Phase II study of ipilimumab monotherapy in Japanese patients with advanced melanoma

N. Yamazaki, Y. Kiyohara, H. Uhara, S. Fukushima, H. Uchi, N. Shibagaki, A. Tsutsumida, S. Yoshikawa, R. Okuyama, Y. Ito, T. Tokudome

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Abstract

Purpose: Ipilimumab is designed to block cytotoxic T-lymphocyte antigen-4 to augment antitumor T cell responses. In studies of predominantly Caucasian patients with advanced melanoma, ipilimumab was associated with durable response, long-term survival benefit, and a manageable safety profile. This phase II study assessed the safety of ipilimumab in Japanese patients with unresectable stage III or IV melanoma. Methods: Patients received ipilimumab 3 mg/kg every 3 weeks for four doses. The database lock for the original analysis was in August 2014. Overall survival, progression-free survival, and data on deaths were based on an updated, follow-up analysis (database lock April 2015). Results: Data are reported from 20 patients. Fifteen patients (75 %) received all four doses of ipilimumab during induction. Twelve patients (60 %) had at least one drug-related adverse event (AE), and no patients discontinued due to a drug-related AE. There were no deaths related to study drug. The most common drug-related AEs were rash (n = 7), pyrexia (n = 3), increased aspartate aminotransferase (AST; n = 3), and increased alanine aminotransferase (ALT; n = 3). Twelve patients (60 %) reported immune-related AEs (irAEs); most frequent were skin (n = 9) and liver (n = 3) disorders. Grade 3 irAEs were ALT and AST elevation (n = 2) and diabetes mellitus (n = 1). Two patients had a partial response and two had stable disease, yielding a 20 % disease control rate. Median overall survival and progression-free survival were 8.71 and 2.74 months, respectively. Conclusion: Ipilimumab 3 mg/kg had a manageable AE profile in this Japanese patient population with clinical outcomes similar to that in Caucasian patients. ClinicalTrials.gov identifier: NCT01990859.

Original languageEnglish
Pages (from-to)997-1004
Number of pages8
JournalCancer chemotherapy and pharmacology
Volume76
Issue number5
DOIs
Publication statusPublished - Nov 1 2015

All Science Journal Classification (ASJC) codes

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)

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    Yamazaki, N., Kiyohara, Y., Uhara, H., Fukushima, S., Uchi, H., Shibagaki, N., Tsutsumida, A., Yoshikawa, S., Okuyama, R., Ito, Y., & Tokudome, T. (2015). Phase II study of ipilimumab monotherapy in Japanese patients with advanced melanoma. Cancer chemotherapy and pharmacology, 76(5), 997-1004. https://doi.org/10.1007/s00280-015-2873-x