Safety and Outpatient Potential of Anito-Cel in Multiple Myeloma

EP: 1.iMMagine-1: Anito-Cel Shows Efficacy in R/R Multiple Myeloma

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EP: 2.Safety and Outpatient Potential of Anito-Cel in Multiple Myeloma

Krina Patel, MD, MSc, associate professor in the Department of Lymphoma/Myeloma in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, highlights updated safety and exploratory efficacy insights from the iMMagine-1 trial of anito-cel in relapsed or refractory multiple myeloma that were presented at ASH 2025, with a particular focus on tolerability, CAR T-cell design, and unmet needs for future analyses. Overall, the safety profile of anito-cel continues to appear favorable compared with other CAR T-cell and continuous therapy options in this heavily pretreated population.

Cytokine release syndrome (CRS) was largely low grade, consistent with broader CAR T-cell experience in myeloma. Most patients experienced grade 1 CRS, while notably 15% had no CRS at all. Higher-grade CRS or ICANS events were uncommon, and this low toxicity burden enabled outpatient administration in approximately 8% of treated patients—an important consideration for real-world feasibility. Serious infections were also relatively infrequent, with grade 3 or 4 infections reported in only 9% of patients. This rate compares favorably with continuous myeloma therapies.

With longer follow-up of nearly 16 months, no cases of delayed neurotoxicity—including Parkinsonian syndromes, Guillain-Barré syndrome, cranial nerve palsies, or enterocolitis—have been observed, addressing a key concern with CAR T-cell therapies in multiple myeloma. These findings further support the durability of the therapy’s safety profile over time.

Patel also explained how the unique construct of anito-cel may contribute to these outcomes. Its D-domain binding structure, a small protein that targets BCMA, allows for more efficient CAR T-cell transduction and a cleaner cell product, enabling lower effective cell doses without compromising efficacy. This design may also promote faster disengagement from the target, potentially reducing inflammation and toxicity.

Finally, the discussion underscores the need for deeper subset analyses to better understand predictors of earlier progression, particularly among patients with high-risk cytogenetics or extramedullary disease, as additional data from iMMagine-1 continue to mature.