Anito-cel shows high 2-year survival rate in myeloma trial: Data
Majority of patients on experimental cell therapy remain progression free
Most people with hard-to-treat myeloma were still alive and free from disease progression two years after treatment with anito-cel (anitocabtagene autoleucel), an experimental cell therapy being developed by Arcellx and Kite Pharma,
That’s according to updated data from iMMagine-1 (NCT05396885), a Phase 2 trial testing anito-cel in people with myeloma whose disease has failed to respond or has come back after at least three prior lines of therapy, including an immunomodulator, a proteasome inhibitor, and a CD38 inhibitor.
The data from the “Phase 2 registrational study of anitocabtagene autoleucel for the treatment of patients with relapsed and/or refractory multiple myeloma: Updated results from iMMagine-1” were presented over the weekend at the annual meeting of the American Society of Hematology.
“The data from iMMagine-1 continue to reinforce our belief that anito-cel is poised to become a category leader in treating multiple myeloma patients,” Rami Elghandour, chairman and CEO of Arcellx, said in a company press release.
Cindy Perettie, executive vice president at Kite, was also optimistic about the results.
“The deep, durable responses seen with iMMagine-1, combined with a predictable and manageable safety profile and rapid and reliable manufacturing, highlight anito-cel’s potential to redefine care,” Perettie said in a separate press release.
Companies plan to make therapy commercially available in 2026
Arcellx and Kite are planning to use the findings as a basis to ask the U.S. Food and Drug Administration to approve anito-cel. If all goes as planned, the companies hope to make the therapy commercially available in 2026.
“Our plans for a 2026 commercial launch are well underway,” Elghandour said. “We are building a world-class commercial and medical affairs organization to ensure broad patient access and physician support. We remain committed to a launch of unparalleled scale and impact to meet the needs of the myeloma community and to demonstrate the true potential of cell therapy.”
The iMMagine-1 trial enrolled 117 participants, all of whom were treated with a single infusion of anito-cel. Results showed almost all (96%) of the patients responded to treatment. Specifically, nearly three-quarters (74%) of patients had a complete response and no longer showed obvious signs of cancer. Most of these patients tested negative for minimal residual disease, essentially meaning no cancer cells were detectable.
One year after anito-cel treatment, 94% of patients were still alive, and 82.1% were free of disease progression. Two years after treatment, 83% were still alive, and 61.7% had no disease progression. Median survival and progression time have not yet been reached — in other words, most of the study participants are still alive without signs of disease progression.
Anito-cel targets protein expressed by myeloma cells
According to Arcellx, the response to anito-cel is continuing to deepen over time. In other words, as more patients are followed for longer periods, a greater number are showing a response. The company stated that the cell therapy ia exhibiting a “predictable and manageable safety profile.”
These findings “are compelling and are an important advancement for patients living with multiple myeloma, said Krina Patel, MD, an investigator on the iMMagine-1 trial at the University of Texas MD Anderson Cancer Center. “I am encouraged by the depth of responses in the iMMagine-1 study. For clinicians, we rely on therapies that deliver continued meaningful efficacy, a predictable safety profile, and reliable manufacturing. Anito-cel demonstrates that it could become a significant new treatment option in our efforts to improve outcomes for patients with multiple myeloma.”
Myeloma is a form of blood cancer caused by the uncontrolled growth of certain types of immune cells in the bone marrow. Anito-cel is an autologous CAR T-cell therapy, a type of treatment that works by taking cancer-killing immune cells called T-cells from a patient and equipping them with a molecular weapon called a chimeric antigen receptor (CAR) that allows them to more effectively kill cancer. In anito-cel, the T-cells are specifically equipped with a CAR targeting BCMA, a protein expressed by myeloma cells. The modified T-cells are then infused into the patient to target and destroy the cancer cells.
“Our goal is to deliver a differentiated, one-time treatment option in 2026 that may reduce patient burden and improve access, including in outpatient and community oncology settings,” Perettie said.
Kite is now sponsoring a Phase 3 trial called iMMagine-3 (NCT06413498) to test anito-cel in people with myeloma that has failed to respond or has come back after one to three prior lines of therapy. The trial is recruiting participants at sites in the U.S., Europe, Canada, Japan, and Australia.
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