Iaso Bio Announces 3-Year Follow-Up Data of Fucaso® (Eque-cel) in Relapsed/Refractory Multiple Myeloma, Demonstrating Deep and Durable Responses with Manageable Long-Term Safety

Sep 19, 2025 09:44 CST Updated 09:44

IASO Biotechnology

Cancer Treatment New Drug Developer

On September 19, 2025, IASO Bio announced today that its self-developed fully human BCMA-targeted CAR-T cell therapy product, Foksoo®(Ide-cel Injection, Eque-cel)The 36-month long-term follow-up data of the FUMANBA-1 study for the treatment of relapsed/refractory multiple myeloma (R/R MM) was officially released during the annual meeting of the International Myeloma Society (IMS).Research ResultsFurther confirmed Fokasol®Capable of delivering profound and durable efficacy for R/R MM patients (including those with high-risk features) while maintaining controllable long-term safety, significantly enhancing patients' long-term quality of life.。

驯鹿生物重磅发布CAR-T产品福可苏®治疗多发性骨髓瘤3年随访数据，实现多项数据突破 | 锋投动态

Figure 1：Product Fucos®

This research result is from the Blood Disease Hospital of the Chinese Academy of Medical Sciences(Institute of Hematology, Chinese Academy of Medical Sciences)Professor Qiu Lugui Delivered an Oral Report at the IMS Annual Meeting(Abstract ID: 2142568). This study result is the updated data from the FUMANBA-1 study, a Phase 1b/2 clinical trial conducted across 14 centers in China, aimed at evaluating Fokusu.®Safety and efficacy in the treatment of R/R MM. The study enrolled R/R MM patients who had previously received at least three lines of therapy and had disease progression, including those with extramedullary lesions.（EMD）Or patients who have previously received BCMA-targeted CAR-T therapy.

Figure 2: Professor Qiu Lugui delivering an oral presentation at the IMS Annual Meeting on the afternoon of September 18 local time.

According to the study data based on enrollment, as of December 31, 2024, a total of 109 patients have received Fokosu.®Treatment, with a median of 4 prior treatment lines. 12.8% were accompanied by EMD, and 11% had previously received BCMA CAR-T therapy. After undergoing lymphodepletion preconditioning with cyclophosphamide and fludarabine over three consecutive days, patients received a single infusion of CAR-T cells (1×10⁶ cells/kg).

Among 107 evaluable patients, the overall response rate (ORR) was 96.3%, including complete response（CR）The stringent complete response (sCR) rate was 83.2%. In CAR-T naive patients, the overall response rate (ORR) and CR/sCR rates were 98.9% and 88.4%, respectively. The median progression-free survival (PFS) for the 109 patients treated with Eque-cel was 30.5 months, and the median PFS in CAR-T naive patients extended to 35.9 months. The median overall survival (OS) has not yet been reached. Among evaluable patients, 95.3% (102/107) achieved minimal residual disease (MRD) negativity, including all patients who had achieved CR or sCR, with a median duration of MRD negativity of 36.5 months. Cytokine release syndrome (CRS) occurred in 93.6% (102/109) of patients, with only one case being grade ≥3; two patients reported immune effector cell-associated neurotoxicity syndrome (ICANS, grade 1-2); no late-onset neurotoxicity or secondary malignancies were observed.

The median 36-month follow-up data from the FUMANBA-1 study showed that Fokusu®Demonstrates deep and durable efficacy in patients with relapsed/refractory multiple myeloma (R/R MM), including those with high-risk features, and can achieve sustained minimal residual disease (MRD)-negative status. Long-term safety is manageable, with no new safety signals identified.