Findings in Pooled Analysis of Long-Term Survival With Ipilimumab in Advanced Melanoma


Key Points

  • Three-year overall survival was 26% in treatment-naive patients and 20% in previously treated patients receiving ipilimumab for unresectable or metastatic melanoma.
  • A plateau in the survival curve at about 20% was observed beginning at around 3 years.

In a pooled analysis reported in the Journal of Clinical Oncology, Schadendorf et al found 3-year overall survival rates of 26% and 20% in treatment-naive and previously treated patients receiving ipilimumab (Yervoy)-based treatment for unresectable or metastatic melanoma. A survival curve plateau was observed at around 3 years, with follow-up out to 10 years.

Study Details

The study involved pooled data on 1,861 patients from 10 prospective studies, including two phase III trials, and two retrospective studies with populations of 36 to 540 patients. Of them, 1,257 patients had received prior treatment, and 604 were treatment-naive. Most patients received ipilimumab at 3 mg/kg (n = 965) or 10 mg/kg (n = 706).

Overall Survival

Median overall survival was 11.4 months (95% confidence interval [CI] = 10.7–12.1 months) among all patients, 13.5 months (95% CI = 11.9–15.4 months) in treatment-naive patients and 10.7 months (95% CI = 9.6–11.4 months) in previously treated patients, with 3-year survival rates of 22%, 26%, and 20%. Median overall survival was 11.4 months in patients receiving 3 mg/kg, 11.1 months in those receiving 10 mg/kg, and 12.4 months in those receiving other doses, with 3-year survival rates of 21%, 24%, and 20%. A total of 254 patients had ≥ 3 years of survival follow-up. The survival curve began to plateau at approximately 20% around year 3, with follow-up of up to 10 years.

In analysis of 4,848 patients including 2,985 patients from an expanded access program, median overall survival was 9.5 months (95% CI = 9.0–10.0 months), with a plateau at approximately 20% in the survival curve beginning around year 3.

The investigators concluded: “To our knowledge, this is the largest analysis of [overall survival] to date for ipilimumab-treated patients with advanced melanoma. We observed a plateau in the survival curve, beginning at approximately 3 years, which was independent of prior therapy or ipilimumab dose. These data add to the evidence supporting the durability of long-term survival in ipilimumab-treated patients with advanced melanoma.”

Dirk Schadendorf, MD, of University Hospital Essen, is the corresponding author of 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®.