Venetoclax treatment for chronic lymphocytic leukemia/small lymphocytic leukemia in Japan: post-marketing surveillance

Abstract

Venetoclax was approved for relapsed/refractory chronic lymphocytic leukemia (R/R CLL) and small lymphocytic leukemia (SLL) in Japan in September 2019; however, clinical data in Japanese patients are limited. This all-case post-marketing surveillance assessed efficacy and safety in Japanese patients with R/R CLL/SLL who started venetoclax treatment between November 2019 and August 2020. Overall, the safety and efficacy analysis sets included 129 and 114 patients, respectively. The overall response rate (ORR) was 57.0%; ORRs were higher in patients with versus without concomitant rituximab (65.4% vs. 54.7%), and in patients with 1 versus ≥ 2 prior lines of therapies (72.5% vs. 44.4%). Adverse events (AEs) were reported in 66.7% of patients (86/129); the most common AEs were neutrophil count decreased (22.5%), white blood cell count decreased (7.8%), and tumor lysis syndrome (TLS; 6.2%). AEs of special interest (TLS, myelosuppression, and infection) were manageable in clinical practice in Japan. Venetoclax is efficacious and safe for R/R CLL/SLL patients in the real-world setting in Japan. ClinicalTrials.gov ID: NCT04198415.

Keywords: Chronic lymphocytic leukemia; Japan; Post-marketing surveillance; Venetoclax.

Fig. 1

Study populations. CRF case report form

Fig. 2

Efficacy of venetoclax in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma. CR complete response; CRi complete response with incomplete bone marrow recovery; OR objective response; ORR overall response rate; PD progressive disease; PR partial response; SD stable disease. ^aTotal n = 112 in this group, which does not include 1 patient (with PD) who did not have information on prior lines of therapy recorded and 1 patient (with SD) who received venetoclax in the first line