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2024-03-21T15:17:21.000Z

European Commission approves idecabtagene vicleucel for the treatment of triple-class-exposed RRMM

Mar 21, 2024
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Learning objective: After reading this article, learners will be able to cite a new clinical development in relapsed/refractory MM

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On March 20, 2024, the European Commission granted approval to idecabtagene vicleucel (ide-cel) for the treatment of triple-class-exposed relapsed/refractory multiple myeloma (RRMM) with two or more prior therapies, including an immunomodulatory agent (IMiD), proteasome inhibitor (PI), and an anti-CD38 antibody with subsequent disease progression.1

In August, 2021, ide-cel was granted approval by the European Commission for the treatment of RRMM treated with three or more prior therapies, including an IMiD, PI, and anti-CD38 monoclonal antibody.2 This latest approval for ide-cel marks the first chimeric antigen receptor (CAR) T-cell therapy approved in earlier lines of therapy. This approval is based on data from the phase III KarMMa-3 (NCT03651128) clinical trial.1

The Multiple Myeloma Hub has previously reported the study design of KarMMa-3 and latest updates from ASH 2023.

KarMMa-3 – pivotal data1

  • At a median follow up of 18.6 months, treatment with ide-cel demonstrated a significant increase in median progression-free survival (PFS) at 13.8 months vs 4.4 months in the comparator standard-of-care arm (hazard ratio: 0.49; 95% confidence interval [CI]: 0.38–0.63; p < 0.0001).
  • The overall response rate (ORR) observed in the ide-cel arm was 71.3%, with a complete response or greater (≥CR) rate of 43.7% vs an ORR of 42.4% and ≥CR rate of 5.3% with standard-of-care treatment.
  • Median overall survival was higher in the ide-cel cohort at 41.4 months vs 37.9 months.
  • The safety profile observed with ide-cel was comparable to the established profile in later lines of therapy (Figure 1).

Figure 1. Incidence of CRS and neurotoxicity* 

CRS, cytokine release syndrome.
*Data from Bristol Myers Squibb.1

 

  1. Bristol Myers Squibb. Bristol Myers Squibb’s Abecma (idecabtagene vicleucel) Becomes First CAR T Cell Therapy Approved in the European Union in Earlier Lines for Triple-Class Exposed Relapsed and Refractory Multiple Myeloma. https://news.bms.com/news/corporate-financial/2024/Bristol-Myers-Squibbs-Abecma-idecabtagene-vicleucel-Becomes-First-CAR-T-Cell-Therapy-Approved-in-the-European-Union-in-Earlier-Lines-for-Triple-Class-Exposed-Relapsed-and-Refractory-Multiple-Myeloma/default.aspx. Published Mar 20, 2024. Accessed Mar 21, 2024.
  2. Bristol Myers Squibb. Bristol Myers Squibb Receives European Commission Approval for Abecma (Idecabtagene Vicleucel), the First Anti-BCMA CAR T Cell Therapy for Relapsed and Refractory Multiple Myeloma. https://news.bms.com/news/details/2021/Bristol-Myers-Squibb-Receives-European-Commission-Approval-for-Abecma-Idecabtagene-Vicleucel-the-First-Anti-BCMA-CAR-T-Cell-Therapy-for-Relapsed-and-Refractory-Multiple-Myeloma/default.aspx. Published Aug 19, 2021. Accessed Mar 21, 2024.

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