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Anito-cel produced high ORR and sCR/CR rates in patients with relapsed/refractory multiple myeloma.
Anitocabtagene autoleucel (anito-cel) represents an interesting developmental CAR T-cell therapy with a unique mechanism of action that could become an additional treatment option for patients with triple-class–exposed, relapsed/refractory multiple myeloma, according to Suzanne Fanning, DO.1
“Anito-cel has a D-domain that binds to BCMA,” Fanning said when moderating an OncLive® Scientific Interchange and Workshop on advancing CAR T-cell therapy in multiple myeloma from a community perspective. “It’s a smaller construct that results in better uptake. It is fully humanized and binds to murine antibodies. There’s a hope for less immunogenicity; it’s a different construct of CAR T for BCMA than we’ve seen previously.”
Fanning is anassociate professor at the University of South Carolina School of Medicine Greenville as well as the director of the Transplant and Cellular Therapy Program and a hematologist/oncologist at Prisma Health Cancer Institute, which is also in Greenville, South Carolina.
iMMagine-1 Trial: Key Takeaways
During the workshop, the participants noted that there are presently 2 FDA-approved CAR T-cell therapies for the treatment of patients with relapsed/refractory multiple myeloma: idecabtagene vicleucel (ide-cel; Abecma) and ciltacabtagene autoleucel (cilta-cel; Carvykti).2,3 They added that beyond clinical factors such as target confirmation and the presence of comorbidities, financial and logistical considerations must be weighed when selecting a patient for CAR T-cell therapy in the real-world setting.1
Notably, since the FDA removed the Risk Evaluation and Mitigation Strategies (REMS) requirements for CAR T-cell therapy in June 2025, the therapy has become more accessible for patients because hospitals and clinics no longer need to be specifically certified to administer these treatments. Prior REMS requirements necessitated post-infusion monitoring of patients for at least 4 weeks—including at least 10 days of daily monitoring, patients remaining within the proximity of a health care facility for at least 4 weeks post-infusion, and patients avoiding driving for 8 weeks post-infusion. The updated requirements necessitate only 2 weeks of monitoring, patient proximity within a health care facility for at least 2 weeks, and patient driving avoidance for 2 weeks.
Although ide-cel and cilta-cel are effective options, there remains an unmet need for additional therapies for patients with triple-class–refractory disease, the workshop participants noted. Novel CAR T-cell approaches that are in development, such as anito-cel, could help to fill this void.
Anito-cel was examined in patients with relapsed/refractory multiple myeloma in the phase 2 iMMagine-1 trial (NCT05396885).4 The study enrolled patients who had received at least 3 prior lines of therapy, including an immunomodulatory drug, a proteasome inhibitor, and a CD38-targeted agent. Patients were also required to have measurable disease, be refractory to their last line of treatment, and have evidence of measurable disease.
The primary end point was overall response rate (ORR) per 2016 IMWG criteria. Secondary end points included complete response (CR)/stringent CR (sCR) rate per 2016 IMWG criteria and ORR in patients who were limited to 3 lines of therapy.
At a median follow-up of 12.6 months (range, 5-29), findings from iMMagine-1 presented during the 2025 EHA Congress revealed that patients who received anito-cel (n = 117) achieved an ORR of 97%, including a sCR/CR rate of 68%. Moreover, 93% of evaluable patients (n = 70/75) experienced minimal residual disease (MRD) negativity at a threshold of 10–5. The median time to first response was 1.0 month (range, 0.9-13.4), and the median time to MRD negativity was 1.0 month (range, 0.9-6.4).
The estimated 6- and 12-month progression-free survival rates were 91.9% (95% CI, 85.0%-95.7%) and 79.3% (95% CI, 68.6%-86.7%), respectively. The respective estimated overall survival rates at these time points were 96.6% (95% CI, 91.1%-98.7%) and 95.2% (95% CI, 88.7%-98.0%).
In terms of safety, the profile of anito-cel was predictable and manageable. Most patients (92%) did not experience any immune effector cell–associated neurotoxicity syndrome (ICANS). The median duration and onset of ICANS were 4 days (range, 1-12) and 7 days (range, 2-10), respectively.
Cytokine release syndrome (CRS) was largely grade 1 (70%) in severity, with 15% of patients experiencing no CRS. The median time to onset of CRS was 4 days (range, 1-17), and the median duration of CRS was 2 days (range, 1-9).
Updated data from iMMagine-1 are set to be presented in an oral session during the upcoming 2025 ASH Annual Meeting in December.5
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