Arcellx disclosed that its pivotal Phase 2 iMMagine‑1 study of anito‑cel achieved a 96 % overall response rate (ORR) and a 74 % complete response/stringent complete response (CR/sCR) rate in 117 relapsed/refractory multiple myeloma patients, 87 % of whom were triple‑refractory and 41 % penta‑refractory.
The data, cut off on October 7 2025, were presented at the 67th American Society of Hematology meeting on December 6 2025. The high efficacy in a heavily pre‑treated cohort underscores the potential of anito‑cel’s D‑domain binder platform to deliver durable remissions in a population with limited options.
Safety outcomes were favorable: 95 % of patients achieved minimal residual disease (MRD) negativity, 82.1 % reached 12‑month progression‑free survival (PFS), and 94.0 % achieved 12‑month overall survival (OS). No delayed neurotoxicity or non‑ICANS neurotoxicities were observed in patients dosed more than 12 months prior, a safety profile that compares favorably with the neurotoxicity rates reported for Abecma and Carvykti.
Arcellx’s management highlighted the commercial implications of the data. CEO Rami Elghandour said the results “position anito‑cel as a category leader and give us confidence to launch in 2026.” The company reported a $55.8 million net loss for Q3 2025 but holds $576 million in cash, cash equivalents, and marketable securities, providing a runway to 2028 and supporting the planned launch timeline.
The efficacy and safety profile strengthen anito‑cel’s competitive positioning. Compared with the latest data for Abecma and Carvykti, anito‑cel shows higher 12‑month PFS and OS rates and a lower incidence of neurotoxicity, suggesting a potential advantage in both clinical benefit and tolerability.
Regulatory milestones support the commercial trajectory: anito‑cel has Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations, and the company completed a pre‑BLA meeting with the FDA, reinforcing the pathway toward a 2026 launch.
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