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

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

Dai Maruyama  1 , Ai Omi  2 , Fumi Nomura  3 , Tokiko Touma  4 , Yukiko Noguchi  3 , Kyoko Takebe  3 , Koji Izutsu  5
Affiliations

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

Dai Maruyama et al. Int J Hematol. 2024 Feb.

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.

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Conflict of interest statement

D. Maruyama has received research funding from Celgene, Novartis, Chugai, Ono Pharmaceutical, Takeda, Janssen, MSD, Bristol Myers Squibb, Sanofi, GSK, HUYA, Loxo Oncology, MEI Pharma, AstraZeneca, AbbVie, Symbio, Bayer, Mundipharma, Yakult, Kyowa Kirin, Otsuka, Amgen, Astellas Pharma, Eisai, and Taiho; and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Janssen, Mundipharma, Eisai, Chugai, Sanofi, Takeda, Celgene, Bristol Myers Squibb, Ono Pharmaceutical, AbbVie, Novartis, MSD, Kyowa Kirin, Zenyaku, AstraZeneca, Symbio, Meiji Seika Pharma, Nippon Shinyaku, and Eli Lilly. K. Izutsu has received consulting fees from Kyowa Kirin, Eisai, Genmab, AbbVie, Ono Pharmaceutical, and Daiichi Sankyo; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Eisai, Chugai, Janssen, AstraZeneca, Novartis, Bristol Myers Squibb, Celgene, Kyowa Kirin, AbbVie, Ono Pharmaceutical, Eli Lilly, MSD, Daiichi Sankyo, Kyorin Pharmaceutical, Symbio, Takeda, Allergan Japan, and FIJIFILM Toyama Chemical; and has received payment for participating on an advisory board for Takeda, Celgene, Genmab, AstraZeneca, AbbVie, and Janssen. A. Omi, F. Nomura, T. Touma, Y. Noguchi, and K. Takebe are full time employees of Janssen Pharmaceutical K.K.

Figures

Fig. 1
Fig. 1
Post-marketing surveillance populations
Fig. 2
Fig. 2
a Progression-free survival and b overall survival during ibrutinib treatment. Data are for the effectiveness analysis set. No. number, NR not reached, OS overall survival, PFS progression-free survival
Fig. 3
Fig. 3
Adverse events (other than mantle cell lymphoma progression and death) occurring in ≥ 3% of patients. WBC white blood cell
Fig. 4
Fig. 4
Adverse events (other than mantle cell lymphoma progression and death) by grade, overall and in patient subgroups. PLOT previous lines of therapy
Fig. 5
Fig. 5
Timing of onset for adverse events of special interest of a–e all grades and f–j Grade ≥ 3 in the safety analysis set (N = 248)
See this image and copyright information in PMC

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