Cell therapy anito-cel extends treatment-resistant RRMM survival
Nearly all those who took part in iMMagine-1 study still alive after a year
Nearly all the people with relapsed or refractory multiple myeloma (RRMM) who took part in a Phase 2 clinical trial responded to the cell therapy anitocabtagene autoleucel, or anito-cel, and are still alive a year after treatment.
The findings will be reported in the oral presentation “Phase 2 Registrational Study of Anitocabtagene Autoleucel for Relapsed and/or Refractory Multiple Myeloma (RRMM): Updated Results from iMMagine-1,” at the European Hematology Association (EHA) 2025 Congress in Milan on June 14.
“These clinical data from our registrational study continue to support our belief that anito-cel has the potential to address the needs of myeloma patients and the physicians who serve them,” Rami Elghandour, chairman and CEO of Arcellx, which is developing anito-cel with Kite Pharma, said in a company press release.
Anito-cel is a CAR T-cell therapy that involves collecting and modifying a patient’s immune T-cells with a protein called a chimeric antigen receptor (CAR), which targets BCMA, a protein produced by most myeloma cells. The modified cells are then infused back into the patient to attack and kill cancer cells.
“We believe there remains an unmet medical need for CAR-T therapies that are efficacious, safe, and accessible,” Elghandour said. “Anito-cel has the unique potential to address these needs thanks to our differentiated technology, our incredible and entrepreneurial team, the robust clinical data generated to date, and our strong partnership with Kite.”
Positive response to anito-cel response
The study, called iMMagine-1 (NCT05396885), is evaluating anito-cel in RRMM patients whose disease has progressed despite at least three previous lines of therapy, including an immunomodulator, a proteasome inhibitor, and a CD38 inhibitor.
The new data included all 117 enrolled participants, with a median follow-up of 12.6 months and a minimum follow-up of four months. Most (86%) were refractory to three lines of therapy, while less than half (41%) received at least five prior lines of treatment. All received a single infusion of anito-cel.
Data showed an overall response rate of 97%, meaning nearly all of them had less cancer burden after treatment. Most (85%) achieved a very good partial response or higher, while about two-thirds (68%) reached a complete response or stringent complete response, meaning signs of cancer were no longer detectable.
About 93% of the evaluable patients achieved minimal residual disease, with virtually no cancer cells detectable after anito-cel. Nearly all were still alive at six months (96.6%) and one year (95.2%) after treatment. The progression-free survival, or the time alive without the disease worsening, was 91.9% at six months and 78.8% after a year.
As previously reported, most patients treated with anito-cel in iMMagine-1 experienced cytokine release syndrome, or CRS, an overactive inflammatory reaction, with most rated mild in severity. One patient died of CRS, one due to a fungal infection, and one due to hemorrhage. About 1 in 10 (9%) had immune effector cell-associated neurotoxicity syndrome, or ICANS, a neurological side effect.
Since then, no more treatment events or deaths, or serious CRS or ICANS events have occurred. Moreover, no delayed potential treatment-related adverse effects have been observed, including Parkinsonism, cranial nerve palsies, Guillain-Barré syndrome, and immune-mediated colitis, that is, intestinal inflammation.
“We look forward to sharing these data with the clinical community at EHA and are honored that the iMMagine-1 data will be presented during an oral presentation on Saturday, June 14,” Elghandour said.
Meanwhile, a Phase 3 trial dubbed iMMagine-3 (NCT06413498) was launched to assess anito-cel in up to 450 RRMM patients who’ve had one to three prior lines of therapy. Recruitment for this study is ongoing at multiple sites in the U.S., Europe, the U.K., Australia, and Japan.
“Our 2026 commercial launch plans for anito-cel with our partners at Kite are well underway and we are excited for the opportunity to advance anito-cel in support of the myeloma community,” Elghandour said.
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