A comprehensive analysis of real-world safety data has revealed that idecabtagene vicleucel (ide-cel, Abecma) demonstrates a more favorable infection-related safety profile compared to other B-cell maturation antigen (BCMA)-directed therapies in multiple myeloma patients. The findings, presented at the 2025 International Myeloma Society Annual Meeting, underscore critical safety differences among these advanced cancer treatments.
FAERS Database Analysis Methodology
Researchers conducted a retrospective analysis using the FDA Adverse Event Reporting System (FAERS), a post-marketing safety surveillance database that captures adverse events for all FDA-approved drugs in the United States. The FAERS database provides long-term drug safety follow-up with data from a broader patient population than clinical trials, offering increased statistical power to detect and characterize toxicities.
The analysis examined real-world infection-related adverse events in multiple myeloma patients receiving BCMA-directed chimeric antigen receptor (CAR) T-cell and bispecific antibody therapies. The assessment included patients treated with ide-cel, ciltacabtagene autoleucel (cilta-cel; Carvykti), teclistamab (Teclavy), and elranatamab (Elrexfio).
Significant Infection Risk Differences Identified
The study analyzed all case report forms from Q1 2021 to Q4 2024, encompassing 4,809 adverse event reports in multiple myeloma. Of these reports, 689 were associated with ide-cel, 1,732 with teclistamab, 363 with elranatamab, and 2,025 with cilta-cel.
Disproportionality analyses using reporting odds ratios (ROR) revealed significantly higher frequencies of infection reports compared to ide-cel across multiple therapies. Teclistamab showed a 3.81-fold higher infection reporting rate (ROR 3.81 [95% CI, 2.51–5.77]), while elranatamab demonstrated the highest risk with a 5.67-fold increase (ROR 5.67 [95% CI, 3.53–9.10]). Cilta-cel showed a more modest but still statistically significant 1.78-fold higher infection rate (ROR 1.78 [95% CI, 1.16–2.73]) compared to ide-cel.
Infection-Related Mortality and Hospitalization Patterns
The analysis extended beyond general infection rates to examine infection-related non-relapse mortality (NRM) and hospitalizations. Researchers defined infection-related NRM as deaths excluding those from progressive multiple myeloma, with additional filtering for infections.
For infection-related mortality, teclistamab (ROR 4.02 [95% CI, 1.43–11.32]) and elranatamab (ROR 5.57 [95% CI, 1.76–17.65]) demonstrated statistically higher frequencies compared to ide-cel. Notably, cilta-cel showed comparable infection-related mortality rates to ide-cel (ROR 1.01 [95% CI, 0.33–3.12]).
Similar patterns emerged for infection-related hospitalizations, with teclistamab showing a 3.44-fold higher rate (ROR 3.44 [95% CI, 2.03–5.83]), elranatamab demonstrating a 5.65-fold increase (ROR 5.65 [95% CI, 3.14–10.19]), and cilta-cel showing a non-significant 1.53-fold higher rate (ROR 1.53 [95% CI, 0.88–2.65]) compared to ide-cel.
Clinical Implications for Treatment Selection
The research authors emphasized the clinical significance of these findings, stating: "This retrospective analysis showed a favorable [real-world] safety profile for ide-cel vs other BCMA-directed therapies in terms of infections and infection-related NRMs and hospitalizations."
To account for differences in follow-up duration between treatments after market approval, researchers performed sensitivity analyses restricting the analysis period to two years post-approval for each drug. These sensitivity analyses yielded similar results, reinforcing the robustness of the findings.
Impact on Multiple Myeloma Treatment Decisions
The findings carry particular importance for multiple myeloma patients, who are often immunocompromised and face elevated infection risks. The authors concluded that these results "highlight the importance of integrating safety profiles into treatment decisions to optimize outcomes and reduce risks, especially infection-related burden and mortality in pts with MM who are immunocompromised or have other comorbidities."
By leveraging FAERS data, this analysis demonstrates that ide-cel may offer a more favorable infection-related safety profile compared to other BCMA therapies, particularly bispecific antibodies. For patients with multiple myeloma managing immunocompromised states or comorbidities, this distinction represents a clinically meaningful consideration for treatment planning and risk optimization.
