Arcellx Inc. (NASDAQ:ACLX) shared new data on Saturday from its pivotal Phase 2 iMMagine-1 study of anitocabtagene autoleucel (anito-cel) for relapsed or refractory multiple myeloma (RRMM).
The data was presented at the 2025 American Society of Hematology (ASH) Annual Meeting and Exposition.
Anito-cel is partnered with Kite Pharma, a Gilead Sciences Inc. (NASDAQ:GILD) Company.
October 7, 2025, is the data cutoff date for this presentation and the BLA submission.
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Data
These data are for all 117 patients with a median follow-up of 15.9 months. All patients received a single infusion of anito-cel (target dose of 115×106 CAR+ viable T cells).
Preliminary results from the Phase 2 iMMagine-1 study continue to demonstrate deep and durable responses with a predictable and manageable safety profile in a fourth-line or higher RRMM population.
Overall response rate (ORR) was 96% (112/117) with a complete response/stringent complete response (CR/sCR) rate of 74% (86/117) and a very good partial response or higher (≥VGPR) rate of 88% (103/117).
Of those evaluable for minimal residual disease (MRD) testing at the time of this data cut, 95% (91/96) achieved overall MRD negativity. Of the MRD evaluable group with sufficient follow-up, 83% (54/65) sustained MRD negativity for >6 months, at a minimum of 10-5 sensitivity.
Six-month progression-free survival (PFS) and overall survival (OS) rates were 93.1% and 95.7%, respectively
- 12-month PFS and OS rates were 82.1% and 94.0%.
- 18-month PFS and OS rates were 67.4% and 88.0%.
- 24-month PFS and OS rates were 61.7% and 83.0%.
Median PFS and median OS have not been reached.
To date, no delayed or non-ICANS neurotoxicities, including no Parkinsonism, no cranial nerve palsies, no Guillain-Barré syndrome, and no immune effector cell-associated enterocolitis have been observed with anito-cel with all patients dosed more than 12 months ago.
The company reiterated its anticipated commercial launch of anito-cel in 2026.
Analyst View
William Blair wrote, “We believe the data reinforce anito-cel's best-in-class profile, with deeper responses and durable benefit emerging over time.”
“We think anito-cel's efficacy/safety profile could drive earlier-line adoption and outpatient use..,” analyst Sami Corwin added.
Needham reiterates Arcellx with a Buy rating and maintains $105 price target.
ACLX Price Action: Arcellx shares were up 10.12% at $76.59 at the time of publication on Monday, according to Benzinga Pro data.
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