REAL-WORLD COMPARISON OF CRS AND ICANS SEVERITY ACROSS SIX COMMERCIAL CAR-T THERAPIES
Author(s)
Allison R. Brosso, BA1, Douglas Londono, PhD1, Scott L. DuVall, PhD2;
1PurpleLab, Wayne, PA, USA, 2PurpleLab Healthcare Analytics, Taylorsville, UT, USA
1PurpleLab, Wayne, PA, USA, 2PurpleLab Healthcare Analytics, Taylorsville, UT, USA
OBJECTIVES: Chimeric Antigen Receptor-T (CAR-T) cell therapies are effective but carry risks of Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), contributing to healthcare costs and resource utilization. As CAR-T therapy expands, understanding real-world toxicity profiles across products is increasingly important. This study examined variation in CRS and ICANS severity among CAR-T therapies
METHODS: We conducted a retrospective cohort study using de-identified U.S. medical and pharmacy claims from the PurpleLab® CLEAR database (January 1, 2019, and September 30, 2024). Adult patients with hematological malignancies treated with one of six FDA-approved CAR-T products (cilta-cel, ide-cel, axi-cel, brexu-cel, liso-cel, and tisa-cel) were included. The index date was CAR-T infusion, with a one-year look-back for the primary cancer diagnosis. Outcomes were assessed through death, disenrollment, or study end, with ≥12 months of follow-up. Incidence and severity of CRS and ICANS were evaluated.
RESULTS: Most CRS events were mild (Grade 1-2) across all products. Idecabtagene vicleucel and ciltacabtagene autoleucel showed the highest CRS incidence, while tisagenlecleucel and lisocabtagene maraleucel had fewer high-grade events. ith brexucabtagene autoleucel and axicabtagene ciloleucel showing higher rates of Grade 3 neurotoxicity; however, differences were not statistically significant (χ² p>0.05). High-grade events were rare overall.
CONCLUSIONS: While mild-to-moderate toxicities are common in real-world settings, specific CAR-T products have distinct toxicity profiles. Some products are linked to higher CRS incidence while others are associated with more severe neurotoxicity. These findings provide important clinical insights and highlight the need for specific management strategies to reduce severe complications.
METHODS: We conducted a retrospective cohort study using de-identified U.S. medical and pharmacy claims from the PurpleLab® CLEAR database (January 1, 2019, and September 30, 2024). Adult patients with hematological malignancies treated with one of six FDA-approved CAR-T products (cilta-cel, ide-cel, axi-cel, brexu-cel, liso-cel, and tisa-cel) were included. The index date was CAR-T infusion, with a one-year look-back for the primary cancer diagnosis. Outcomes were assessed through death, disenrollment, or study end, with ≥12 months of follow-up. Incidence and severity of CRS and ICANS were evaluated.
RESULTS: Most CRS events were mild (Grade 1-2) across all products. Idecabtagene vicleucel and ciltacabtagene autoleucel showed the highest CRS incidence, while tisagenlecleucel and lisocabtagene maraleucel had fewer high-grade events. ith brexucabtagene autoleucel and axicabtagene ciloleucel showing higher rates of Grade 3 neurotoxicity; however, differences were not statistically significant (χ² p>0.05). High-grade events were rare overall.
CONCLUSIONS: While mild-to-moderate toxicities are common in real-world settings, specific CAR-T products have distinct toxicity profiles. Some products are linked to higher CRS incidence while others are associated with more severe neurotoxicity. These findings provide important clinical insights and highlight the need for specific management strategies to reduce severe complications.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
CO100
Topic
Clinical Outcomes
Topic Subcategory
Clinical Outcomes Assessment
Disease
SDC: Oncology