At the 2025 European Hematology Association (EHA) Congress, held from June 12 to June 15 in Milan, Italy, updated results from the Phase II registrational iMMagine-1 study were presented, evaluating Arcellx’s anitocabtagene autoleucel (anito-cel), an autologous anti–B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T-cell therapy for relapsed or refractory (R/R) multiple myeloma (MM).
At a median follow-up of 12.6 months, the study met its primary endpoint with an objective response rate (ORR) of 97%, including a 68% complete response (CR) rate. The 12-month progression-free survival (PFS) and overall survival (OS) rates were 79% and 95%, respectively, with median PFS and OS not yet reached. 93% of patients were minimal residual disease negative. The safety profile was favourable, with cytopenias as the most common grade ≥3 adverse event, as well as low rates of cytokine release syndrome (CRS) (15%) and neurotoxicity (8%).
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Arcellx is also sponsoring the Phase III iMMagine-3 study evaluating anito-cel in R/R MM patients in the second-line or later setting. According to GlobalData’s patient-based forecast, Multiple Myeloma: Eight-Market Drug Forecast and Market Analysis, anito-cel sales are projected to reach $658 million by 2032 across the eight major markets (China, France, Germany, Italy, Japan, Spain, the UK and the US).
Anito-cel enters a competitive space that includes two approved CAR T-cell therapies: Johnson & Johnson/Legend’s Carvykti (ciltacabtagene autoleucel) and Bristol Myers Squibb’s Abecma (idecabtagene vicleucel). Both therapies are approved for patients with R/R MM after at least three previous lines of therapy. It also competes with bispecific antibodies approved in the fourth-line setting or later, including Janssen’s Tecvayli (teclistamab), Janssen’s Talvey (talquetamab) and Pfizer’s Elrexfio (elranatamab).
A key differentiator for anito-cel is its next-generation CAR construct, which incorporates a synthetic D-domain binder designed to enhance efficiency, stability and safety. Cross-trial comparisons suggest it has deeper and more durable responses than Abecma (KarMMa trial: 73% ORR, approximately 36% CR), similar efficacy to Carvykti (CARTITUDE-1: 98% ORR, 83% CR), and a more favourable safety profile than both. If the Phase III trials confirm these findings and the product secures regulatory approval, anito-cel could displace Abecma in market share and emerge as a preferred option over Carvykti in older or frailer patients. Physicians may also value its potentially more scaleable manufacturing process and faster turnaround, especially when manufacturing slots for Carvykti and Abecma are limited.
Arcellx has partnered Kite Pharma (a Gilead company), leveraging Kite’s proven CAR-T commercial infrastructure, as demonstrated by the successful launch of Yescarta (axicabtagene ciloleucel) for lymphoma.
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