- Arcellx (ACLX, Financial) reports positive Phase 2 iMMagine-1 study results for anitocabtagene autoleucel in relapsed/refractory multiple myeloma.
- 97% Overall Response Rate (ORR) and 68% Complete Response (CR) rate achieved.
- No significant neurotoxicities or treatment-related fatalities reported.
Arcellx, Inc. (NASDAQ: ACLX), a biotechnology firm focused on developing innovative cell therapies, has unveiled promising new data from its pivotal Phase 2 iMMagine-1 study. The study investigates anitocabtagene autoleucel (anito-cel), targeting patients with relapsed or refractory multiple myeloma (RRMM).
The data, as of the May 1, 2025 cutoff, includes 117 patients with a median follow-up of 12.6 months. Results showed a remarkable 97% overall response rate (114/117) with a complete response/stringent complete response rate of 68% (79/117). Additionally, a very good partial response or higher rate was observed in 85% of patients (100/117), according to the International Myeloma Working Group criteria as assessed by investigators.
Importantly, no delayed neurotoxicities, such as Parkinsonism, cranial nerve palsies, Guillain-Barré syndrome, or immune-mediated enterocolitis, have been observed with anito-cel to date. Six-month progression-free survival (PFS) and overall survival (OS) rates stand at 91.9% and 96.6%, respectively, with the 12-month rates at 78.8% and 95.2%. Notably, no treatment-related deaths or Grade ≥3 cytokine release syndrome (CRS) or ICANS events have occurred since the previous data presentation in December 2024.
Arcellx and its partner, Kite, a Gilead Company, will present these findings at the upcoming European Hematology Association (EHA) Congress on June 14, 2025, in Milan. Anito-cel is part of a strategic collaboration between Arcellx and Kite, aiming to address unmet medical needs in CAR-T therapies for RRMM patients. The company is planning for a 2026 commercial launch of anito-cel.
For more detailed information about the clinical results and future plans, Arcellx invites interested parties to join a live webcast event during EHA2025 featuring an expert panel discussion.
