FAERS Data suggest Ide-Cel Associated With Fewer Infections Than Newer Multiple Myeloma Therapies
TORONTO - an analysis of the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) indicates that ide-cel (Abecma) may be linked to a lower incidence of infection-related adverse events compared to teclistamab (teclavy), elranatamab (Elrexfio), and ciltacabtagene autoleucel (cilta-cel; Carvykti), all treatments for multiple myeloma (MM). The findings, presented at the 2025 International Myeloma Society Annual Meeting, highlight potential differences in safety profiles among BCMA-directed therapies.
Researchers analyzed case report forms (CRFs) from the first quarter of 2021 through the fourth quarter of 2024,encompassing 4809 adverse event (AE) reports in MM patients. Specifically, 689 reports were associated with ide-cel, 1732 with teclistamab, 363 with elranatamab, and 2025 with cilta-cel.
Disproportionality analyses, using reporting odds ratios (RORs), revealed considerably higher frequencies of infection reports with teclistamab (ROR 3.81 [95% CI, 2.51-5.77]), elranatamab (ROR 5.67 [95% CI, 3.53-9.10]), and cilta-cel (ROR 1.78 [95% CI, 1.16-2.73]) compared to ide-cel. Sensitivity analyses, restricting CRF analysis to two years post-approval for each drug, yielded similar results.
Further analysis focusing on infection-related non-relapse mortality (NRM) showed statistically higher frequencies with teclistamab (ROR 4.02 [95% CI, 1.43-11.32]) and elranatamab (ROR 5.57 [95% CI, 1.76-17.65]) versus ide-cel. The ROR for ide-cel and cilta-cel was 1.01 (95% CI, 0.33-3.12). Similar trends were observed for infection-related hospitalizations: teclistamab (ROR 3.44 [95% CI, 2.03-5.83]), elranatamab (ROR 5.65 [95% CI, 3.14-10.19]), and cilta-cel (ROR 1.53 [95% CI, 0.88-2.65]).
“This highlights the importance of integrating safety profiles into treatment decisions to optimize outcomes and reduce risks,” the authors concluded. The analysis underscores the clinical relevance of considering safety profiles, especially regarding infection risk, when selecting BCMA-directed therapies for immunocompromised or comorbid MM patients.
REFERENCE
Sidana S, Patel K, Dhandra D, et al.Infections in patients (pts) with multiple myeloma (Mm) treated with BCMA-directed CAR T cell therapies and bispecific antibodies: Analysis of the FDA Adverse Event Reporting System (FAERS). 2025 International Myeloma Society Annual meeting. September 17, 2025, to September 20, 2025. Toronto, Canada.abstract PA-067
