Promising phase 1 results for novel CAR T-cell therapy in MM

Anitocabtagene autoleucel (anito-cel) yielded excellent efficacy results in a heavily pre-treated population of participants with relapsed or refractory multiple myeloma (RRMM) in a phase 1 study. Phase 2 and 3 studies are initiated to further investigate this novel CAR T-cell therapy in MM.

The autologous B-cell maturation antigen (BCMA)-directed CAR T-cell therapy anito-cel was tested at 2 dose levels in a phase 1 trial among participants with RRMM who had received at least 3 prior lines of therapy. The lower dose level was administered to 32 participants, and 6 received the higher dose. Dr Binod Dhakal (Medical College of Wisconsin, WI, USA) shared findings concerning safety and efficacy [1].

The overall response rate was 100%, with a stringent complete remission (sCR)/CR rate of 76%. This result was consistent among participants with extramedullary disease (n=13) and those with high-risk cytogenetics (n=11). Dr Dhakal added that the median progression-free survival was not reached after a median follow-up of 26.5 months. The corresponding 24-month progression-free survival rate was 56%. Furthermore, 25 out of 28 evaluable participants were measurable residual disease negative (10^-5). “Remarkably, these findings are consistent in participants with extramedullary disease, a feature associated with notoriously poor prognosis,” stressed Dr Dhakal.

The toxicity profile was more favourable in the lower dose group, whereas the efficacy of the lower dose appeared to be similar to the higher dose. “We did not observe any delayed neurotoxicity, Guillain-Barre syndrome, cranial nerve palsy, or Parkinsonian-like syndrome,” highlighted Dr Dhakal. Also, there were no grade 3 cytokine release syndrome cases in the low-dose group and only 1 case of grade 3 immune effector cell-associated neurotoxicity syndrome.

Altogether, anito-cel delivered encouraging results in a heavily pre-treated population of participants with RRMM in a phase 1 trial, supporting further assessment of this novel CAR T-cell therapy in RRMM.

1. Frigault M, et al. Phase 1 study of CAR-T-ddBCMA for the treatment of patients with relapsed and/or refractory multiple myeloma: results from a least 1-year follow-up in all patients. S207, EHA congress 2024, 13–16 June, Madrid, Spain.

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Posted on 12 August 2024