This study was run to characterize the real-world CAR-T patient population by describing demographic and social drivers of health (SDOH) attributes at the time of therapy initiation.
Background:
Chimeric antigen receptor (CAR) T-cell therapy has significantly superior outcomes compared to standard of care treatments, suggesting its potential use in earlier lines of therapy. Despite its clinical efficacy, however, concerns persist regarding the safety and cost-effectiveness of CAR-T therapy, particularly as they relate to treatment-associated toxicities and the overall cost of care.
To date, real-world evidence on adverse events (AEs) has been limited to case reports and institutional retrospective studies, many of which lack tracking of secondary primary malignancies and all-cause mortality1. This analysis utilizes real-world claims data (RWD) to address this knowledge gap by characterizing patients receiving CAR-T therapy and comparing rates of key clinical outcomes between and among different CAR-T products.
Study overview:
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A retrospective cohort study was conducted using PurpleLab® CLEAR longitudinal claims incurred between January 1, 2019 and June 30, 2024.
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The study cohort (N=856) included patients with at least one medical claim for multiple myeloma, lymphoma, or leukemia between January 1, 2020 and June 30, 2023.
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The patients subsequently initiated CAR-T therapy, including idecabtagene vicleucel, lisocabtagene maraleucel, ciltacabtagene autoleucel, tisagenlecleucel, brexucabtagene autoleucel, and axicabtagene ciloleucel.
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Patients were required to be continuously eligible to receive medical and pharmacy benefits for at least 12 months pre-diagnosis.
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Patients were excluded from the study cohort if they were diagnosed with any primary or secondary cancer—including t-cell/NK-cell malignancy and excluding non-melanoma skin cancer—during the 12-month baseline period.
The findings underscore key attributes of the typical CAR-T patient—often not a diverse sub-population—and highlight the need for RWD to evaluate how demographics, SDOH, and treatment effects influence patient selection, complications, and treatment response.
RWD can also clarify variation in outcomes across CAR-T therapies, providing insight into differences in complications and potentially suggesting long-term effectiveness while informing more equitable patient management.
This analysis addresses a knowledge gap by providing product-specific safety and survival data that extend beyond the controlled environment of clinical trials, offering valuable baseline evidence to guide treatment decisions and support healthcare systems in modeling the cost-effectiveness and safety profile of these therapies.
Download the full research poster below for more detail.