SHANGHAI and NANJING, China and SAN JOSE, Calif., June 15, 2024 /PRNewswire/ -- IASO biotechnology ("IASO Bio"), a biopharmaceutical company engaged in discovering, developing, manufacturing and marketing innovative cell therapies and antibody products, presented clinical data on the use of Equecabtagene Autoleucel (Eque-cel), the world's first approved fully human CAR-T product, for the treatment of transplant-ineligible patients with high-risk newly diagnosed multiple myeloma (NDMM) in an oral presentation at the 2024 European Hematology Association (EHA) Annual Congress.
Presentation Title: Eque-cel, A Novel Fully Human BCMA-Targeting CAR-T Therapy in Patients with High Risk Newly Diagnosed Multiple Myeloma
Presentation Type: Oral report
Session Date and Time: June 15, 2024, 16:30 - 17:45 (Central European Summer Time)
Location: Madrid, Spain
Publication Number: S206
Presenter: Professor Bing Chen, Nanjing Drum Tower Hospital
The FUMANBA-2 study is a multicenter, open-label, phase I, single-arm study initiated by researchers, with the principal investigators being Professor Lijuan Chen from Jiangsu Province Hospital and Professor Bing Chen from Nanjing Drum Tower Hospital. This study aims to assess the efficacy, safety, and pharmacokinetics/pharmacodynamics characteristics of Eque-cel for the treatment of high-risk NDMM. Subjects must complete four cycles of induction treatment before the infusion of Eque-cel. After the third induction treatment cycle, patients deemed unsuitable for autologous hematopoietic stem cell transplantation (ASCT) by the researcher will undergo peripheral blood mononuclear cell collection and subsequently receive Eque-cel treatment, with an infusion dose of 1×106 CAR-T/kg.
The primary endpoints were the proportion of minimal residual disease (MRD) negative subjects and progression-free survival (PFS), and secondary endpoints included overall response rate (ORR), duration of response (DOR), safety, and pharmacokinetics/pharmacodynamics (PK/PD).
As of January 25th, 2024, 16 subjects received Eque-cel therapy. High-risk cytogenetics were detected in all subjects, including 62.5 percent double-hit and 12.5 percent triple-hit. 25 percent subjects had extramedullary disease. 37.5 percent subjects had R-ISS stage III disease, among whom 6.3 percent with double-hit and 6.3 percent with triple-hit.
Efficacy: After the infusion of Eque-cel, the median follow-up time was 7.46 months (range: 2.8-18.1), the median PFS had not been reached, the 12-month PFS rate was 84.4% (95% CI: 49.31-96.00), all subjects achieved MRD negativity, of which 71.4% (95% CI: 25.8-92.0) maintained MRD negativity for more than 12 months; the overall response rate (ORR) was 100%, with 93.8% achieving stringent complete response (sCR).
Safety: After the infusion of Eque-cel, the incidence of grade 1-2 cytokine release syndrome (CRS) was 68.8%, no grade 3 or above CRS was observed, and no immune effector cell-related neurotoxicity syndrome (ICANS) or other neurological toxicities occurred. The median time of CRS occurrence was the 7th day after infusion (range: 2-9 days), and the median duration of CRS was 3 days (range: 1-8 days). The most common grade 3 or above drug-related adverse event wase blood cell count reduction, and the incidence of grade 3 or above infectious disease adverse events was 25.0%.
PK/PD: The median peak time of CAR copy number in peripheral blood was 10 days after infusion (range: 7-21 days), with a median peak level of 79,681.299 copies/μg DNA. 81.25% of subjects achieved clearance of free B-cell maturation antigen (sBCMA) within one month after infusion; the median peak time of cytokine detection IL-6 and CRP after infusion were the 7th and 10th day, respectively, and the serum ferritin level did not change significantly.
Professor Lijuan Chen from Jiangsu Province Hospital stated: " Eque-cel, as a novel fully human BCMA CAR-T therapy, has shown encouraging efficacy and safety in high-risk patients with newly diagnosed multiple myeloma who are ineligible for transplantation. This is the world's first report on CAR-T therapy being used as a first-line treatment in this specific patient population. For NDMM patients who are not suitable for transplantation, the application of CAR-T therapy as a first-line treatment is expected to further improve the remission rate, extend survival, and improve patient prognosis compared to traditional chemotherapy and other targeted drug treatments. This allows us to see the application potential of Eque-cel in the front-line treatment of MM. Advancing CAR-T therapy to the first line will provide patients with more diverse and promising treatment options. With further research and the continuous improvement of treatment strategies, we look forward to CAR-T therapy benefiting more patients in the future."
Professor Bing Chen from Nanjing Drum Tower Hospital stated: "High-risk newly diagnosed multiple myeloma patients have a poor prognosis in standard first-line treatment. For high-risk NDMM patients who do not meet the conditions for ASCT, Eque-cel has shown superior efficacy and safety, achieving deep and sustained remission, with all patients achieving MRD negativity. This opens up a new approach to reverse the poor prognosis of high-risk myeloma patients. Moreover, compared with relapsed/refractory multiple myeloma (RRMM) patients, the incidence and severity of CRS in high-risk NDMM patients treated with Eque-cel are lower, showing a more favorable safety profile. We will further investigate the clinical benefits of Eque-cel for high-risk newly diagnosed multiple myeloma patients with longer follow-up."
About IASO Bio
IASO Bio is a biopharmaceutical company engaged in the discovery and development of novel cell therapies and biologics for oncology and autoimmune diseases. IASO Bio possesses comprehensive capabilities spanning the entire drug development process, from early discovery to clinical development, regulatory approval, and commercial production.
The pipeline in the company includes a diversified portfolio of over 10 novel products, including Equecabtagene Autoleucel (a fully human BCMA CAR-T injection). Equecabtagene Autoleucel received New Drug Application (NDA) approval from China's National Medical Products Administration (NMPA) and U.S. FDA IND approval for the treatment of RRMM.
Leveraging its strong management team, innovative product pipeline, GMP production, as well as integrated manufactural and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfil unmet medical needs to patients in China as well as around the world. For more information, please visit http://www.iasobio.com or www.linkedin.com/company/iasobiotherapeutics.
