#China #Shanghai #CAR-T therapy #Multiple Myeloma #IASO Bio

Exciting Advances in CAR-T Therapy for Multiple Myeloma at ASH 2025

In an impactful presentation at the 2025 American Society of Hematology (ASH) Annual Meeting, IASO Biotechnology (IASO Bio) unveiled updated clinical data for its groundbreaking CAR-T therapy, Equecabtagene Autoleucel (Eque-cel), designed for high-risk patients newly diagnosed with multiple myeloma. As an innovator in the biopharmaceutical sector, IASO Bio continues to push the boundaries of treatment for this challenging disease, showcasing significant results from their pivotal study.

Background on CAR-T Therapy

CAR-T (Chimeric Antigen Receptor T-cell) therapy represents a transformative approach in cancer treatment, particularly for hematologic malignancies. This innovative therapy harnesses a patient’s own immune cells, enhancing their ability to identify and eliminate cancer cells. IASO Bio’s Eque-cel is a fully human BCMA-targeted CAR-T cell therapy specifically engineered for patients who are ineligible for transplant due to its efficacious approach to battling multiple myeloma.

Study Highlights from ASH 2025

During the oral presentation, key insights into the clinical study were shared, primarily focusing on its safety and efficacy. The presentation highlighted several critical outcomes:

• - Patient Demographics: Sixteen patients who received Eque-cel infusion were included in the analysis, all of whom exhibited at least one high-risk cytogenetic abnormality. This included various complex cases, with some patients presenting double-hit and triple-hit cytogenetics.
• - Progression-Free Survival (PFS): With a median follow-up period of 27.04 months, intriguing results emerged regarding PFS rates. The study recorded PFS rates of 87.5% at 12 months, 80.2% at 18 months, and 74.5% at 24 months, indicating Eque-cel’s potential for sustaining remission in this hard-to-treat population.
• - Minimal Residual Disease (MRD) Status: Achieving MRD negativity is crucial in evaluating the effectiveness of multiple myeloma treatments. Impressively, all participants reached MRD negativity within one month post-infusion, with 80% retaining that status beyond the 24-month mark.
• - Response Rate: The study demonstrated an objective response rate (ORR) of 100%, with an astounding 93.8% of patients attaining a stringent complete response (sCR).

Safety Profile

Safety remains a primary concern in novel therapies, and the data presented by IASO Bio reiterated the manageable safety profile of Eque-cel. While cytokine release syndrome (CRS) was observed in 68.8% of patients—primarily graded as 1-2—it was noteworthy that no neurotoxic effects or immune effector cell-associated neurotoxicity syndrome (ICANS) were recorded. The median time to CRS onset was 7 days with an average duration of 3 days, highlighting a favorable health trajectory for patients undergoing treatment.

Expert Opinions

Prominent experts contributed their insights regarding these findings. Professor Lijuan Chen remarked on the encouraging data, particularly the significant sCR rate of 93.8% combined with meaningful PFS results. The professor stated, “Eque-cel's capacity to maintain disease control, especially in high-risk populations, positions it as a promising first-line treatment option following induction chemotherapy.”

Dr. Jie Chen, IASO Bio’s Chief Medical Officer, expressed optimism regarding the therapy, affirming that these latest results reveal the potential of Eque-cel to extend survival and improve the quality of life for patients battling high-risk NDMM, while ensuring their safety during treatment.

Looking Ahead: Future of Eque-cel

As the need for innovative treatment solutions grows alongside the rising incidence of multiple myeloma—which surged from 164,300 cases globally in 2019 to a projected 273,600 by 2040—IASO Bio is poised to play a critical role in addressing this healthcare challenge. The company plans to continue monitoring patients in the FUMANBA-2 study closely, implementing long-term follow-up to confirm the sustainability of these results while aiming to make Eque-cel available to those in need.

In conclusion, IASO Bio’s updated data regarding the Eque-cel CAR-T therapy shines a hopeful light on future treatments, offering patients new avenues in the fight against multiple myeloma. As advancements in this field continue, the potential for better outcomes for patients is becoming increasingly attainable.