Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma

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. The primary analysis pooled OS data for 1,861 patients from 10 prospective and two retrospecti...

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Veröffentlicht in:Journal of clinical oncology Jg. 33; H. 17; S. 1889
Hauptverfasser: Schadendorf, Dirk, Hodi, F Stephen, Robert, Caroline, Weber, Jeffrey S, Margolin, Kim, Hamid, Omid, Patt, Debra, Chen, Tai-Tsang, Berman, David M, Wolchok, Jedd D
Format: Journal Article
Sprache:Englisch
Veröffentlicht: United States 10.06.2015
Schlagworte:
Antibodies, Monoclonal - administration & dosage
Antibodies, Monoclonal - adverse effects
Antibodies, Monoclonal - therapeutic use
Antineoplastic Agents - administration & dosage
Antineoplastic Agents - adverse effects
Antineoplastic Agents - therapeutic use
Clinical Trials, Phase II as Topic
Clinical Trials, Phase III as Topic
Drug Administration Schedule
Follow-Up Studies
Humans
Ipilimumab
Kaplan-Meier Estimate
Melanoma - drug therapy
Melanoma - secondary
Prospective Studies
Retrospective Studies
Skin Neoplasms - drug therapy
Skin Neoplasms - pathology
Treatment Outcome
ISSN:1527-7755, 1527-7755
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Zusammenfassung: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. 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. 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. 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.
Bibliographie:ObjectType-Article-1
SourceType-Scholarly Journals-1
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ISSN:1527-7755
1527-7755
DOI:10.1200/JCO.2014.56.2736