Arcellx: anito-cel achieves 96% ORR, 74% CR/sCR in pivotal RRMM study

Arcellx, Inc.

96% ORR (112/117) and 74% CR/sCR (86/117); 95% MRD negativity (91/96) at 10^-5 sensitivity.
12-month PFS 82.1%, OS 94.0%; 24-month PFS 61.7%, OS 83.0% in 4L+ triple/penta-refractory patients.
No delayed neurotoxicities (Parkinsonism, cranial nerve palsies, Guillain-Barré) observed; all patients dosed >12 months.
Company reiterates planned 2026 commercial launch; building commercial and medical affairs organization.
Data presented at ASH; BLA submission underway with Oct 2025 data cutoff.

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