Real-world effectiveness and safety of ibrutinib in relapsed/refractory mantle cell lymphoma in Japan: post-marketing surveillance

Int J Hematol. 2024 Feb;119(2):146-155. doi: 10.1007/s12185-023-03687-8. Epub 2024 Jan 9.

Abstract

Efficacy and safety data for ibrutinib in Japanese patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) were limited at the time of its approval in Japan. All-case post-marketing surveillance was conducted in Japanese R/R MCL patients who began ibrutinib treatment between December 2016 and December 2017, and patients were followed until 30 June 2020. In the effectiveness analysis set (n = 202), the overall response rate was 59.9%, 52-week progression-free survival was 47.5%, and overall survival was 69.3%. Safety was assessed in 248 patients (median age 74.0 years). When ibrutinib treatment was started, patients had received a median of three prior lines of therapy. The overall incidence of adverse events (AE) was 74.6%, and AE frequency and severity grade distribution were similar between patients with 1 versus more than 1 prior line of therapy. The most common AE was platelet count decreased (all grades; 10.4%), similarly to previous observations in patients with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma. Five patients (2.0%) developed atrial fibrillation. The effectiveness and safety of ibrutinib were consistent with its known profile at approval in Japan. These results suggest that ibrutinib is effective and safe in Japanese R/R MCL patients in routine clinical practice.

Keywords: Ibrutinib; Mantle cell lymphoma; Post-market surveillance; Real-world evidence; Safety.

MeSH terms

  • Adenine* / analogs & derivatives
  • Adult
  • Aged
  • Humans
  • Japan / epidemiology
  • Leukemia, Lymphocytic, Chronic, B-Cell* / drug therapy
  • Lymphoma, Mantle-Cell* / drug therapy
  • Lymphoma, Mantle-Cell* / pathology
  • Piperidines* / therapeutic use
  • Product Surveillance, Postmarketing
  • Tyrosine Kinase Inhibitors* / therapeutic use

Substances

  • Adenine
  • ibrutinib
  • Piperidines
  • Tyrosine Kinase Inhibitors