KarMMA-2 Cohort 2B: Ide-cel in early relapse clinical high-risk MM

Analysis of Cohort 2B of the KarMMa-2 trial (NCT03601078) evaluating the efficacy and safety of idecabtagene vicleucel (ide-cel) in patients with high-risk, early-relapse multiple myeloma (MM) who did not receive front-line autologous stem cell transplantation (ASCT) was presented at EHA 2024 by Xavier Leleu. Of the 35 patients enrolled, 89% received ide-cel. The median age was 60 years, many had high-risk cytogenetics; 68% were double-class refractory, and 16% were triple-class refractory.

In patients with newly diagnosed MM that progressed <18 months after treatment initiation, a single ide-cel infusion demonstrated a favorable benefit–risk profile with frequent, deep, durable responses and a manageable safety profile.

The overall response rate (ORR) was 94%, with a complete response rate (CR) of 71%; high minimal residual disease (MRD) negativity rates were observed at 12 and 24 months.

The median duration of response (DOR), progression-free survival (PFS), and overall survival (OS) were not reached; PFS rates were 70% at 12 months and 63% at 24 months; OS rates were 90% at 12 months and 79% at 24 months.

Grade 3/4 adverse events were experienced by 94% of patients, primarily neutropenia and thrombocytopenia; infections were identified in 19% of patients; cytokine release syndrome was observed in 84% of patients, with no Grade ≥3 cases.

These findings suggest that ide-cel offers a promising treatment for high-risk, early-relapse MM, potentially altering treatment paradigms for patients who are not candidates for ASCT.