Abstract
MM-504 Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome in Relapsed and Refractory Multiple Myeloma Using the FAERS Database
Clinical lymphoma, myeloma and leukemia, Vol.24(Supplement 1), pp.S564-S564
09/2024
DOI: 10.1016/S2152-2650(24)01693-8
Abstract
Chimeric antigen receptor T-cell therapy (CAR-T) and T-cell engager antibody (TCE) have revolutionized the treatment of RRMM. In an immune effector cell therapy recipient, immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) is a life-threatening hyper-severe inflammatory state due to uncontrolled activation of natural killer cells and cytotoxic T lymphocytes characterized by cytopenia, coagulopathy, reduced fibrinogen, transaminasemia, and hyperferritinemia.
We conducted a retrospective postmarketing pharmacovigilance inquiry using the FDA Adverse Event Reporting System (FAERS) database and the Medical Dictionary for Regulatory Activities (MEDRA). We examined adverse effects associated with CAR-T and TCE since their FDA approval in the US and non-US populations using R software. The data were accessed on March 1, 2024, to analyze the incidence of IEC-HS associated with BCMA-targeting TCE, teclistamab, elranatamab, GPRC5D-targeting talquetamab, and 2 CAR T-cell products (idecabtagene vicleucel [ide-cel] and ciltacabtagene autoleucel [cilta-cel]).
A total of 2690 adverse events were reported in FAERS: cilta-cel (n=837, 31.1%), ide-cel (n=651, 24.2%), talquetamab (n=159, 5.9%) teclistamab (n=791, 29.4%) and elranatamab (n=252, 9.3%). We identified 38 IEC-HS events, of which 89.4 % (n=34) were due to CAR-T and 10.5% (n=4) were due to GPRC5D bispecific antibody. The highest incidence of therapy-specific IEC-HS was with ide-cel (n=15, 2.3%), followed by cilta-cel (n=19, 2.2%) and teclistamab (n=4, 0.5%). Newer drugs, such as talquetamab and elranatamab, had no HLH-HS events reported to date. Isolated IEC-HS (n=10, 26.3%), combined IEC-HS with CRS (n=17, 44.7%), IEC-HS with ICANS (n=1, 2.6%), and IEC-HS, ICANS, and CRS (n=10, 26.3%) were reported. Teclistamab-associated IEC-HS had the highest mortality rate (n=3, 75%), followed by ide-cel (n=9, 60%) and cilta-cel (n=8, 42.1%). 36.8% (n=14) of cases were associated with infections, with a mortality rate of 85.7% (n=12). Ide-cel recipients had a higher rate of IEC-HS–associated infections (64.2% [n=14]), followed by cilta-cel (28.5% [n=4]), and teclistamab (7.1 % [n=1]).
The incidence of IEC-HS is lower in MM TCE than CAR-T. While there were no reported cases of IEC-HS with newer therapies (talquetamab and elranatamab), longer follow-up is needed. CAR-T and TCE can result in fatal adverse events, including IEC-HS, with increased mortality secondary to infections.
Details
- Title: Subtitle
- MM-504 Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome in Relapsed and Refractory Multiple Myeloma Using the FAERS Database
- Creators
- Fathima Shehnaz Ayoobkhan - Trinity Health Oakland HospitalRaeef Rahman - University of Kansas Medical CenterAhmad Iftikhar - United States Myeloma Innovations Research Collaborative (USMIRC), Kansas, USARaabia Qureshi - University of Missouri–Kansas CityNahid Suleman - University of Kansas Medical CenterWilliam Wesson - University of Kansas Medical CenterMuhammad Umair - United States Myeloma Innovations Research Collaborative (USMIRC), Kansas, USAEvguenia Ouchveridze - University of Kansas Medical CenterAl-Ola Abdallah - United States Myeloma Innovations Research Collaborative (USMIRC), Kansas, USAShahzad Raza - Cleveland ClinicHira Shaikh - University of IowaShebli Atrash - Levine Cancer InstituteJoseph McGuirk - University of Kansas Medical CenterHamza Hashmi - Memorial Sloan Kettering Cancer CenterDanai Dima - Cleveland ClinicFiaz Anwer - United States Myeloma Innovations Research Collaborative (USMIRC), Kansas, USABriha Ansari - Johns Hopkins UniversityNausheen Ahmed - United States Myeloma Innovations Research Collaborative (USMIRC), Kansas, USA
- Resource Type
- Abstract
- Publication Details
- Clinical lymphoma, myeloma and leukemia, Vol.24(Supplement 1), pp.S564-S564
- Publisher
- Elsevier Inc
- DOI
- 10.1016/S2152-2650(24)01693-8
- ISSN
- 2152-2650
- Language
- English
- Date published
- 09/2024
- Academic Unit
- Internal Medicine
- Record Identifier
- 9984699048702771
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