TY - JOUR
T1 - Efficacy and safety of tisagenlecleucel in Japanese adult patients with relapsed/refractory diffuse large B-cell lymphoma
AU - Goto, Hideki
AU - Makita, Shinichi
AU - Kato, Koji
AU - Tokushige, Kota
AU - Fujita, Taizo
AU - Akashi, Koichi
AU - Izutsu, Koji
AU - Teshima, Takanori
N1 - Funding Information:
S.M. received personal fees from Novartis, Takeda, Eisai, Daiichi Sankyo, and Celgene. K.A. reports research grants from Novartis, MSD, Asahi Kasei Pharma, Astellas, AbbVie, Alexion, Chemo-Sero-Therapeutic Research Institute, Japan Blood Products Organization, Eisai, Otsuka, Ono, Yakult, Shin Nippon Biomedical Laboratories, Kyowa Hakko Kirin, Sanofi, Shionogi, Daiichi Sankyo, Taisho, Dainippon Sumitomo, Taiho, Takeda, Mitsubishi Tanabe, Chugai, Teijin, FUJIFILM Toyoma Chemical, Eli Lilly, Nippon Kayaku, Bayer, Bristol-Myers Squibb, Mundipharma, Merck, Mochida, and Nihon Pharmaceutical, and personal fees from Novartis, CSL Behring, MSD, Asahi Kasei Pharma, Astellas Amgen, Astellas, AbbVie, Alexion, Eisai, Otsuka, Ono, Medical Review, Kyowa Hakko Kirin, Sanofi, Shionogi, Shire Japan, SymBio, Celgene, Daiichi Sankyo, Taisho, Dainippon Sumitomo, Takeda, Mitsubishi Tanabe, Chugai, Teijin, Nippon Shinyaku, Eli Lilly, Bayer, Pfizer, Bristol-Myers Squibb, Mundi Pharma, Mochida, and Janssen. K.I. reports research grants from Novartis, Eisai, Kyowa Hakko Kirin, MSD, Takeda, Janssen, Mundipharma, Chugai, AbbVie, Bayer, Ono, Gilead, Zenyaku, Celgene, Solasia, Symbio, Astellas, Astellas Amgen, and Daiichi Sankyo, and personal fees from Kyowa Hakko Kirin, MSD, Takeda, Janssen, Bristol-Myers Squibb, Dainippon Sumitomo, Mundipharma, Nihon Mediphysics, Chugai, Astra Zeneca, AbbVie, Bayer, Ono, and Celgene. T.T. reports research grants and personal fees from Novartis. K.T. and T.F. are employees of Novartis. All other authors declare no competing interests.
Funding Information:
We thank the patients and their families, the study investigators, and the study-site personnel for their participation and contribution to this study. We thank Kazuto Natsume for analyzing and interpreting the cellular kinetics data. We thank Rama Mylapuram (Novartis Healthcare Pvt. Ltd.) for medical editorial assistance with this manuscript.
Funding Information:
This study was sponsored by Novartis Pharmaceuticals Corporation and Novartis Pharma K.K. Acknowledgements
Publisher Copyright:
© 2020, The Author(s).
PY - 2020/9/1
Y1 - 2020/9/1
N2 - 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.
AB - 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.
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U2 - 10.1007/s10147-020-01699-6
DO - 10.1007/s10147-020-01699-6
M3 - Article
C2 - 32448949
AN - SCOPUS:85085298698
SN - 1341-9625
VL - 25
SP - 1736
EP - 1743
JO - International Journal of Clinical Oncology
JF - International Journal of Clinical Oncology
IS - 9
ER -