Shanghai – September 26, 2026 -- IASO Biotechnology's CAR-T therapy FUCASO achieved a 95.9% objective response rate and 77.2% complete/stringent complete response rate in a real-world study of 281 heavily pretreated Chinese patients with relapsed or refractory plasma cell neoplasms, data presented at the 2026 International Myeloma Society Annual Meeting show.
Real-world cohort skews higher-risk than pivotal trial population
The multicenter study tracked patients treated since FUCASO's June 2023 launch across China. Median age was 61 years, with 18.7% aged 70 or older, and patients had received a median of four prior therapy lines, up to 12. Prior anti-CD38 exposure reached 84.0%, 27.4% were penta-exposed, and 46.9% had undergone autologous stem cell transplantation. High-risk cytogenetic abnormalities affected 82.4% of patients, 50.5% were ISS stage III, 7.8% had plasma cell leukemia, and 47.0% presented extramedullary disease.
MRD negativity reaches 94.1% among efficacy-evaluable patients
Among 267 evaluable patients, the ≥VGPR rate hit 86.9% and MRD negativity reached 94.1%. At a median follow-up of 10.97 months, median progression-free survival and overall survival had not been reached; 12-month PFS stood at 71.5% and 12-month OS at 87.8%.
High-risk subgroups show consistent benefit without added toxicity
Patients over 70 (n=35) posted a 94.3% ORR and 69.6% 12-month PFS. Those with prior anti-CD38 exposure recorded a 96.0% ORR and 68.5% 12-month PFS. Cytogenetically defined high-risk patients (94 of 177) achieved a 98.9% ORR and 65.1% 12-month PFS, with no additional increase in grade 3 or higher cytokine release syndrome or neurotoxicity across these subgroups.
Safety profile stays manageable despite heavier pretreatment burden
Any-grade CRS occurred in 88.2% of patients, with only 3.8% grade 3 or higher; any-grade immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 6.8%, and no parkinsonism was reported. Stratification by CAR-HEMATOTOX score identified a higher-risk subgroup with a lower 12-month PFS rate (60.3% versus 86.9% for low-risk patients) and elevated toxicity rates — 6.5% grade 3 or higher CRS and 9.7% ICANS — pointing to a need for tighter safety monitoring in this population.
Peking University physician says data confirm broad clinical applicability
Professor Jin Lu of Peking University People's Hospital, who presented the findings as Abstract OA-09, said the real-world cohort carried more poor-prognostic features than the registration trial population yet still produced consistent efficacy across elderly, anti-CD38-exposed, and high-risk cytogenetic subgroups, with median PFS still unreached.