IASO Biotherapeutics, a biopharmaceutical company based in Shanghai and Nanjing specializing in the development of advanced cell therapies, recently revealed findings at the 66th American Society of Hematology (ASH) Annual Meeting in San Diego. The presentation focused on the impact of CAR T-cell persistence in patients with
relapsed or refractory multiple myeloma (R/RMM) treated with
Equecabtagene Autoleucel (Eque-cel). This research underscores the critical importance of sustained CAR T-cell persistence for effective disease management, indicating that baseline soluble B-cell maturation antigen (sBCMA) levels do not hinder the treatment's efficacy.
The findings from the Phase 2 FUMANMA-1 study highlight how the efficacy-to-target ratio is a significant factor determining patient outcomes. This ratio, which may serve as a future biomarker for treatment strategies, is crucial for achieving prolonged disease control in
multiple myeloma cases. The study involved 107 patients across 14 centers, with a median follow-up period of 24.67 months. Results demonstrated that patients with longer CAR T-cell persistence exhibited better clinical outcomes, such as lower risks of disease progression.
During the data analysis, researchers discovered that the efficacy-to-target ratio correlated strongly with progression-free survival (PFS) and time to progression (TTP). Patients with higher ratios showed better survival outcomes, with hazard ratios indicating a significant reduction in the risk of disease advancement. This highlights the importance of maintaining high CAR T-cell persistence for improving patient prognosis.
The study explored various baseline characteristics, such as ECOG scores, disease stages, and previous treatments. Among these, only prior autologous stem cell transplantation (ASCT) and the presence of anti-drug antibodies (ADA) post-infusion significantly related to Eque-cel persistence. The analysis also noted that only a small subset of patients experienced prolonged neutrophil recovery, suggesting that Eque-cel does not increase hematological toxicity, thus affirming its safety.
IASO Biotherapeutics' Chief Medical Officer, Dr. Jie Chen, emphasized that these findings support Eque-cel's ability to provide deep and lasting remission in R/RMM patients. The results demonstrated that Eque-cel's design, intentionally developed to be independent of sBCMA levels, offers substantial benefits in terms of durability and depth of remission. The company is now advancing a Phase 3 clinical trial to further evaluate Eque-cel as a treatment option for second- and third-line multiple myeloma.
The FUMANBA-1 study is a comprehensive clinical trial conducted across 14 centers in China. It aims to assess the safety and efficacy of Equecabtagene Autoleucel in patients who have undergone at least three prior therapy lines. The trial includes patients with prior
BCMA CAR-T treatment and those with disease progression after previous therapies.
IASO Biotherapeutics continues to focus on pioneering innovative treatments for oncology and autoimmune diseases. With a diverse product pipeline, including the fully human BCMA CAR-T injection Equecabtagene Autoleucel,
IASO Bio is committed to delivering transformative therapies to meet unmet medical needs worldwide. The company's strategic approach integrates high-quality manufacturing and clinical capabilities, aiming to provide accessible and curative treatments for patients globally.
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