Real-World Description of Non-ICANS Neurologic Events Among Patients with Relapsed or Refractory Multiple Myeloma Treated with Ciltacabtagene Autoleucel Using Two Large US Databases.
Real-World Description of Non-ICANS Neurologic Events Among Patients with Relapsed or Refractory Multiple Myeloma Treated with Ciltacabtagene Autoleucel Using Two Large US Databases.
Where did the research take place?
The study site has not been established. Author addresses may differ from where the research occurred.
US · Author affiliation · country only
Division of Blood and Marrow Transplantation and Cellular Therapy, Stanford University, Stanford, CA, USA.Location evidence
Toronto, CA · Author affiliation
Analysis Group ULC, Toronto, ON, Canada.Location evidence
Montréal, CA · Author affiliation
Analysis Group ULC, Montreal, QC, Canada.Location evidence
Phoenix, US · Author affiliation
Division of Hematology and Medical Oncology, Mayo Clinic in Arizona, Phoenix, AZ, USA.Location evidence
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Original abstract
INTRODUCTION: Ciltacabtagene autoleucel (cilta-cel) is a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy approved in the USA for relapsed or refractory multiple myeloma (RRMM) as early as following first relapse, based on pivotal CARTITUDE-1 (≥ 4 prior lines of therapy [LOT]) and CARTITUDE-4 (1-3 prior LOT) trials, which reported high response rates and prolonged survival. In CARTITUDE-1 and CARTITUDE-4, rates of all-grade parkinsonism were 6% and < 1%, respectively, while rates of cranial nerve palsy were 3% and 9%, respectively. This study aimed to characterize new-onset nonimmune effector cell-associated neurotoxicity syndrome (non-ICANS) neurologic events (NEs) among patients with RRMM receiving cilta-cel after 1-3 or ≥ 4 prior LOT. METHODS: This retrospective study used two real-world data sources: open and closed insurance claims from the Komodo Research Database (February 2021-November 2024), and electronic medical records from Loopback Analytics (February 2021-December 2024). New-onset non-ICANS NEs, including parkinsonism, cranial nerve palsy, and Guillain-Barré syndrome, were assessed from cilta-cel infusion until the end of clinical activity, death, or end of data availability. Analyses were conducted separately by database and stratified by LOT. RESULTS: In patients with 1-3 prior LOT (Komodo: 124; Loopback: 79), over a median follow-up of 3.4-3.5 months, cranial nerve palsy occurred in 5.6% and 5.1% in Komodo and Loopback, respectively, with no parkinsonism or Guillain-Barré syndrome observed. In patients with ≥ 4 prior LOT (Komodo: 524; Loopback: 191), over a median follow-up of 13.2-13.3 months, parkinsonism occurred in 1.0% in both databases, cranial nerve palsy in 4.6% and 1.0%, and Guillain-Barré syndrome in 0.2% and 0.5% in Komodo and Loopback, respectively. CONCLUSIONS: In this real-world study, rates of non-ICANS NEs post-cilta-cel infusion across two databases were comparable to or lower than prior trials or real-world studies, reinforcing the favorable risk-benefit profile of cilta-cel in routine practice. Graphical Abstract available for this article.