title: Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma.
abstract: OBJECTIVE
  To provide a more precise estimate of long-term survival observed for ipilimumab-treated patients with advanced melanoma, we performed a pooled analysis of overall survival (OS) data from multiple studies.
  
  
  METHODS
  The primary analysis pooled OS data for 1,861 patients from 10 prospective and two retrospective studies of ipilimumab, including two phase III trials. Patients were previously treated (n = 1,257) or treatment naive (n = 604), and the majority of patients received ipilimumab 3 mg/kg (n = 965) or 10 mg/kg (n = 706). We also conducted a secondary analysis of OS data (n = 4,846) with an additional 2,985 patients from an expanded access program. OS rates were estimated using the Kaplan-Meier method.
  
  
  RESULTS
  Among 1,861 patients, median OS was 11.4 months (95% CI, 10.7 to 12.1 months), which included 254 patients with at least 3 years of survival follow-up. The survival curve began to plateau around year 3, with follow-up of up to 10 years. Three-year survival rates were 22%, 26%, and 20% for all patients, treatment-naive patients, and previously treated patients, respectively. Including data from the expanded access program, median OS was 9.5 months (95% CI, 9.0 to 10.0 months), with a plateau at 21% in the survival curve beginning around year 3.
  
  
  CONCLUSIONS
  To our knowledge, this is the largest analysis of OS 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.
authors: Dirk Schadendorf, University Hospital Essen, Essen, Germany; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Caroline Robert, Institute Gustave Roussy, Villejuif, France; Jeffrey S. Weber, Moffitt Cancer Center, Tampa, FL; Kim Margolin, University of Washington, Seattle, WA; Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Debra Patt, The US Oncology Network, McKesson Specialty Health, Houston, TX; Tai-Tsang Chen, Bristol-Myers Squibb, Wallingford, CT; David M. Berman, Bristol-Myers Squibb, Lawrenceville, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY. Dirk.Schadendorf@uk-essen.de.
authors: Dirk
authors: D
authors: Schadendorf
authors: Dirk Schadendorf, University Hospital Essen, Essen, Germany; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Caroline Robert, Institute Gustave Roussy, Villejuif, France; Jeffrey S. Weber, Moffitt Cancer Center, Tampa, FL; Kim Margolin, University of Washington, Seattle, WA; Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Debra Patt, The US Oncology Network, McKesson Specialty Health, Houston, TX; Tai-Tsang Chen, Bristol-Myers Squibb, Wallingford, CT; David M. Berman, Bristol-Myers Squibb, Lawrenceville, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.
authors: F Stephen
authors: FS
authors: Hodi
authors: Dirk Schadendorf, University Hospital Essen, Essen, Germany; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Caroline Robert, Institute Gustave Roussy, Villejuif, France; Jeffrey S. Weber, Moffitt Cancer Center, Tampa, FL; Kim Margolin, University of Washington, Seattle, WA; Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Debra Patt, The US Oncology Network, McKesson Specialty Health, Houston, TX; Tai-Tsang Chen, Bristol-Myers Squibb, Wallingford, CT; David M. Berman, Bristol-Myers Squibb, Lawrenceville, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.
authors: Caroline
authors: C
authors: Robert
authors: Dirk Schadendorf, University Hospital Essen, Essen, Germany; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Caroline Robert, Institute Gustave Roussy, Villejuif, France; Jeffrey S. Weber, Moffitt Cancer Center, Tampa, FL; Kim Margolin, University of Washington, Seattle, WA; Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Debra Patt, The US Oncology Network, McKesson Specialty Health, Houston, TX; Tai-Tsang Chen, Bristol-Myers Squibb, Wallingford, CT; David M. Berman, Bristol-Myers Squibb, Lawrenceville, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.
authors: Jeffrey S
authors: JS
authors: Weber
authors: Dirk Schadendorf, University Hospital Essen, Essen, Germany; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Caroline Robert, Institute Gustave Roussy, Villejuif, France; Jeffrey S. Weber, Moffitt Cancer Center, Tampa, FL; Kim Margolin, University of Washington, Seattle, WA; Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Debra Patt, The US Oncology Network, McKesson Specialty Health, Houston, TX; Tai-Tsang Chen, Bristol-Myers Squibb, Wallingford, CT; David M. Berman, Bristol-Myers Squibb, Lawrenceville, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.
authors: Kim
authors: K
authors: Margolin
authors: Dirk Schadendorf, University Hospital Essen, Essen, Germany; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Caroline Robert, Institute Gustave Roussy, Villejuif, France; Jeffrey S. Weber, Moffitt Cancer Center, Tampa, FL; Kim Margolin, University of Washington, Seattle, WA; Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Debra Patt, The US Oncology Network, McKesson Specialty Health, Houston, TX; Tai-Tsang Chen, Bristol-Myers Squibb, Wallingford, CT; David M. Berman, Bristol-Myers Squibb, Lawrenceville, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.
authors: Omid
authors: O
authors: Hamid
authors: Dirk Schadendorf, University Hospital Essen, Essen, Germany; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Caroline Robert, Institute Gustave Roussy, Villejuif, France; Jeffrey S. Weber, Moffitt Cancer Center, Tampa, FL; Kim Margolin, University of Washington, Seattle, WA; Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Debra Patt, The US Oncology Network, McKesson Specialty Health, Houston, TX; Tai-Tsang Chen, Bristol-Myers Squibb, Wallingford, CT; David M. Berman, Bristol-Myers Squibb, Lawrenceville, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.
authors: Debra
authors: D
authors: Patt
authors: Dirk Schadendorf, University Hospital Essen, Essen, Germany; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Caroline Robert, Institute Gustave Roussy, Villejuif, France; Jeffrey S. Weber, Moffitt Cancer Center, Tampa, FL; Kim Margolin, University of Washington, Seattle, WA; Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Debra Patt, The US Oncology Network, McKesson Specialty Health, Houston, TX; Tai-Tsang Chen, Bristol-Myers Squibb, Wallingford, CT; David M. Berman, Bristol-Myers Squibb, Lawrenceville, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.
authors: Tai-Tsang
authors: TT
authors: Chen
authors: Dirk Schadendorf, University Hospital Essen, Essen, Germany; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Caroline Robert, Institute Gustave Roussy, Villejuif, France; Jeffrey S. Weber, Moffitt Cancer Center, Tampa, FL; Kim Margolin, University of Washington, Seattle, WA; Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Debra Patt, The US Oncology Network, McKesson Specialty Health, Houston, TX; Tai-Tsang Chen, Bristol-Myers Squibb, Wallingford, CT; David M. Berman, Bristol-Myers Squibb, Lawrenceville, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.
authors: David M
authors: DM
authors: Berman
authors: Dirk Schadendorf, University Hospital Essen, Essen, Germany; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Caroline Robert, Institute Gustave Roussy, Villejuif, France; Jeffrey S. Weber, Moffitt Cancer Center, Tampa, FL; Kim Margolin, University of Washington, Seattle, WA; Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Debra Patt, The US Oncology Network, McKesson Specialty Health, Houston, TX; Tai-Tsang Chen, Bristol-Myers Squibb, Wallingford, CT; David M. Berman, Bristol-Myers Squibb, Lawrenceville, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.
authors: Jedd D
authors: JD
authors: Wolchok
mesh_terms: D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D004334:Drug Administration Schedule; D005500:Follow-Up Studies; D006801:Humans; D000074324:Ipilimumab; D053208:Kaplan-Meier Estimate; D008545:Melanoma / Q000188:drug therapy* / Q000556:secondary; D011446:Prospective Studies; D012189:Retrospective Studies; D012878:Skin Neoplasms / Q000188:drug therapy / Q000473:pathology*; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D000970:Antineoplastic Agents; D000074324:Ipilimumab