Enrollment Begins for Phase III iMMagine-3 Trial on Anito-Cel in Myeloma

The iMMagine-3 randomized trial has begun enrollment of patients with relapsed or refractory multiple myeloma. The study will compare the safety and efficacy of anitocabtagene autoleucel (anito-cel) with standard of care.

Tom Martin, MD, of the University of California, San Francisco, described the study’s protocol at the Society of Hematologic Oncology 2024 Annual Meeting in Houston, Texas.

Dr. Martin noted that, in a previous phase I trial, anito-cel achieved an overall response rate of 100%, including a complete response (CR) or stringent CR rate of 76% in 38 patients with relapsed or refractory multiple myeloma after three or more prior lines of therapy. Over a median follow-up of 26.5 months, median progression-free survival (PFS) was not reached and the estimated 24-month PFS rate was 56%.

Among 32 patients who received 100 × 10⁶ chimeric antigen receptor (CAR) T cells, none had grade 3 or higher cytokine release syndrome or delayed neurotoxicities, but one had grade 3 immune effector cell–associated neurotoxicity syndrome.

The iMMagine-3 trial will enroll about 450 patients to either anito-cel or standard of care at approximately 130 study sites across the globe. Key eligibility criteria include an Eastern Cooperative Oncology Group score of 0 or 1, disease progression within one year of last dose of the last regimen, and measurable disease per 2016 International Myeloma Working Group criteria.

Key exclusion criteria include prior B-cell maturation antigen–targeted therapy, prior autologous stem cell transplantation (SCT) in the 12 weeks prior to randomization, prior allogeneic SCT, and active or prior central nervous system or meningeal involvement.

The primary endpoint of iMMagine-3 is PFS with anito-cel versus standard of care as evaluated by an independent review committee. Key secondary endpoints include CR rate, overall measurable residual disease negativity, overall survival, and safety.

Reference

Martin T, Raje NS, Miguel JS, et al. iMMagine-3: a phase 3, randomized study to compare the efficacy and safety of anitocabtagene autoleucel (anito-cel) with standard of care in patients with relapsed/refractory multiple myeloma (RRMM). Abstract #MM-382. Presented at the Society of Hematologic Oncology Annual Meeting; September 4-7, 2024; Houston, Texas.