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

• Published in: International journal of hematology Vol. 119; no. 2; pp. 146 - 155
• Main Authors: Maruyama, Dai, Omi, Ai, Nomura, Fumi, Touma, Tokiko, Noguchi, Yukiko, Takebe, Kyoko, Izutsu, Koji
• Format: Journal Article
• Language: English
• Published: Singapore Springer Nature Singapore 01.02.2024; Springer Nature B.V
• Subjects: Adenine - analogs & derivatives; Adult; Aged; Chronic lymphocytic leukemia; Effectiveness; Hematology; Humans; Japan - epidemiology; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell - drug therapy; Lymphatic leukemia; Lymphoma; Lymphoma, Mantle-Cell - drug therapy; Lymphoma, Mantle-Cell - pathology; Mantle cell lymphoma; Marketing; Medicine; Medicine & Public Health; Oncology; Original; Original Article; Patients; Piperidines - therapeutic use; Product Surveillance, Postmarketing; Safety; Surveillance; Survival; Tyrosine Kinase Inhibitors - therapeutic use; Japan; Safety; Post-market surveillance; Ibrutinib; Mantle cell lymphoma; Real-world evidence
• ISSN: 0925-5710; 1865-3774
• DOI: 10.1007/s12185-023-03687-8

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.