipilimumab (Yervoy) plus dacarbazine in a phase III trial. The findings support other data indicating long-term survival in some patients receiving ipilimumab in this setting.

Study Details

In the phase III CA184-024 trial, patients with unresectable stage III or IV disease were randomly assigned to ipilimumab at 10 mg/kg plus dacarbazine (n = 250) or placebo plus dacarbazine (n = 252) at weeks 1, 4, 7, and 10 followed by dacarbazine alone every 3 weeks through week 22. Eligible patients could receive maintenance ipilimumab or placebo every 12 weeks beginning at week 24. In the initial overall survival analysis, median survival was 11.2 vs 9.1 months (hazard ratio [HR] = 0.72, P < .001).

Long-Term Survival

In the updated analysis, median overall survival was 11.2 vs 9.1 months (HR = 0.69, 95% confidence interval [CI] = 0.57–0.84). At a minimum follow-up of 5 years, overall survival was 18.2% (95% CI = 13.6%–23.4%) in the ipilimumab group vs 8.8% (95% CI = 5.7%–12.8%) in the placebo group (P = .002). Overall survival at 1, 2, 3, and 4 years was 48% vs 36%, 29% vs 18%, 21% vs 12%, and 19.1% vs 9.7%. Among the 40 patients in the ipilimumab group and 20 in the placebo group surviving ≥ 5 years, 30% and 55% received at least one subsequent treatment.

Among the seven patients who received maintenance ipilimumab and survived ≥ 5 years, grade 3 or 4 immune-related adverse events were observed only in the skin, with the two observed events (rash and pruritus) occurring in the same patient.

The investigators concluded: “The additional survival benefit of ipilimumab plus dacarbazine is maintained with twice as many patients alive at 5 years compared with those who initially received placebo plus dacarbazine. These results demonstrate a durable survival benefit with ipilimumab in advanced melanoma.”

Michele Maio, MD, PhD, of University Hospital of Siena, is the corresponding author for the Journal of Clinical Oncology article.

The study was supported by Bristol-Myers Squibb. For full disclosures of the study authors, visit

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.