At a data cut-off of May 1, 2025, 117 pts had received anito-cel under the final manufacturing process with a median follow-up of 12.6 months. Median age was 64 years (range, 38 -78) and racial distribution was 89 (76%) White, 17 (15%) Black or African American, and 11 (9%) Asian or Other. Median time from MM diagnosis was 7.2 years (range, 1.0 - 23.1), and median prior LoT was 3 (range, 3 - 8) with 51% receiving only 3 prior LoT. All pts (n=117, 100%) were refractory to their last LoT, 100 (86%) were triple-class refractory, 47 (40%) were penta-drug refractory, 18 (15%) had extramedullary disease, and 44 (38%) had high-risk cytogenetics. Ten pts (9%) received outpatient infusion of anito-cel.

Investigator-assessed ORR per IMWG criteria was 97% (114/117) with a CR/sCR rate of 68% (79/117) with a median time to first response of 1.0 month (range, 0.9 - 13.4). Of those evaluable for MRD testing (n=75), 70 (93%) achieved MRD negativity at the level of 10-5 with a median time to MRD negativity of 1.0 month (range, 0.9 – 6.4), and MRD negativity at the level of 10-6 was achieved in 78% (53/68). Using Kaplan-Meier methods, the PFS rates at 12- and 18-month milestone timepoints were 79% and 66%, respectively, with 12- and 18-month OS rates being 95% and 90%, respectively. Median PFS and OS have not been reached.

The most common grade 3/4 treatment emergent adverse events (AEs) were cytopenias: 77 pts (66%) with neutropenia, 28 (24%) with anemia, and 28 (24%) with thrombocytopenia. Grade 3/4 infections were reported in 11 pts (9%). Ninety-nine pts (85%) had CRS Gr1 or less, including 17 (15%) with no CRS, and 114 (97%) had either no CRS or CRS resolution ≤10 days of anito-cel infusion. Any grade CRS was observed in 100 pts (85%) with 82 (70%) Gr1, 17 (15%) Gr2, and 1 (1%) Gr5. Median onset was 4 days (range, 1-17) with a median duration of 2 days (range, 1-9). Any grade ICANS was observed in 9 pts (8%) with 4 (3%) Gr1, 4 (3%) Gr2, and 1 (1%) Gr3. No delayed or non-ICANS neurotoxicities including no Parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome have been observed. No IEC-associated enterocolitis and no secondary primary malignancies of T-cell origin have been reported.