Efficacy and safety of ipilimumab monotherapy in patients with pretreated advanced melanoma: A multicenter single-arm phase II study

S. J. O'Day, M. Maio, V. Chiarion-Sileni, T. F. Gajewski, H. Pehamberger, I. N. Bondarenko, P. Queirolo, L. Lundgren, S. Mikhailov, L. Roman, C. Verschraegen, R. Humphrey, R. Ibrahim, V. de Pril, A. Hoos, J. D. Wolchok

Research output: Contribution to journalArticlepeer-review

Abstract

Background: This phase II study evaluated the safety and activity of ipilimumab, a fully human mAb that blocks cytotoxic T-lymphocyte antigen-4, in patients with advanced melanoma. Patients and methods: Patients with previously treated, unresectable stage III/stage IV melanoma received 10 mg/kg ipilimumab every 3 weeks for four cycles (induction) followed by maintenance therapy every 3 months. The primary end point was best overall response rate (BORR) using modified World Health Organization (WHO) criteria. We also carried out an exploratory analysis of proposed immune-related response criteria (irRC). Results: BORR was 5.8% with a disease control rate (DCR) of 27% (N = 155). One-and 2-year survival rates (95% confidence interval) were 47.2% (39.5% to 55.1%) and 32.8% (25.4% to 40.5%), respectively, with a median overall survival of 10.2 months (7.6-16.3). Of 43 patients with disease progression by modified WHO criteria, 12 had disease control by irRC (8% of all treated patients), resulting in a total DCR of 35%. Adverse events (AEs) were largely immune related, occurring mainly in the skin and gastrointestinal tract, with 19% grade 3 and 3.2% grade 4. Immune-related AEs were manageable and generally reversible with corticosteroids. Conclusion: Ipilimumab demonstrated clinical activity with encouraging long-term survival in a previously treated advanced melanoma population.

Original languageEnglish
Pages (from-to)1712-1717
Number of pages6
JournalAnnals of Oncology
Volume21
Issue number8
DOIs
Publication statusPublished - Feb 10 2010

Keywords

  • Cytotoxic T-lymphocyte antigen-4
  • Immunotherapy
  • Ipilimumab
  • Metastatic melanoma
  • Phase II clinical trial

ASJC Scopus subject areas

  • Oncology
  • Hematology

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