Arcellx, Inc. (NASDAQ: ACLX) has just released new positive data from its pivotal phase 2 immagine-1 study of Anitocabtagene Autoleucel (anito-cel) in patients with relapsed or refractory multiple myeloma (RRMM). The data, gathered from a May 1, 2025, cutoff date, includes all 117 patients with a median follow-up of 12.6 months and a minimum follow-up of four months after treatment with anito-cel.
Key findings from the study reveal that the overall response rate (ORR) was 97% (114/117) with a complete response/stringent complete response (CR/SCR) rate of 68% (79/117). Additionally, a very good partial response or higher (≥VGPR) rate of 85% (100/117) was achieved, as per the International Myeloma Working Group (IMWG) criteria as investigator-assessed. Notably, of those evaluable for minimal residual disease (MRD) testing, 93.3% (70/75) achieved MRD negativity at a minimum of 10-5 sensitivity.
The six-month progression-free survival (PFS) and overall survival (OS) rates were reported at 91.9% and 96.6%, respectively. Furthermore, the 12-month PFS and OS rates were noted at 78.8% and 95.2%, respectively. Median PFS and median OS have not been reached.
In terms of safety, no delayed or non-immune effector cell-associated neurotoxicity syndrome (ICANS) neurotoxicities, including no parkinsonism, no cranial nerve palsies, and no guillain-barré syndrome, and no immune-mediated enterocolitis have been observed with anito-cel. Importantly, no additional treatment* or therapy-related deaths or grade ≥3 cytokine release syndrome (CRS) or ICANS events have occurred since the previous data presentation in December 2024.
Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer, emphasized the potential of anito-cel to address the unmet medical need for CAR-T therapies that are efficacious, safe, and accessible for multiple myeloma patients and their physicians. The company is actively working on commercial launch plans for anito-cel in 2026 in partnership with Kite, a Gilead company.
Anito-cel, previously known as DDBCMA, is the first BCMA-directed CAR-T cell therapy to be investigated in multiple myeloma. It utilizes Arcellx’s novel and compact binder, the D-domain, which enables high CAR expression without tonic signaling and is designed to quickly release from the BCMA target. Anito-cel has been granted fast track, orphan drug, and regenerative medicine advanced therapy designations by the U.S. Food and Drug Administration.
Today the company's shares have moved -2.1% to a price of $58.25. For the full picture, make sure to review Arcellx's 8-K report.
