IASO Bio Presents Three-Year Follow-Up Data on CAR-T Cell Therapy for Multiple Myeloma

What's Happening?

IASO Biotherapeutics has released three-year follow-up data from its FUMANBA-1 study on the CAR-T cell therapy Fucaso, aimed at treating relapsed/refractory multiple myeloma (R/R MM). The study, presented at the 2025 International Myeloma Society Annual Meeting, highlights the therapy's deep and durable efficacy, particularly in patients with high-risk features. Conducted at 14 sites in China, the study involved 109 patients who had received at least three prior lines of therapy. The results showed a 96.3% overall response rate, with a complete or stringent complete response in 83.2% of patients. The therapy demonstrated a median progression-free survival of 30.5 months, extending to 35.9 months in CAR-T-naïve patients. The safety profile was manageable, with no new safety signals identified.

Why It's Important?

The findings from IASO Bio's study are significant as they offer promising advancements in the treatment of multiple myeloma, a condition that remains largely incurable despite existing therapies. The high response rates and extended progression-free survival suggest that Fucaso could provide a longer treatment-free interval, improving patients' quality of life. This development is crucial for the biopharmaceutical industry, as it addresses the unmet need for effective treatments for relapsed or refractory MM. The therapy's success could lead to broader adoption and potentially influence treatment protocols globally, benefiting patients who have exhausted other options.

What's Next?

IASO Bio plans to advance the FUMANBA-3 clinical study for second- and third-line treatments and accelerate global registration and market access efforts. The company aims to expand the availability of Fucaso to a broader patient population worldwide. Additionally, IASO Bio is exploring further applications of its CAR-T cell therapy in autoimmune diseases, with ongoing Phase III clinical trials and Investigational New Drug approvals in both China and the U.S. The company is also advancing other products in its pipeline, including dual-target therapies for lymphoma and treatments targeting GPRC5D for R/R MM.

Beyond the Headlines

The development of Fucaso highlights the potential of CAR-T cell therapies in transforming cancer treatment. As a fully human-derived product, Fucaso exhibits low immunogenicity and prolonged persistence, which are critical factors in achieving sustained antitumor activity. This innovation underscores the importance of continued research and collaboration in the biopharmaceutical sector to address complex medical challenges. The therapy's success may pave the way for new approaches in treating other hematological malignancies and autoimmune diseases.