Phase 1 Study of Anito-cel, a d-Domain BCMA CAR T Cell for Refractory or Recurrent Myeloma
These are very compelling phase 1 numbers in a heavily pretreated, all triple-class–refractory population. All 38 patients responded, 79% had a complete response, median progression-free survival (PFS) was 30 mos, and 3-year overall survival (OS) was 65%. The safety profile is the real headline: at the recommended dose there was no grade 3 or higher CRS, only one grade 3 immune effector cell–associated neurotoxicity syndrome (ICANS), and none of the delayed parkinsonism, cranial-nerve palsies, or colitis we’ve learned to watch for with cilta-cel. That said, it’s a small single-arm study, and the “cleaner binder” comparison to cilta-cel is in vitro and hypothesis-generating, so the iMMagine phase 2/3 data will tell us whether this truly earns a spot ahead of cilta-cel.