#China #Shanghai #CAR-T therapy #IASO Bio #FUCASO

IASO Bio Presents Three-Year Follow-Up Results for CAR-T Cell Therapy Fucaso

Introduction

At the 2025 International Myeloma Society (IMS) Annual Meeting, IASO Biotherapeutics, a company known for its cutting-edge biopharmaceutical developments, shared significant findings regarding their CAR-T cell therapy named Fucaso (Equecabtagene Autoleucel). This fully human anti-BCMA CAR-T therapy specifically targets relapsed/refractory multiple myeloma (R/R MM) and the presentation showcased data from the FUMANBA-1 study, focusing on its three-year efficacy and safety profile.

Study Overview

The presentation was delivered by Professor Lugui Qiu, affiliated with the Institute of Hematology and Blood Diseases Hospital of the Chinese Academy of Medical Sciences, underlining the importance of the data shared. The study involved 109 patients suffering from R/R MM who had undergone at least three previous therapies and were struggling with progressive disease. The rigorous trial was conducted across 14 sites in China, integrating patients with extramedullary disease (EMD) and those previously exposed to anti-BCMA CAR-T therapies.

The FUMANBA-1 study primarily aimed to evaluate both safety and efficacy of the Fucaso therapy, especially given the high-risk characteristics among the patient demographic. Each participant received a single infusion of CAR-T cells following a lymphodepletion regimen, with the results revealing deep therapeutic responses.

Key Findings

Among the evaluable patients, an astonishing overall response rate (ORR) of 96.3% was recorded, with complete or stringent complete responses (CR/sCR) accounting for 83.2%. Even more remarkable was the differentiation reflected in CAR-T–naïve patients, who exhibited ORR and CR/sCR rates of 98.9% and 88.4%, respectively. The findings further delved into median progression-free survival (PFS), which was determined to be 30.5 months, extending to 35.9 months among patients unfamiliar with CAR-T therapies.

Long-term safety monitored throughout the clinical trial indicated manageable outcomes, with cytokine release syndrome (CRS) occurring in 93.6% of subjects—however, only one incident reached grade 3 severity. Importantly, no late-onset neurotoxicity or secondary malignancies were observed in participants.

Expert Commentary

Professor Qiu expressed excitement regarding the encouraging results, highlighting the rapid binding and dissociation of CAR-T cells and tumor cells due to Fucaso’s moderate antigen affinity. This property enhances the therapy’s effectiveness in achieving deep tumor responses while inducing lower immunogenicity due to its fully human-derived composition.

Similarly, IASO Bio's Chairwoman and CEO, Ms. Jinhua Zhang, echoed sentiments around the significant milestone achieved with the FUMANBA-1 study results, emphasizing the therapy’s potential to provide prolongation of treatment-free intervals and improved patient quality of life. She noted the escalating complete response rates among patients receiving their first BCMA CAR-T therapy, marking a crucial advancement in patient outcomes.

Future Directions

The implications of these results extend far beyond the current study. With a firm commitment to developing new treatment options for patients battling relapsed or refractory multiple myeloma, IASO Bio is also gearing up for the FUMANBA-3 clinical study for subsequent line treatments. Efforts to secure international market access remain high on their agenda, aiming to broaden the reach of Fucaso to patients in need worldwide.

With continued perseverance and innovation, IASO Bio not only aims to elevate their therapeutic offerings but also solidify their presence in the biopharmaceutical landscape.

Conclusion

In summary, the robust three-year follow-up data unveiled at the IMS Annual Meeting illustrates the viability of Fucaso as a formidable player in CAR-T therapies for multiple myeloma. The overwhelming efficacy and manageable safety profile position IASO Bio at the forefront of innovation in hematological treatments, reflecting hope and promise for patients grappling with this formidable disease.