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Published in: International Journal of Clinical Oncology 2/2024

Open Access 29-12-2023 | Ibrutinib | Original Article

Phase 2 study of ibrutinib plus venetoclax in Japanese patients with relapsed/refractory mantle cell lymphoma

Authors: Hideki Goto, Satoshi Ito, Masahiro Kizaki, Masaki Yamaguchi, Noriko Fukuhara, Koji Kato, Toko Saito, Yasuhito Terui, Sumiko Okubo, Tomomi Soshin, Jiewei Zeng, Hideyuki Honda, Mohamed Badawi, Jeremy A. Ross, Koji Izutsu

Published in: International Journal of Clinical Oncology | Issue 2/2024

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Abstract

Background

Despite high response rates to initial therapy, most patients with mantle cell lymphoma (MCL) experience relapsed or refractory (R/R) disease. Here, we report the efficacy, safety, and pharmacokinetics of the Phase 2, single-arm M20-075 study (NCT04477486) of ibrutinib and venetoclax combination therapy in Japanese patients with R/R MCL.

Methods

Patients received 560 mg ibrutinib and 400 mg venetoclax (after a 5-week ramp-up from 20 mg) once daily for up to 104 weeks. Primary endpoint was complete response (CR) rate by independent review committee (IRC). Secondary endpoints included overall response rate (ORR), duration of response (DOR), undetectable minimal residual disease (uMRD) rate, progression-free survival (PFS), overall survival (OS), safety including dose-limiting toxicity (DLT) assessment in the first six patients, and pharmacokinetic parameters. Full analysis set (FAS) comprised all treated patients. Per protocol set (PPS) excluded treated patients with non-evaluable disease at baseline by IRC.

Results

Thirteen patients were treated (FAS n = 13; PPS, n = 12). Median age was 71 years, patients had a median of two prior treatments. After a median follow-up of 9.6 months, IRC-assessed CR rate and ORR were both 83% (PPS). All six MRD-evaluable patients had uMRD. Median DOR, PFS, and OS were unreached. The most common Grade ≥ 3 treatment-emergent adverse event (TEAE) was neutropenia (23%); 1 patient discontinued due to squamous cell carcinoma of the lung. No DLTs, tumor lysis syndrome, or deaths related to TEAEs were observed.

Conclusion

Ibrutinib plus venetoclax exhibited high response rates and a well-tolerated safety profile in Japanese patients with R/R MCL.
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Metadata
Title
Phase 2 study of ibrutinib plus venetoclax in Japanese patients with relapsed/refractory mantle cell lymphoma
Authors
Hideki Goto
Satoshi Ito
Masahiro Kizaki
Masaki Yamaguchi
Noriko Fukuhara
Koji Kato
Toko Saito
Yasuhito Terui
Sumiko Okubo
Tomomi Soshin
Jiewei Zeng
Hideyuki Honda
Mohamed Badawi
Jeremy A. Ross
Koji Izutsu
Publication date
29-12-2023
Publisher
Springer Nature Singapore
Published in
International Journal of Clinical Oncology / Issue 2/2024
Print ISSN: 1341-9625
Electronic ISSN: 1437-7772
DOI
https://doi.org/10.1007/s10147-023-02443-6

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