On September 18, 2025 IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of innovative cell therapies, reported that the 36-month long-term follow-up data from the FUMANBA-1 study of its independently developed fully human anti-BCMA CAR-T cell therapy Fucaso (Equecabtagene Autoleucel, Eque-cel), for the treatment of relapsed/refractory multiple myeloma (R/R MM), were presented at the 2025 International Myeloma Society (IMS) Annual Meeting (Press release, IASO Biotherapeutics, SEP 18, 2025, View Source;iaso-bio-highlights-three-year-follow-up-data-of-car-t-cell-therapy-fucaso-for-multiple-myeloma-treatment-302561198.html [SID1234656080]). The results further demonstrate that Fucaso delivers deep and durable efficacy in patients with relapsed/refractory multiple myeloma (R/R MM), including those with high-risk features, along with a manageable long-term safety profile that significantly enhances overall survival quality.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The results of this study were presented by Professor Lugui Qiu from Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences in an oral presentation at the IMS Annual Meeting (Abstract Number: 2142568). This presentation is based on findings from FUMANBA-1, a phase 1b/2 study evaluating the safety and efficacy of Fucaso, which was conducted at 14 sites in China. R/R MM patients who had received at least three prior lines of therapy and with progressive disease after the last line of therapy were enrolled. And patients with extramedullary disease (EMD) or prior exposure to anti-BCMA CAR-T therapy were included.
As of December 31, 2024, a total of 109 patients with R/R MM had received Fucaso, 12.8% had EMD and 11% had received prior BCMA CAR-T therapy. Following lymphodepletion with cyclophosphamide and fludarabine for three consecutive days, a single infusion of CAR-T cells (1×10⁶ cells/kg) was administered.
Deep and durable efficacy
Among 107 evaluable patients, the overall response rate (ORR) was 96.3%, including a complete or stringent complete response (CR/sCR) in 83.2%. In CAR-T–naïve patients, ORR and CR/sCR rates were 98.9% and 88.4%, respectively. Among 109 patients who received Eque-cel, the median progression-free survival (PFS) was 30.5 months, extending to 35.9 months in CAR-T–naïve patients. Median overall survival (OS) was not reached. Minimal residual disease (MRD) negativity was achieved in 95.3% (102/107) of evaluable patients, including all patients who achieved CR or sCR, the median duration of MRD negativity was 36.5 months.
Manageable long-term safety profile
CRS occurred in 93.6% of patients, with only one case≥grade 3;
ICANS was reported in two patients (grade 1–2);
No late-onset neurotoxicity or secondary malignancies were observed.
Conclusion: At a median follow-up of 36.0 months, Fucaso therapy demonstrated deep, durable responses and sustained MRD negativity in heavily pretreated R/R MM patients, including those with high-risk features. The long-term safety profile remained manageable, with no new safety signals identified.
The principal investigators of this study, Professor Lugui Qiu, from Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, and Professor Chunrui Li, from Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, remarked: "We are delighted to present the three-year follow-up data from the FUMANBA-1 study of Eque-cel injection at this year’s IMS Annual Meeting, and the results are highly encouraging. Due to its moderate antigen affinity, Eque-cel enables rapid binding and dissociation between CAR-T cells and tumor cells, contributing to a rapid onset of action and potent tumor clearance, thereby leading to deep responses in patients with relapsed or refractory multiple myeloma (R/R MM). Furthermore, as a human-derived CAR-T product, it exhibits low immunogenicity. While maintaining a low exhaustion phenotype, it achieves prolonged persistence, resulting in sustained antitumor activity and extended patient survival. It is particularly noteworthy that Eque-cel achieved a median progression-free survival (mPFS) of 35.9 months in CAR-T–naïve patients. These results indicate that the therapy can provide a longer treatment-free interval, significantly improve patients’ quality of life[1,3]."
Ms. Jinhua Zhang, Founder, Chairwoman, and CEO of IASO Biotherapeutics, remarked: "We are greatly encouraged to see that the three-year follow-up data from the FUMANBA-1 study of Fucaso has once again confirmed its outstanding long-term efficacy and reliable safety profile. Notably, the complete response/stringent complete response rate among patients receiving BCMA CAR-T therapy for the first time has increased to 88.4%. Delivering sustained clinical benefits to patients with relapsed or refractory multiple myeloma remains our greatest motivation. The achievement of this important milestone is made possible through the collective efforts and unwavering dedication of both the investigator team and the IASO team. Building on the remarkable efficacy and safety profile of Fucaso, we are vigorously advancing the FUMANBA-3 clinical study for its second- and third-line treatments, while accelerating global registration and market access efforts to actively expand its presence in international markets. We look forward to making this high-quality CAR-T cell therapy accessible to a broader patient population worldwide."
About Equecabtagene Autoleucel (Fucaso)
Equecabtagene Autoleucel (Fucaso) is an innovative fully human anti-BCMA CAR-T cell therapy which uses lentivirus as a gene vector to transfect autologous T cells. The CAR contains a fully human scFv, CD8a hinge and transmembrane domain, and 4-1BB co-stimulatory molecule and CD3ζactivation domains. Based on rigorous molecular structure screening and comprehensive in vitro and in vivo functional evaluations, Fucaso demonstrates rapid and potent efficacy, accompanied by exceptional long-term persistence in vivo, enabling patients to achieve deep and durable remission, providing continuous protection and care for patients with multiple myeloma.
About Multiple Myeloma (MM)
Multiple myeloma (MM) is the second most common hematological malignancy globally. According to Globocan data, the global incidence of multiple myeloma in 2022 was 1.8 per 100,000 people, with a 5-year prevalence of 6.8 per 100,000. Despite progress in current anti-myeloma treatments, MM remains largely incurable with multiple relapses and tendency to develop refractoriness to several drug classes, presenting a major therapeutic challenge. Thus, there is an unmet need for new treatment options beyond these current anti-myeloma therapies for the treatment of relapsed or refractory MM, capable of achieving deep and durable responses.