Author(s): Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K,
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Abstract PURPOSE: 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. CONCLUSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT00032045 NCT00058279 NCT00077532 NCT00094653 NCT00135408 NCT00261365 NCT00289627 NCT00289640 NCT00324155 NCT00623766. © 2015 by American Society of Clinical Oncology.
This article was published in J Clin Oncol
and referenced in Journal of Clinical & Experimental Cardiology