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Ann Oncol. 2013 Aug;24(8):2174-80. doi: 10.1093/annonc/mdt161. Epub 2013 May 10.

Four-year survival rates for patients with metastatic melanoma who received ipilimumab in phase II clinical trials.

Author information

1
Ludwig Institute of Cancer Research, Ludwig Center for Cancer Immunotherapy, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA. wolchokj@mskcc.org

Abstract

BACKGROUND:

This analysis was carried out to evaluate the long-term survival of patients with metastatic melanoma who received ipilimumab, a fully human monoclonal antibody that binds to cytotoxic T-lymphocyte antigen-4, in clinical trials.

PATIENTS AND METHODS:

Patients received ipilimumab in one of three completed phase II clinical trials (CA184-008, CA184-022, and CA184-007). Previously treated patients were enrolled in all studies, and treatment-naïve patients were also included in study CA184-007. Patients received ipilimumab at a dose of 10 mg/kg in studies CA184-008 and CA184-007, and at doses of 0.3, 3, or 10 mg/kg in study CA184-022. Ipilimumab was given every 3 weeks for four doses, and eligible patients could receive ipilimumab maintenance therapy every 12 weeks. In study CA184-022, patients could cross over to be retreated with ipilimumab at 10 mg/kg upon disease progression. Ongoing survival follow-up is conducted in a companion study, CA184-025.

RESULTS:

Four-year survival rates [95% confidence interval (95% CI)] for previously treated patients who received ipilimumab at 0.3, 3, or 10 mg/kg were 13.8% [6.1-22.5], 18.2% [9.5-27.6], and 19.7% [13.4-26.5] to 28.4% [13.9-44.2], respectively. In treatment-naïve patients who received ipilimumab at 10 mg/kg, 4-year survival rates were 37.7% [18.6-57.4] to 49.5% [23.8-75.4].

CONCLUSIONS:

These results demonstrate durable survival in a significant proportion of patients with metastatic melanoma who received ipilimumab therapy.

KEYWORDS:

cytotoxic T-lymphocyte antigen-4; immunotherapy; ipilimumab; long-term survival; metastatic melanoma; survival rate

PMID:
23666915
PMCID:
PMC4081656
DOI:
10.1093/annonc/mdt161
[Indexed for MEDLINE]
Free PMC Article

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