IASO Biotherapeutics has unveiled compelling three-year follow-up data for its CAR-T cell therapy Fucaso (Equecabtagene Autoleucel) in treating relapsed/refractory multiple myeloma, presented at the 2025 International Myeloma Society Annual Meeting. The data, spanning a median follow-up of 36.0 months, demonstrates sustained deep responses and durable minimal residual disease negativity in heavily pretreated patients, including those with high-risk disease features.
Enhanced Response Rates in CAR-T-Naïve Patients
The FUMANBA-1 study results revealed particularly striking outcomes in patients receiving BCMA CAR-T therapy for the first time, with the complete response/stringent complete response rate reaching 88.4%. This population achieved a median progression-free survival of 35.9 months, representing a significant treatment-free interval that substantially improves patients' quality of life.
"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," explained Professor Lugui Qiu from the 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, the study's principal investigators.
Sustained Safety Profile
The long-term safety analysis showed no new safety signals emerged over the three-year observation period, with the safety profile remaining manageable throughout. As a human-derived CAR-T product, Fucaso exhibits low immunogenicity while maintaining a low exhaustion phenotype, contributing to its prolonged persistence and sustained antitumor activity.
Addressing Unmet Medical Need
Multiple myeloma represents the second most common hematological malignancy globally, with a 2022 global incidence of 1.8 per 100,000 people and a 5-year prevalence of 6.8 per 100,000, according to Globocan data. Despite therapeutic advances, the disease remains largely incurable with multiple relapses and tendency to develop drug resistance, creating significant unmet medical needs.
Global Expansion Strategy
Jinhua Zhang, Founder, Chairwoman, and CEO of IASO Biotherapeutics, emphasized the company's commitment to global accessibility: "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."
Fucaso received approval from China's National Medical Products Administration in June 2023, marking it as the world's first fully human CAR-T therapy. The treatment has also gained approval in Macau, with New Drug Applications currently under review in Hong Kong, Singapore, and Saudi Arabia. The therapy has received Orphan Drug Designation in South Korea, with registration efforts progressing in additional countries.
Innovative CAR-T Design
Equecabtagene Autoleucel utilizes lentivirus as a gene vector to transfect autologous T cells, incorporating a fully human single-chain variable fragment, CD8a hinge and transmembrane domain, and 4-1BB co-stimulatory molecule with CD3ζ activation domains. This design, based on rigorous molecular structure screening and comprehensive functional evaluations, enables rapid and potent efficacy with exceptional long-term persistence in vivo.
