Arcellx Reports Positive Phase 2 Results for Anito-cel in Multiple Myeloma Ahead of Planned 2026 Launch

Reuters12-07

Arcellx Reports Positive Phase 2 Results for Anito-cel in Multiple Myeloma Ahead of Planned 2026 Launch

Arcellx Inc. has announced new positive data from its pivotal Phase 2 iMMagine-1 study evaluating anitocabtagene autoleucel (anito-cel) in patients with relapsed or refractory multiple myeloma. The results showed a 96% overall response rate and a 74% complete or stringent complete response rate at a median follow-up of 15.9 months. Minimal residual disease (MRD) negativity was observed in 95% of patients, with 83% maintaining MRD negativity for over six months at a sensitivity level of 10^-5. Progression-free survival $(PFS)$ and overall survival $(OS)$ rates were reported at 82.1% and 94.0% at 12 months, 67.4% and 88.0% at 18 months, and 61.7% and 83.0% at 24 months, respectively. No delayed or non-ICANS neurotoxicities have been observed. These data will be presented during an oral session at the American Society of Hematology $(ASH)$ Annual Meeting on December 6, 2025. Arcellx reiterated its plans for a commercial launch of anito-cel in 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Arcellx Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251206931756) on December 06, 2025, and is solely responsible for the information contained therein.

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The results showed a 96% overall response rate and a 74% complete or stringent complete response rate at a median follow-up of 15.9 months. Minimal residual disease  negativity was observed in 95% of patients, with 83% maintaining MRD negativity for over six months at a sensitivity level of 10^-5. Progression-free survival  and overall survival  rates were reported at 82.1% and 94.0% at 12 months, 67.4% and 88.0% at 18 months, and 61.7% and 83.0% at 24 months, respectively. No delayed or non-ICANS neurotoxicities have been observed. These data will be presented during an oral session at the American Society of Hematology  Annual Meeting on December 6, 2025. 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