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.
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