At the American Society of Hematology (ASH) Annual Meeting 2025, held in Orlando, Florida and online from 7 to 10 December, the updated results from the multicentre, open-label, pivotal Phase II iMMagine-1 clinical trial were presented. This trial evaluated the safety and efficacy of Arcellx and Gilead’s anitocabtagene autoleucel (anito-cel), an investigational autologous D-domain B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR)-T cell therapy, in patients with relapsed or refractory (R/R) multiple myeloma (MM) who were triple-class exposed to a proteasome inhibitor, an immunomodulatory drug and an anti-CD38 monoclonal antibody.
The trial enrolled 117 heavily pretreated R/R MM patients. Patients received a single infusion of anito-cell with a target dose of 115×10⁶ CAR-positive viable T cells. The overall response rate was 96%, and the complete response (CR)/stringent complete response (sCR) rate was 74%, with a median time to first response of 4.8 months. At a median follow-up of 15.9 months, median time to sCR or CR was 3.2 months, as assessed by an independent review committee using 2016 International Myeloma Working Group criteria.
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Minimal residual disease (MRD), as assessed by next-generation sequencing, showed that among evaluable patients, 95% (91/96) achieved MRD negativity at 10⁻⁵ sensitivity, with a median time of 1 month (range 0.9 to 6.4 months), and 78% (68/87) achieved MRD negativity at 10⁻⁶ sensitivity. A Kaplan–Meier analysis showed 12, 18 and 24-month progression-free survival (PFS) rates of 82.1%, 67.4% and 61.7% respectively, and overall survival (OS) rates of 94%, 88% and 83%, respectively. The median PFS and OS were not reached. Anito-cel showed a manageable safety profile, with no grade 3/4 treatment-emergent adverse events. Cytopenias were the most common adverse event. A total of 83% of patients experienced no or grade 1 cytokine release syndrome. Grade 2 or lower immune effector cell-associated neurotoxicity (ICANS) affected 8% of patients, with one grade 3 case. No delayed neurotoxicities, immune effector cell-related enterocolitis, or secondary T cell malignancies were observed.
Anito-cel will directly compete with Johnson & Johnson (J&J)/Legend’s Carvykti (ciltacabtagene autoleucel). According to GlobalData’s Multiple Myeloma: Eight-Market Drug Forecast and Market Analysis report, anito-cel sales are projected to reach $658 million by 2032 across the eight major markets (8MM: Australia, Canada, France, Germany, Italy, Spain, the UK and the US) compared with an estimated $6.3 billion for Carvykti. Arcellx and Gilead are also conducting the Phase III iMMagine-3 trial of anito-cel in patients with R/R MM in the second line and later treatment settings. The iMMagine-1 trial will support anito-cel’s FDA submission, whereas the Phase III iMMagine-3 study in second-line and later R/R MM is aimed at label expansion into earlier treatment lines. If iMMagine-3 also delivers positive, statistically significant results versus the standard of care, this would further differentiate anito-cel clinically and place it in a highly competitive commercial position in the R/R MM market. Anito-cel’s high complete response rate and an impressive safety profile, possibly due its unique D-domain binder, suggests that anito-cel has credible best-in-class potential and could ultimately be delivered more broadly through selected community-based centres.
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