Ide-cel Demonstrates Favorable Infection Safety Profile Compared to Other BCMA-Targeted Therapies in Multiple Myeloma
New data presented at the 2025 International Myeloma Society Annual Meeting suggests ide-cel (Abecma) may carry a lower risk of infection-related adverse events compared to other BCMA-directed therapies for multiple myeloma (MM). This is notably notable for patients who are already immunocompromised or have existing health conditions. The findings, based on analysis of the Food and Drug Management’s (FDA) Adverse Event Reporting System (FAERS), offer valuable insights into the real-world safety profiles of these critical treatments.
The Growing Landscape of BCMA-Directed Therapies
Bispecific antibodies and CAR T-cell therapies targeting BCMA have revolutionized treatment for multiple myeloma. Though, these powerful therapies can also suppress the immune system, increasing vulnerability to infections. Understanding the nuances of each treatment’s safety profile is crucial for informed decision-making.
Traditionally, safety data relies heavily on controlled clinical trials. But these trials often involve a limited and highly selected patient population.FAERS provides a broader view, capturing data from a much larger, more diverse group of patients post-market approval. This expanded dataset offers increased statistical power to identify and characterize potential toxicities.
How the Study Was Conducted
Researchers analyzed FAERS data from the first quarter of 2021 through the fourth quarter of 2024, focusing on reports of infection-related adverse events (AEs) in patients receiving:
* Ide-cel (Abecma)
* Ciltacabtagene autoleucel (cilta-cel; Carvykti)
* Teclistamab (Teclavy)
* Elranatamab (elrexfio)
Thay specifically looked at infection-related non-relapse mortality (NRM) and hospitalizations, defining NRM as deaths not due to myeloma progression, with further confirmation of an infectious cause. to account for varying treatment timelines, sensitivity analyses were performed, limiting the data to two years post-approval for each drug.
The team then calculated reporting odds ratios (RORs) to compare the treatments.An ROR greater than 1 indicates a higher reporting frequency for that event compared to ide-cel.
Key Findings: Ide-cel shows a Promising Safety Signal
The analysis included 4,809 AE reports overall. Here’s a breakdown of the key findings:
* Overall Infection Reports: teclistamab, elranatamab, and cilta-cel all showed substantially higher frequencies of infection reports compared to ide-cel.
* teclistamab: ROR 3.81 (95% CI, 2.51-5.77)
* Elranatamab: ROR 5.67 (95% CI, 3.53-9.10)
* Cilta-cel: ROR 1.78 (95% CI, 1.16-2.73)
* Infection-Related NRM: Teclistamab and elranatamab were associated with a statistically higher risk of infection-related NRM compared to ide-cel.
* Teclistamab: ROR 4.02 (95% CI, 1.43-11.32)
* Elranatamab: ROR 5.57 (95% CI, 1.76-17.65)
* Ide-cel and cilta-cel showed comparable rates (ROR 1.01, 95% CI, 0.33-3.12).
* Infection-Related Hospitalizations: Similar trends were observed for hospitalizations due to infection.
* Teclistamab: ROR 3.44 (95% CI, 2.03-5.83)
* Elranatamab: ROR 5.65 (95% CI, 3.14-10.19)
* Cilta-cel: ROR 1.53 (95% CI, 0