title: Four-year survival rates for patients with metastatic melanoma who received ipilimumab in phase II clinical trials.
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.
  
  
  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.
authors.affiliation: Ludwig Institute of Cancer Research, Ludwig Center for Cancer Immunotherapy, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA. wolchokj@mskcc.org
authors.forename: J D
authors.initials: JD
authors.lastname: Wolchok
authors.forename: J S
authors.initials: JS
authors.lastname: Weber
authors.forename: M
authors.initials: M
authors.lastname: Maio
authors.forename: B
authors.initials: B
authors.lastname: Neyns
authors.forename: K
authors.initials: K
authors.lastname: Harmankaya
authors.forename: K
authors.initials: K
authors.lastname: Chin
authors.forename: L
authors.initials: L
authors.lastname: Cykowski
authors.forename: V
authors.initials: V
authors.lastname: de Pril
authors.forename: R
authors.initials: R
authors.lastname: Humphrey
authors.forename: C
authors.initials: C
authors.lastname: Lebbé
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D060908:CTLA-4 Antigen / Q000037:antagonists & inhibitors; D005500:Follow-Up Studies; D006801:Humans; D007167:Immunotherapy / Q000379:methods; D000074324:Ipilimumab; D008545:Melanoma / Q000188:drug therapy* / Q000401:mortality* / Q000556:secondary; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D060908:CTLA-4 Antigen; D000074324:Ipilimumab
keywords: cytotoxic T-lymphocyte antigen-4; immunotherapy; ipilimumab; long-term survival; metastatic melanoma; survival rate