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IASO Bio’s FUCASO shows 95.9% response in tough plasma cell neoplasm cases

IASO Bio’s FUCASO shows 95.9% response in tough plasma cell neoplasm cases GenoMethods.org © genomethods.org
IASO Bio’s FUCASO shows 95.9% response in tough plasma cell neoplasm cases © genomethods.org
FUCASO from IASO Bio hit a 95.9% response rate in heavily pretreated plasma cell neoplasm patients in China. Results show strong durability and manageable safety in real-world clinical use.

Doctors in China have been treating some of the hardest plasma cell neoplasm cases with FUCASO. The therapy delivered a 95.9% objective response rate in a real-world group, many of whom had already tried several other treatments.

The results came out at the 2026 International Myeloma Society Annual Meeting. Data from 281 patients treated since June 2023 show FUCASO can trigger deep responses and keep them going. This held true even for patients with high-risk cytogenetics, prior anti-CD38 therapy, or advanced age. Most patients had already gone through four lines of therapy. Some had tried up to twelve before FUCASO. The company says FUCASO is the world’s first fully human BCMA-targeting CAR-T cell therapy made for relapsed or refractory plasma cell neoplasms.

In the real-world cohort, 82.4% of patients had high-risk cytogenetic abnormalities, and nearly half presented with extramedullary disease, highlighting the challenging population treated.

Out of 267 patients who could be evaluated for efficacy, the numbers stand out. 95.9% had an objective response. 77.2% reached complete or stringent complete response. 94.1% became minimal residual disease negative. The median follow-up was almost eleven months. Median progression-free and overall survival have not been reached yet. At 12 months, progression-free survival was 71.5%. Overall survival was 87.8%. These results were shared in an oral session at the 2026 IMS Annual Meeting. The global myeloma field took notice.

FUCASO (equecabtagene autoleucel injection, Eque-cel) was tested in a real-world setting with many patients facing poor odds. 82.4% had high-risk cytogenetic abnormalities. 50.5% were ISS stage III. Nearly half had extramedullary disease. 18.7% were 70 or older. 84% had already received anti-CD38 therapy. IASO Bio says these results prove "deep and durable responses" and a good safety profile, even for older patients and those with high-risk cytogenetics. More details are in the KXAN clinical report.

Safety data back up FUCASO’s use in the clinic. Cytokine release syndrome (CRS) of any grade happened in 88.2% of patients. Only 3.8% had grade 3 or higher CRS. Immune effector cell-associated neurotoxicity syndrome (ICANS) was seen in 6.8%. No cases of parkinsonism were reported. When patients were grouped by CAR-HEMATOTOX score, those at high risk had more severe CRS and ICANS. Their 12-month progression-free survival was lower (60.3%) compared to low-risk patients (86.9%). This shows high-risk patients need closer safety monitoring.

A separate retrospective analysis, FUMANBA-1, was also presented by IASO Bio at the 2026 IMS as a poster, further supporting the durability and persistence of FUCASO’s CAR-T cells in vivo and their association with sustained MRD negativity and delayed disease progression.

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The real-world results match what was seen in FUCASO’s pivotal registration study. The therapy’s benefits hold up in broader, more complex patient groups. High-risk subgroups—those over 70, those previously treated with anti-CD38, and those with high-risk cytogenetics—still saw strong response rates and survival. No new safety issues came up.

Professor Jin Lu from Peking University People's Hospital presented the findings. He pointed out that the real-world group was older, had more prior treatments, and faced more aggressive disease than the registration study. Still, FUCASO kept its high response rates and deep remissions. Median progression-free survival has not been reached. That says a lot about how long these responses last.

CAR-T therapies are changing blood cancer treatment fast. As reported earlier, scientists are also working on ways to use CAR-T for other cancers. The field is moving quickly.

IASO Bio’s FUCASO real-world data set a new bar for patients with relapsed or refractory plasma cell neoplasms. This is especially true for those with few options left. Efficacy and safety stayed strong across high-risk groups. The durability of response stands out. FUCASO is now a major player in the BCMA CAR-T field. For doctors and patients dealing with late-stage myeloma, these results open new doors for disease control and remission. The standard has changed. Others will have to catch up.

Elena MacLeod Clinical biotechnology and CAR-T editor GenoMethods.org
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Elena MacLeod

Elena MacLeod is Clinical Biotechnology Editor at GenoMethods, covering CAR-T, engineered cell therapies, gene therapy, clinical trials, cancer immunology and regulatory developments. Her evidence-first reporting focuses on trial design, patient populations, safety, efficacy, response durability and the limitations that determine how early clinical results should be interpreted.