iMMagine-1 phase II updated results: Anito-cel for RRMM

Updated results from iMMagine-1 (NCT05396885), a phase II registrational study of anitocabtagene autoleucel (anito-cel) for the treatment of 117 adult patients with relapsed/refractory multiple myeloma (RRMM), were presented by Krina Patel at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, December 6–9, 2025, Orlando, US. Patients were triple-class exposed, had progressed ≥3 lines of therapy (LoT), had measurable disease, and were refractory to their last LoT. The primary endpoint was overall response rate (ORR) per independent review committee (IRC).

Key data: At 15.9 months median follow-up, IRC-assessed ORR was 96%, with 74% and 88% of patients achieving a stringent complete response/complete response (sCR/CR) and very good partial response or better (≥VGPR), respectively. Responses deepened over time, with a median time to first response of 1.0 months (interquartile range [IQR], 1.0–1.9 months) and a median time to best response of 4.8 months (IQR, 2.1–9.0 months). Of evaluable patients, 95% achieved minimal residual disease (MRD)-negativity (median time, 1.0 month [0.9–6.4]); sustained ≥6 months in 83% of patients. Median progression-free survival (PFS) and overall survival (OS) were not reached, while 24-month PFS and OS rates were 61.7% (confidence interval [CI], 48.0–72.8) and 83.0% (CI, 70.7–90.5), respectively. 95% of patients had either no cytokine release syndrome (CRS) or CRS that resolved within 10 days of anito-cel infusion, and 92% of patients experienced no immune effector cell-associated neurotoxicity syndrome (ICANS). The most common Grade ≥3 treatment-emergent adverse events (TEAEs) were cytopenias. 

Key learning: Anito-cel demonstrated deep and durable efficacy in patients with triple-class exposed RRMM with ≥3 LoT, and a manageable safety profile, supporting the continued evaluation of this therapy in this patient population.