ハギワラ　シヨウタロウ   Hagiwara Shiyoutarou   萩原　將太郎    所属   医学部 医学科（東京女子医科大学病院）    職種   非常勤講師
論文種別	原著
言語種別	英語
査読の有無	査読あり
表題	Phase 2 results of idecabtagene vicleucel (ide-cel, bb2121) in Japanese patients with relapsed and refractory multiple myeloma.
掲載誌名	正式名：International journal of hematology 略　 称：Int J Hematol ISSNコード：18653774/09255710
掲載区分	国外
巻・号・頁	pp.in press
著者・共著者	Minakata Daisuke†, Ishida Tadao, Ando Kiyoshi, Suzuki Rikio, Tanaka Junji, Hagiwara Shotaro, Ananthakrishnan Revathi, Kuwayama Shigeki, Nishio Mitsufumi, Kanda Yoshinobu, Suzuki Kenshi
発行年月	2023/01
概要	BACKGROUND:In the phase 2 KarMMa trial, patients with relapsed/refractory multiple myeloma (RRMM) achieved deep and durable responses with idecabtagene vicleucel (ide-cel), a B-cell maturation antigen-directed chimeric antigen receptor (CAR) T cell therapy. Here we report a sub-analysis of the Japanese cohort of KarMMa.METHODS:Adult patients with RRMM who had received  ≥ 3 prior treatment regimens, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody, and had disease refractory to last treatment received ide-cel at a target dose of 450 × 106 CAR positive T cells.RESULTS:Nine patients were treated with ide-cel. The overall response rate was 89% (median follow-up, 12.9 months). The best overall response was stringent complete response in 5 patients (56%), very good partial response in 3 (33%), and stable disease in 1. Median duration of response was not reached. All patients experienced grade ≤ 2 cytokine release syndrome and one patient experienced grade 2 neurotoxicity, but all resolved. Two patients died, one each from plasma cell myeloma and general health deterioration.CONCLUSION:Ide-cel yielded deep, durable responses with a tolerable and predictable safety profile in Japanese patients with RRMM. These results are similar to those of the non-Japanese population in KarMMa.
DOI	10.1007/s12185-023-03538-6
PMID	36690910