Background: Ciltacabtagene autoleucel (cilta-cel) and idecabtagene vicleucel (ide-cel) have transformed the treatment landscape of relapsed/refractory multiple myeloma (RRMM). Given their recent regulatory approval and limited availability, mainly due to logistical issues, real-world data remain scarce. Methods: A retrospective study was conducted using the TriNetX database, identifying adult patients with RRMM treated with either cilta-cel or ide-cel. The clinical outcomes evaluated included overall survival (OS), progression-free survival (PFS), as well as the safety profile. Results: A total of 697 patients treated with cilta-cel and 575 with ide-cel were identified. The median age was 65 and 67 years, with ~16% being Black/African American. The 12-month OS was 89.6% for cilta-cel and 86.0% for ide-cel. In a descriptive subgroup analysis, renal impairment (eGFR < 60 mL/min/1.73 m2) seemed to be associated with significantly inferior OS in both cohorts (HR = 3.66, p < 0.001 for cilta-cel; HR = 1.73, p = 0.003 for ide-cel). Conversely, prior anti-CD38 exposure did not seem to impact survival in any of the two treatment groups. Any-grade CRS occurred in 45.9% (cilta-cel) and 41.8% (ide-cel), while any-grade ICANS was observed in 15.4% and 11.8%, respectively. Severe (grade ≥ 3) ICANS remained rare (<3%) in both cohorts. Hematologic toxicity was prevalent, with grade ≥ 3 neutropenia occurring in 76.0% (cilta-cel) and 68.0% (ide-cel). Notably, any-grade infections (28.5–40.1%) and hypogammaglobulinemia (41.1–43.1%) were frequent, highlighting a significant long-term immunosuppressive burden. Conclusions: In these real-world cohorts, both approved CAR T-cell therapies demonstrated favorable survival outcomes. While the incidence of severe hematologic and immune-related toxicities was high, these findings are compatible with published data from clinical trials and it seems that the clinical utility of these drugs overcomes the adverse safety profile.
Filippatos et al. (Fri,) studied this question.