IASO Bio's CAR-T Therapy Shows 93.8% Complete Response Rate in High-Risk Multiple Myeloma Patients
核心洞察
IASO Bio (搜索) presented updated results for Equecabtagene Autoleucel (Eque-cel (搜索)), a fully human BCMA (搜索)-targeted CAR-T therapy, showing 93.8% stringent complete response rate in high-risk newly diagnosed multiple myeloma (搜索) patients.
The FUMANBA-2 phase 1 study demonstrated that all 16 patients achieved minimal residual disease negativity within one month, with 80% maintaining sustained negativity beyond 24 months.
The therapy showed a manageable safety profile with no neurotoxicity observed and all cytokine release syndrome (搜索) events limited to grade 1-2 severity.
IASO Biotechnology (搜索) presented compelling updated clinical data for its fully human BCMA (搜索)-targeted CAR-T cell therapy, Equecabtagene Autoleucel (Eque-cel (搜索)), at the 2025 American Society of Hematology Annual Meeting. The results from the FUMANBA-2 phase 1 study demonstrate exceptional efficacy in transplant-ineligible patients with high-risk newly diagnosed multiple myeloma (搜索), achieving a 93.8% stringent complete response rate with a manageable safety profile.
Study Design and Patient Population
The open-label, single-arm phase 1 study enrolled 16 patients with high-risk newly diagnosed multiple myeloma (搜索) who were ineligible for transplantation. All patients presented with at least one high-risk cytogenetic abnormality, with 11 patients having double-hit cytogenetics and 2 patients having triple-hit cytogenetics. Additionally, 2 patients had R-ISS stage III with double-hit cytogenetics, 1 patient had R-ISS stage III with triple-hit cytogenetics, and 4 patients presented with extramedullary disease.
The primary endpoints of the study were the proportion of patients achieving minimal residual disease (MRD) negativity and progression-free survival (PFS).
Efficacy Results
With a median follow-up of 27.04 months as of May 13, 2025, the study demonstrated remarkable efficacy outcomes. The objective response rate reached 100%, with 93.8% of patients achieving stringent complete response. All patients achieved MRD negativity within one month of treatment, and 80% maintained sustained MRD negativity beyond 24 months.
The progression-free survival data showed particularly encouraging results, with the median PFS not yet reached. PFS rates at 12, 18, and 24 months were 87.5%, 80.2%, and 74.5%, respectively, demonstrating durable disease control even in this high-risk patient population.
Safety Profile
Eque-cel (搜索) demonstrated a manageable safety profile in the study. Cytokine release syndrome (搜索) (CRS) occurred in 11 patients (68.8%), but all cases were grade 1-2 in severity. The median time to CRS onset was 7 days, with a median duration of 3 days. Notably, no neurotoxic effects or immune effector cell-associated neurotoxicity syndrome (搜索) (ICANS) were observed throughout the study period.
Clinical Significance
Professor Lijuan Chen from Jiangsu Province Hospital emphasized the clinical importance of these findings: "The updated data from the FUMANBA-2 study presented at the 2025 ASH Annual Meeting are encouraging. Among all enrolled high-risk patients, we observed an sCR rate of 93.8%, with 80% of patients maintaining sustained MRD negativity for over 24 months. In high-risk patient groups, including those with double-hit/triple-hit cytogenetics and R-ISS stage III with EMD, Eque-cel (搜索) continued to demonstrate durable disease control, achieving a 24-month PFS rate of 74.5%. This suggests that this therapy could be a promising and effective treatment option as first line therapy following induction chemotherapy for high-risk NDMM."
Future Development
Dr. Jie Chen, Chief Medical Officer and Senior Vice President of IASO Bio (搜索), commented on the company's plans: "We are delighted to present the promising data for Eque-cel (搜索) in the treatment of high-risk NDMM at the 2025 ASH Annual Meeting. The FUMANBA-2 study data presented confirm its deep and durable responses in this patient population, with no observed ICANS and all CRS events limited to grade 1-2. We will continue to advance the long-term follow-up of this study and look forward to bringing this innovative therapy to patients in need earlier."
Disease Context
Multiple myeloma (搜索) represents a significant global health burden, with annual incidence increasing from 164,300 cases in 2019 to 197,200 in 2024, and projected to reach 273,600 by 2040 worldwide. In China specifically, incidence rose from 28,100 in 2019 to 31,800 in 2024, with an estimated 30-40% of patients progressing to third-line therapy, highlighting the need for effective first-line treatments for high-risk patients.