Long-term outcomes of venetoclax and ibrutinib in Japanese patients with relapsed/refractory mantle cell lymphoma.

ABSTRACT:

Background

Patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) face a poor prognosis in the absence of effective treatment options. Ibrutinib plus venetoclax demonstrated high response rates and a tolerable safety profile in the primary analysis of the Phase 2, M20-075 study (NCT04477486) in Japanese patients with R/R MCL. We report updated efficacy and safety from this study with longer follow-up.

Methods

Patients received 560 mg ibrutinib and 400 mg venetoclax (5-week ramp-up to 400 mg) once daily for up to 104 weeks followed by ibrutinib monotherapy. Primary endpoint was Independent Review Committee-assessed complete response (CR) rate. Secondary endpoints included overall response rate (ORR), duration of response (DOR), undetectable minimal residual diseas

SUBMITTER: Goto H 

PROVIDER: S-EPMC12568793 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature