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