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Highlights
- High Response Rates: The Phase 2 iMMagine-1 study of anito-cel in relapsed or refractory multiple myeloma (RRMM) patients showed an overall response rate (ORR) of 97%, with 62% achieving complete or stringent complete responses (CR/sCR).
- Durable Outcomes: 6-month progression-free survival (PFS) and overall survival (OS) rates were 93.3% and 96.5%, respectively, while 12-month rates were 78.5% and 96.5%.
- Safety Profile: No delayed or non-ICANS neurotoxicities were observed. Cytokine release syndrome (CRS) was mild in the majority of patients, and no treatment-related Grade ≥3 CRS or ICANS events occurred.
Arcellx, Inc. (NASDAQ:ACLX) presented promising new data from the Phase 2 iMMagine-1 study of anito-cel (anitocabtagene autoleucel), a novel immunotherapy for relapsed or refractory multiple myeloma (RRMM), at the 66th American Society of Hematology (ASH) Annual Meeting. The study enrolled patients with high-risk, heavily pre-treated RRMM, including those with triple- and penta-class refractory disease.
Study Results:
- Overall Response Rate (ORR): The ORR for anito-cel was 97%, with 62% of patients achieving a complete or stringent complete response (CR/sCR). Additionally, 81% achieved a very good partial response (VGPR) or higher.
- Minimal Residual Disease (MRD) Negativity: 93.1% of patients evaluable for MRD testing achieved MRD negativity at a minimum sensitivity of 10^-5.
- Progression-Free Survival (PFS) and Overall Survival (OS): The median PFS and OS have not yet been reached. The 6-month PFS and OS rates were 93.3% and 96.5%, respectively. The 12-month rates were 78.5% for PFS and 96.5% for OS.
- Safety Profile: Anito-cel demonstrated a predictable and manageable safety profile. Cytokine release syndrome (CRS) was observed in 86% of patients, with most cases being Grade ≤1. Only 9% of patients experienced any Grade of immune effector cell-associated neurotoxicity syndrome (ICANS), with all cases resolving without sequelae. Importantly, no delayed neurotoxicities such as Parkinsonism or Guillain-Barré syndrome were reported.
Conclusions: These data underscore the potential of anito-cel as a promising treatment for RRMM patients, particularly those with triple- and penta-refractory disease. The deep and durable responses, coupled with the manageable safety profile, highlight anito-cel's potential to become a critical treatment option for patients with limited therapeutic alternatives. The absence of serious neurotoxicities such as Parkinsonism and Guillain-Barré syndrome further strengthens the safety profile of anito-cel.
