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Zandelisib (ME-401) in Japanese patients with relapsed or refractory indolent non-Hodgkin's lymphoma : an open-label, multicenter, dose-escalation phase 1 study

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Title: Zandelisib (ME-401) in Japanese patients with relapsed or refractory indolent non-Hodgkin's lymphoma : an open-label, multicenter, dose-escalation phase 1 study
Authors: Goto, Hideki Browse this author →KAKEN DB
Izutsu, Koji Browse this author →KAKEN DB
Ennishi, Daisuke Browse this author
Mishima, Yuko Browse this author
Makita, Shinichi Browse this author
Kato, Koji Browse this author
Hanaya, Miyoko Browse this author
Hirano, Satoshi Browse this author
Narushima, Kazuya Browse this author
Teshima, Takanori Browse this author →KAKEN DB
Nagai, Hirokazu Browse this author
Ishizawa, Kenichi Browse this author
Keywords: Dose escalation
Follicular lymphoma
Marginal zone lymphoma
PI3K delta inhibitor
Issue Date: 1-Dec-2022
Publisher: Springer
Journal Title: International journal of hematology
Volume: 116
Issue: 6
Start Page: 911
End Page: 921
Publisher DOI: 10.1007/s12185-022-03450-5
Abstract: The selective phosphatidylinositol 3-kinase delta inhibitor zandelisib demonstrated favorable safety and efficacy [objective response rate (ORR) 79%] in patients with B-cell malignancies in a phase 1b study in the US and Switzerland. In this phase 1 dose-escalation study (NCT03985189), 9 Japanese patients with relapsed/refractory indolent non-Hodgkin's lymphoma (R/R iNHL) received zandelisib on a continuous daily schedule (45 or 60 mg) until progressive disease/unacceptable toxicity. No dose-limiting toxicities were observed. The maximum tolerated dose was not reached. At a median follow-up of 17.5 months, Grade >= 3 treatment-emergent adverse events that occurred in 2 or more patients were neutrophil count decreased (55.6%; 5/9) and diarrhea (33.3%; 3/9) Immune-related toxicities, including hepatobiliary disorder, aspartate/alanine aminotransferase increased, diarrhea/colitis, organizing pneumonia, stomatitis, and rash, led to zandelisib discontinuation in 4 patients. The investigator-assessed ORR, based on modified Lugano criteria, was 100%, including 2 complete responses (22.2%; in follicular lymphoma patients receiving 60 mg/day). Median duration of response, progression-free survival, and time to response were 7.9, 11.1, and 1.9 months, respectively. Zandelisib demonstrated a manageable safety profile at 60 mg, the recommended phase 2 dose (RP2D) in Japanese patients. The RP2D resulted in favorable pharmacokinetics and anti-tumor efficacy in Japanese patients with R/R iNHL.
Type: article
Appears in Collections:医学院・医学研究院 (Graduate School of Medicine / Faculty of Medicine) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

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