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    Cellular and T cell engager Immunotherapy

    (OA-65) Farorable Outcome of Relapsed/Refractory Multiple Myeloma treated with Idecabtagene Vicleucel (Ide-cel) Chimeric Antigen Receptor (CAR) T-Cell Therapy; IFM experience from the Descar-T Registry

    Thursday, September 18, 2025
    15:00 - 15:08 East Coast USA Time
    Location: Hall FG
    Introduction: Ide-cel was first available in France since 04/2021 through the Early Access Program for treatment of patients (pts) with relapsed/refractory multiple myeloma (RRMM) having received at least 3 therapies including a proteasome inhibitor, an immunomodulatory drug and an anti-CD38 monoclonal antibody and then via commercial access from 11/2024. Here we present an update of characteristics and outcomes of pts enrolled in this program

    Methods:  all consecutive pts with RRMM registered in the DESCAR-T database treated with Ide-cel from 04/2021 to 02/2025 were enrolled. Main objective was to analyze efficacy (response rates, PFS and OS, according to two periods: cohort A (04/2021 to 04/2023, n=175) with limited open center (n=11) and cohort B (05/2023 to 02/2025, n=596) with unlimited access. Secondary objective was safety including CRS, ICAN, cytopenia, infection, and SPM

    Results:  915 pts were included of whom 115 (13%) were not infused. Median age of the 771 infused pts (58% male) was 66 years (range: 29-85) and was superior in cohort B (66.9 y) as compared to cohort A (61.7 y). Median Nb of prior lines of therapies was 3 (range: 0-13). More pts had received <2 lines in cohort B (122/596 [20%] vs 5/175 [3%], p< 0.0001). Revised International Staging System (R-ISS) stage 3 was noted in 21% of pts, 37% had high risk cytogenetic abnormalities defined by del(17p) or t(4;14), and high tumor burden (>30% BMPCs) was present in 53%, in both cohorts. Triple- ( 73%) and penta-refractory pts ( 22%) were lower in cohort B (69% vs. 83%, p< 0.0001 and 19% vs. 31%, p=0.01, respectively). Extramedullary disease (EMD) was observed 10% of pts 8% in cohort B vs. 16% in cohort A).   162 pts (21%) did not meet at least one of the KarMMa inclusion criteria.  630 pts (82%) had bridging therapy of which 188(34%) responded. Median vein-to-vein time was 56 days (range: 39-357),  (61 d in cohort A vs 55 d in B, p< 0.0001). In both cohorts, best ORR at M3 post Ide-cel was 89% (n=638), including CR in 42%. 264 pts (34%) progressed after Ide-cel and 139 pts (18%) died, mostly of disease progression (73%). With a median follow-up of 11.8 m, median PFS was 14.8 m (95% CI, 12.6 - 16.8), similar in both cohorts (HR: 0.85, p=0.19). Median OS was 38.9 m (95% CI, 34.2 – NR). EMD, ISS, prior bispecific and penta-refractoriness were negative factors for PFS and OS. CRS occurred in 677 (88%) pts (3% gr ≥3). ICAN occurred in 81 (11%) pts (2% with gr ≥3). Persistent grade ≥3 toxicities  at M1 were noted in  28% to 49% of pts. Infections in the first 6 m after Ide-cel occurred in 187 (24%) pts (grade ≥3: 33 [18%]). 24 pts developed SPM

    Conclusions:

    This study confirms safety and efficacy of Ide-cel in pts with RRMM in real- world settings across the 4-year period. Response rates, PFS and safety compares favorably to those reported in the registration trial and the real-world studies in the US.  During both periods, selection of less advanced pts leads to a prolonged PFS and OS, never reported to date outside of clinical trial.