萩原　將太郎
   Department   School of Medicine(Tokyo Women's Medical University Hospital), School of Medicine
   Position  
Article types Original article
Language English
Peer review Peer reviewed
Title Phase 2 results of idecabtagene vicleucel (ide-cel, bb2121) in Japanese patients with relapsed and refractory multiple myeloma.
Journal Formal name：International journal of hematology
Abbreviation：Int J Hematol
ISSN code：18653774/09255710
Domestic / ForeginForegin
Volume, Issue, Page pp.in press
Author and coauthor Minakata Daisuke†, Ishida Tadao, Ando Kiyoshi, Suzuki Rikio, Tanaka Junji, Hagiwara Shotaro, Ananthakrishnan Revathi, Kuwayama Shigeki, Nishio Mitsufumi, Kanda Yoshinobu, Suzuki Kenshi
Publication date 2023/01
Summary 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