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