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Efficacy and safety of tisagenlecleucel in Japanese adult patients with relapsed/refractory diffuse large B-cell lymphoma

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Title: Efficacy and safety of tisagenlecleucel in Japanese adult patients with relapsed/refractory diffuse large B-cell lymphoma
Authors: Goto, Hideki Browse this author →KAKEN DB
Makita, Shinichi Browse this author
Kato, Koji Browse this author
Tokushige, Kota Browse this author
Fujita, Taizo Browse this author
Akashi, Koichi Browse this author →KAKEN DB
Izutsu, Koji Browse this author →KAKEN DB
Teshima, Takanori Browse this author →KAKEN DB
Keywords: Tisagenlecleucel
CAR T-cell therapy
Diffuse large B-cell lymphoma
Issue Date: Sep-2020
Publisher: Springer
Journal Title: International journal of clinical oncology
Volume: 25
Start Page: 1736
End Page: 1743
Publisher DOI: 10.1007/s10147-020-01699-6
Abstract: Background Tisagenlecleucel demonstrated a high rate of durable response in adult patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL) in the pivotal global phase 2 JULIET study. Here, we report the efficacy and safety of tisagenlecleucel in the Japanese subgroup. Methods JULIET (NCT02445248) is a single-arm, open-label, multicenter, phase 2 study involving adult patients with r/r DLBCL who either relapsed after or were ineligible for autologous stem cell transplant. Primary endpoint was best overall response rate (ORR; complete response [CR] + partial response [PR]) as judged by an independent review committee. Results In Japan, of 17 patients enrolled, 9 were infused with tisagenlecleucel and completed >= 3 months of follow-up. Best ORR was 77.8% (7/9; 95% confidence interval, 40.0-97.2), with 5 patients (55.6%) in CR and 2 (22.2%) in PR. Cytokine release syndrome (CRS) occurred in 6 patients (66.7%), with grade 3 CRS in 2 patients (Penn grading scale). Two patients received tocilizumab. Two deaths (22.2%) occurred more than 30 days after tisagenlecleucel infusion due to disease progression, neither of which were related to tisagenlecleucel. Conclusion Tisagenlecleucel showed a high best ORR with a manageable safety profile, thus offering a new treatment option in selected Japanese patients with r/r DLBCL.
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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