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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 | JULIET |
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. |
Rights: | http://creativecommons.org/licenses/by/4.0/ |
Type: | article |
URI: | http://hdl.handle.net/2115/79103 |
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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