JAMA Oncology Publishes Phase 1b/2 Study Data on IASO Bio's Equecabtagene Autoleucel (Fucaso™)

JAMA Oncology Publishes Phase 1b/2 Study Data on IASO Bio's Equecabtagene Autoleucel (Fucaso™)

By, Admin 8 November 2024

JAMA Oncology Publishes Phase 1b/2 Study Data on IASO Bio's Equecabtagene Autoleucel (Fucaso™) in the Treatment of Relapsed/Refractory Multiple Myeloma

Overview

SHANGHAI and NANJING, China and SAN JOSE, Calif., Nov. 7, 2024 /PRNewswire/ -- IASO Biotherapeutics (""IASO Bio""), a biopharmaceutical company dedicated to discovering, developing, manufacturing and commercializing innovative cell therapy and antibody products, today announced that the results of the phase 1b/2 clinical study FUMANBA-1 of its fully human anti-BCMA CAR-T therapy, Equecabtagene Autoleucel (trade name: Fucaso™), for the treatment of relapsed/refractory multiple myeloma (R/RMM), have been published in the leading medical journal JAMA Oncology. The study evaluated the efficacy and safety of Equecabtagene Autoleucel in patients with R/RMM who had previously received ≥3 lines of prior therapies. The results demonstrated that Equecabtagene Autoleucel achieved a high overall response rate and durable remission in patients, with a favorable safety profile.

Published Clinical Data

  • JAMA Oncology published clinical data on 103 patients who received infusion of Equecabtagene Autoleucel (Fucaso™) as of September 9, 2022,with a median follow-up of 13.8 months (range: 0.4-27.2 months). 
  • In terms of efficacy, among the 101 evaluable patients, the overall response rate (ORR) was 96.0% (97/101), and the stringent complete response/complete response rate (sCR/CR) was 74.3% (75/101). 
  • Among the 89 patients without prior CAR-T therapy, the ORR was 98.9% (88/89), and the sCR/CR rate was 78.7% (70/89). 
  • In these 101 patients, the median time to response was 16 days (range: 11-179), while the median duration of response (DOR) and median progression-free survival (PFS) had not been reached yet. 
  • The 12-month PFS rate was 78.8% (95% CI: 68.6-86.0). Additionally, 95% (96/101) of the patients achieved minimal residual disease (MRD) negativity, with a median time to MRD negativity of 15 days (range: 14-186). 
  • All patients with sCR/CR achieved MRD negativity, and the median duration of MRD negativity had not been reached.

Safety profile: - In terms of safety, 93.2% (96/103) of the patients experienced cytokine release syndrome (CRS), most of which were grade 1 or 2, with only one patient experiencing grade 3 or higher CRS. Only 1.9% (2/103) of the patients developed immune effector cell-associated neurotoxicity syndrome (ICANS), with one case each of grade 1 and grade 2.

Data Presentation at 2023 American Society of Hematology (ASH) Annual Meeting

  • Notably, updated data from this study, as of December 31, 2022, was presented during the 2023 American Society of Hematology (ASH) Annual Meeting. 
  • The median follow-up had increased to 18.07 months, with an ORR of 96.1% among the 103 evaluable patients. 
  • The sCR/CR rate was 77.7%, and all patients who achieved CR or better exhibited 100% MRD negativity. 
  • Among the 91 patients without prior CAR-T therapy, the ORR reached 98.9%, with an sCR/CR rate of 82.4% and an MRD negativity rate of 97.8%. 
  • Notbly, 81.7% of these patients remained MRD-negative at 12 months post-infusion, with a 12-month PFS rate was 85.5%. 
  • In addition, Equecabtagene Autoleucel could showed prolonged persistence in the body, at 12 months post-infusion, 50% of patients had a vector copy number (VCN) above the limit of detection, and 40% still had detectable VCN persistence at 24 months.

From Chinese Academy of Medical Sciences and Peking Union Medical College

  • Professor Lu-gui Qiu, from the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, stated: ""The results of the FUMANBA-1 study demonstrate the encouraging efficacy and safety of Equecabtagene Autoleucel in treating patients with relapsed/refractory multiple myeloma.
  • Its groundbreaking fully human scFv design overcomes the high immunogenicity issues commonly associated with animal-derived CAR-T cells while maintaining optimal affinity for BCMA-expressing tumor cells. Its excellent dissociation kinetics facilitates rapid expansion and long-term persistence of Equecabtagene Autoleucel in vivo.

From Zhejiang University School of Medicine

  • Professor Huang He, from The First Affiliated Hospital, Zhejiang University School of Medicine, stated, ""Equecabtagene Autoleucel (Fucaso™) was approved in China in June 2023. 
  • Over the past year since its launch, it has brought significant survival benefits to patients with relapsed/refractory multiple myeloma in China and from overseas. 
  • Meanwhile, we have accumulated valuable real-world experience, and we expect this innovative therapy to benefit more patients.""

From Huazhong University of Science & Technology

  • Professor Chunrui Li, from Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, stated: ""Equecabtagene Autoleucel is the world's first fully human CAR-T therapy to be approved.
  • It's binding to BCMA, utilizing both heavy and light chains with optimal affinity, facilitates dissociation from BCMA antigen after tumor cell killing, thereby reducing CAR-T cell self-exhaustion. Along with lower immunogenicity, this leads to rapid, deep, and sustained remission in patients with multiple myeloma.

Words from the CMO: IASO Bio

  • Dr. Jie Chen, Chief Medical Officer of IASO Bio, stated: ""We are delighted that the phase 1b/2 clinical study data of Equecabtagene Autoleucel for the treatment of R/RMM has been published in JAMA Oncology. The results of this study, which targeted patients with R/RMM who had previously received ≥3 lines of prior therapies are very inspiring. We thank the FUMANBA-1 research team for their rigorous scientific approach and high-standard execution.” 
  • Currently, IASO Bio is actively conducting and advancing the phase III clinical study (FUMANBA-3) of Equecabtagene Autoleucel for the treatment of multiple myeloma patients who have received 1-2 lines of prior therapies. We anticipate this clinical study, based on clinical data from Chinese patients, will yield positive results soon, bringing new treatment option for more patients.""

About FUMANBA-1 Study

  • FUMANBA-1 is a single-arm, open-label phase 1b/2 registrational clinical study conducted in 14 Chinese centers to assess the efficacy and safety of the Equecabtagene Autoleucel in patients with R/RMM who have received ≥3 lines of prior therapies. 
  • The trial enrolled patients with RRMM who had previously received at least three lines of therapy, including proteasome inhibitors and immunomodulatory agents-based chemotherapy regimens, and had disease progression on their last line of therapy. 
  • Patients who had previously received BCMA CAR-T therapy were also eligible for enrollment.

About Equecabtagene Autoleucel (Fucaso™)

  • Equecabtagene Autoleucel (Fucaso™) is an innovative fully-human anti- BCMA CAR-T cell therapy which uses lentivirus as a gene vector to transfect autologous T cells. 
  • The CAR contains a fully-human scFv, CD8a hinge and transmembrane, and 4-1BB-mediated co-stimulation and CD3ζ activation domains. 
  • Based on rigorous molecular structure screening and comprehensive in vitro and in vivo functional evaluations, Fucaso™ demonstrates rapid and potent efficacy, accompanied by exceptional long-term persistence in vivo, enabling patients to achieve higher and deeper remissions, providing continuous protection and care for those suffering from multiple myeloma.

About IASO Bio

  • IASO Bio is a biopharmaceutical company focused on 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 commercialization.
  • Its pipeline includes a diversified portfolio of over 10 novel products, including Equecabtagene Autoleucel (a fully human BCMA CAR-T injection). 
  • Equecabtagene Autoleucel received Biologics License Application (BLA) approval from China's National Medical Products Administration (NMPA) in June 2023and U.S. FDA IND approval for the treatment of R/RMM in December 2022.