Phase 2 results of idecabtagene vicleucel (ide-cel, bb2121) in Japanese patients with relapsed and refractory multiple myeloma

Int J Hematol. 2023 May;117(5):729-737. doi: 10.1007/s12185-023-03538-6. Epub 2023 Jan 24.

Abstract

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.

Keywords: CAR T cell therapy; Idecabtagene-vicleucel; Japanese patients; Relapsed/refractory multiple myeloma; Triple-class exposed.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Cytokine Release Syndrome
  • Humans
  • Immunotherapy, Adoptive / adverse effects
  • Multiple Myeloma* / therapy
  • Neoplasms, Plasma Cell*
  • Receptors, Chimeric Antigen*

Substances

  • idecabtagene vicleucel
  • Receptors, Chimeric Antigen