Efficacy and safety of ibrutinib in Japanese patients with relapsed or refractory mantle cell lymphoma

Abstract

In this multicenter, single-arm, phase II study, efficacy and safety of ibrutinib were examined in Japanese patients with relapsed or refractory mantle cell lymphoma (MCL). Patients (age ≥ 20 years) with relapsed or refractory MCL who had progressed after receiving at least one prior treatment regimen, were enrolled. Patients were treated with oral ibrutinib (560 mg/once daily; 28-day cycle) until disease progression (or relapse), unacceptable toxicity, or study end. Primary endpoint was overall response rate (ORR). Secondary endpoints included duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and safety. Of the 16 patients who received treatment, 5 patients discontinued the study (progressive disease 4; sepsis 1). Median duration of ibrutinib exposure was 6.5 months (range, 2.8-8.3 months). The ORR was 87.5% (90% CI: 65.6-97.7; complete response =2 [12.5%]; partial response=12 [75.0%]). Median TTR for all responders (n=14) was 1.8 months (range, 0.7-5.3 months). The median DOR and PFS were not estimable due to censoring (range, DOR: 1.1 to 6.4+ months, PFS: 2.8 to 8.0+ months). OS data was immature due to the limited observation period. A total of 8/16 patients (50%) had at least one grade 3 adverse event (AE), and 5 (31.3%) patients reported serious AEs. The most commonly reported AEs were diarrhea and stomatitis (37.5% each), platelet count decreased (31.3%), and anemia (25%). Overall, orally administered single agent ibrutinib was efficacious with an acceptable safety profile in Japanese patients with relapsed or refractory MCL.

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