SHANGHAI and NANJING, China and SAN JOSE,
Calif., Sept. 27, 2024 /PRNewswire/ -- IASO
Biotherapeutics ("IASO Bio"), a biopharmaceutical company dedicated
to discovering, developing, manufacturing and commercializing
innovative cell therapy and antibody products, today announced a
poster presentation of the outcomes of relapsed/refractory
multiple myeloma (R/RMM) patients with renal impairment (RI)
treated with the fully human anti-BCMA CAR-T cell therapy
Equecabtagene Autoleucel (Eque-cel, FucasoTM), from the
pivotal phase 2 FUMANBA-1 study at the 2024 International Myeloma
Society (IMS) Annual Meeting. Results indicate that Eque-cel
achieve equivalent efficacy and safety for R/RMM patients with
renal impairment and improve the renal function as well.
Abstract Number:
P-100
Abstract Title: The Outcomes
of R/R MM Patients with Renal Impairment (RI) Treated with Eque-cel
in the Pivotal Phase 2 FUMANBA-1 Study
Presentation Date:
September 26, 2024(UTC-3)
A total of 91 subjects, all without prior CAR-T treatment, were
enrolled in the FUMANBA-1 study to receive Eque-cel, with a median
follow-up of 18.07 months. Subjects were divided into RI group and
non-RI group, based on creatinine clearance (CrCl) levels at the
time of CAR-T therapy, of which 28 subjects had RI with CrCl
between 40 and 70 ml/min, and 63 belonged to non-RI group, with
CrCl>70 ml/min.
The baseline characteristics in the RI group were comparable to
those in the non-RI group. The RI group achieved a response as
rapid and deep as the non-RI group. Long-term efficacy in the RI
group were not inferior (as shown in Figure1) as non-PI group. In
terms of safety, both group developed cytokine release syndrome
(CRS) Only one case of grade 2 immune effector cell-associated
neurotoxicity syndrome (ICANS) was reported in the non-RI group,
while no cases of ICANS occurred in the RI group. A slightly higher
prevalence of short-term severe cytopenia was noted in the RI
group, but recovered by day 60.
Conclusions: In the FUMANBA-1
study, R/RMM patients with RI could achieved a similarly rapid,
deep, and durable response with Eque-cel treatment without
compromising safety status. Additionally, renal function was
improveddue to the clearance of myeloma cells by Eque-cel.
The principal investigator of this study, Professor Lugui Qiu, from the Institute of Hematology and
Blood Diseases Hospital, Chinese Academy of Medical Sciences and
Peking Union Medical College, and Professor Chunrui Li, from Tongji
Hospital, Tongji Medical College, Huazhong University of Science
& Technology, stated: "In the past, we were concerned about the
potential intolerance of R/R MM patients with impaired renal
function to CAR-T treatment. The current study confirmed that even
in patients with renal impairment, Eque-cel can induce rapid, deep,
and durable remission, with efficacy comparable to that of patients
without renal impairment. This data provides invaluable insights
for clinical treatment with Eque-cel for camplcated case.
Dr. Yongke Zhang, Chief
Scientific Officer of IASO Bio, said: "We are pleased to present
the retrospective study on the use of Eque-cel
(FucasoTM) for treating R/RMM patients with renal
impairment at the IMS Annual Meeting. Data from the FUMANBA-1 study
demonstrated the promising efficacy and safety of Eque-cel in this
patient population, with the added benefit of improving renal
function. We believe CAR-T therapy will offer new therapeutic
options for R/RMM patients with moderate to severe renal function
impairment, enabling broader application in the field of myeloma
treatment."
About FUMANBA-1 Study
The FUMANBA-1 Study is a Phase Ib/II, single-arm, multicenter
study to assess the efficacy and safety of the investigational drug
Equecabtagene Autoleucel, a fully human BCMA CAR-T cell therapy, in
patients with R/R MM who have received 3 or more lines of
treatment.
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 2023
and U.S. FDA IND approval for the treatment of R/RMM in
December 2022.
Leveraging its strong management team, innovative product
pipeline, as well as integrated and high quality manufactural and
clinical capabilities, IASO aims to deliver transformative,
curable, and affordable therapies that fulfil unmet medical needs
to patients in China and around
the world. For more information, please visit
http://www.iasobio.com or
www.linkedin.com/company/iasobiotherapeutics.
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