Arcellx Announces New Positive Data for Its iMMagine-1 Study in Patients with Relapsed and/or Refractory Multiple Myeloma

Core Insights - Arcellx, Inc. announced positive data from its pivotal Phase 2 iMMagine-1 study of anitocabtagene autoleucel (anito-cel) for relapsed or refractory multiple myeloma (RRMM) [1][5] - The study demonstrated a high overall response rate (ORR) of 96% and a complete response/stringent complete response (CR/sCR) rate of 74% [3] - Anito-cel has shown a manageable safety profile with no delayed or non-ICANS neurotoxicities reported [4][5] Study Details - The data presented includes results from 117 patients with a median follow-up of 15.9 months, where 87% were triple refractory and 41% were penta refractory [2] - Patients received a median of three prior lines of therapy, with 56% having received three prior lines [2] Efficacy Metrics - The study reported a very good partial response or higher (VGPR) rate of 88% and 95% of evaluable patients achieved overall minimal residual disease (MRD) negativity [3] - Six-month progression-free survival (PFS) and overall survival (OS) rates were 93.1% and 95.7%, respectively, with 12-month PFS and OS rates at 82.1% and 94.0% [3] Safety Profile - No delayed or non-ICANS neurotoxicities, including Parkinsonism or Guillain-Barré syndrome, have been observed in patients dosed more than 12 months ago [4][5] Future Plans - The company plans for a commercial launch of anito-cel in 2026 and is building a commercial and medical affairs organization to support this [6][11] - The collaboration with Kite, a Gilead Company, aims to co-develop and co-commercialize anito-cel for multiple myeloma [11] Presentation Information - The updated results from the iMMagine-1 study will be presented at the 67th American Society of Hematology (ASH) Annual Meeting on December 6, 2025 [1][7]