SUZHOU, China and ROCKVILLE,
Md., June 18, 2024 /PRNewswire/ -- Ascentage
Pharma (6855.HK), a global biopharmaceutical company engaged in
developing novel therapies for cancer, chronic hepatitis B (CHB),
and age-related diseases, announced today that it has released
updated data of the Bcl-2 inhibitor lisaftoclax (APG-2575), one of
the company's key drug candidates, combined with novel therapeutic
regimens in patients with relapsed/refractory (R/R) multiple
myeloma (MM) or immunoglobulin light-chain (AL) amyloidosis, in a
poster presentation at the 2024 European Hematology Association
Hybrid Congress (EHA 2024), taking place in Madrid, Spain.
Building on results from the study released for the first time
at the 2023 American Society of Hematology Annual Meeting, the
updated data presented at EHA 2024 continued to show impressive
efficacy and favorable safety of lisaftoclax-based combinations,
particularly the combination with pomalidomide and dexamethasone in
R/R MM. Moreover, the study reported an incidence of Grade 3 or
higher treatment-related neutropenia of 14.3%, which underscored
the regimens' potential in offering patients a safe new treatment
option.
Prof. Sikander Ailawadhi, MD,
from Mayo Clinic and the principal investigator of this study,
commented, "This is a study of lisaftoclax combined with novel
therapeutic regimens in patients with R/R MM or AL amyloidosis.
From the primary analysis, it demonstrated that lisaftoclax +
pomalidomide in R/R MM could achieve ≥very good partial response
(VGPR) rate of 33.3%, and higher VGPR along with increasing
lisaftoclax dosage. Moreover, lisaftoclax based therapy in both R/R
MM and amyloidosis is very well tolerated with Grade 3/4
neutropenia of 14.3%. This convincing data could provide an
alternative treatment option to patients with MM and
amyloidosis."
"It is our pleasure to release the updated data of lisaftoclax
in patients with R/R MM or AL amyloidosis at this year's EHA Hybrid
Congress," said Dr. Yifan Zhai,
Chief Medical Officer of Ascentage Pharma. "These data
underscore the outstanding safety and efficacy profiles of the
combination therapies, once again demonstrating these regimens'
global best-in-class potential. We will actively advance this
clinical development program to bring patients a safe and effective
new treatment option as soon as possible."
The EHA Hybrid Congress is the largest gathering of the
hematology field in Europe. It
showcases the most cutting-edge research and state-of-the-art
innovative therapies, attracting over 10,000 clinical experts and
researchers from more than 100 countries every year. This year, in
addition to the latest data of lisaftoclax, Ascentage Pharma also
released those of the third-generation BCR-ABL1 inhibitor
olverembatinib (HQP1351) and the EED inhibitor APG-5918.
Highlights of the data on lisaftoclax presented at EHA 2024 are
as follows:
Lisaftoclax (APG-2575) Combined with Novel Therapeutic
Regimens in Patients (Pts) with Relapsed or Refractory (R/R)
Multiple Myeloma (MM) or Immunoglobulin Light-Chain (AL)
Amyloidosis
- Abstract#: P917
- Presentation Type: Poster presentation
- Topic: Myeloma and other monoclonal gammopathies –
Clinical
- Date & Time: Friday June 14,
2024, 18:00 - 19:00 CEST
- Presenting Author: Prof. Sikander
Ailawadhi, Mayo Clinic Florida
Highlights:
- Background: R/R MM is incurable, with virtually inevitable
relapse without appropriate therapeutic intervention. AL
amyloidosis is a rare disease that may cause serious organ damage
or death. Lisaftoclax is a novel, potent, selective BCL-2 inhibitor
with clinical benefits in hematologic malignancies and solid tumors
and a low reported incidence of adverse events (AEs).
- Introduction: The aim of this multicenter study was to evaluate
the safety and efficacy of lisaftoclax combined with pomalidomide
and dexamethasone (Arms A and C) or daratumumab, lenalidomide, and
dexamethasone (Arm B) in patients with R/R MM (Arms A and B) or R/R
AL amyloidosis (Arm C).
- Patient enrollment and methods: Patients with an Eastern
Cooperative Oncology Group (ECOG) performance status≤2 were
administered lisaftoclax daily in repeated 28-day cycles.
Pomalidomide, daratumumab, and lenalidomide were administered per
label use. Dexamethasone was administered at 40 mg/day, and
patients aged>75 were administered at the reduced dose of 20
mg/day.
- As of January 25, 2024, 44
patients that included 36 patients with R/R MM and 8 patients with
R/R AL amyloidosis were enrolled in the 3 arms of the study
(Arms A, B, and C) to receive lisaftoclax at various doses.
- The median (range) age of patients was 70.5 (24-88) years,
68.2% were male, and 65.9% were older than 65 years.
- The median (range) number of lines of prior therapies was 3
(1-19), median (range) time from diagnosis to the first dose of
study drug was 5.5 (1-29) years, and median (range) number of
treatment cycles was 4 (1-26).
- Efficacy results:
- In Arm A, 27 patients with R/R MM were efficacy evaluable.
Among them, 10 had partial response (PR), 7 had very good PR
(VGPR), and 2 had complete response (CR). The overall response rate
(ORR [PR+VGPR+CR]) was 70.4%.
- In Arm B, 2 patients with R/R MM achieved CR.
- In Arm C, 7 patients with R/R AL amyloidosis were efficacy
evaluable, and the ORR was 85.7% (4 VGPRs, 2 CR).
- Safety results:
- Of the 42 patients included in safety analysis, 10 patients
experienced Grade ≥3 treatment-related adverse events (TRAEs),
including neutropenia (14.3%), febrile neutropenia (2.4%). 3
patients experienced serious TRAEs that included febrile
neutropenia, acute kidney injury, and diarrhea with electrolyte
imbalance (1 each).
- A total of 24 patients discontinued treatment because of
disease progression (n=15), treatment-emergent AE (TEAE, n=3),
nonadherence (n=1), or investigator/patient decision (n=5).
- Conclusions: Lisaftoclax plus novel therapeutic regimens was
well tolerated and demonstrated preliminary antitumor activity in
patients with either R/R MM or AL amyloidosis.
*Lisaftoclax is an investigational drug that has not been
approved in any country and region.
About Ascentage Pharma
Ascentage Pharma (6855.HK) is a globally focused
biopharmaceutical company engaged in developing novel therapies for
cancers, chronic hepatitis B, and age-related diseases. On
October 28, 2019, Ascentage Pharma
was listed on the Main Board of the Stock Exchange of Hong Kong
Limited with the stock code 6855.HK.
Ascentage Pharma focuses on developing therapeutics that inhibit
protein-protein interactions to restore apoptosis, or programmed
cell death. The company has built a pipeline of 9 clinical drug
candidates, including novel, highly potent Bcl-2, and dual
Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and
MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors
(TKIs). Ascentage Pharma is also the only company in the world with
active clinical programs targeting all three known classes of key
apoptosis regulators. The company is conducting more than 40 Phase
I/II clinical trials, including 5 global registrational phase III
studies, in the US, Australia,
Europe, and China. Ascentage Pharma has been designated
for multiple Major National R&D Projects, including five Major
New Drug Projects, one New Drug Incubator status, four Innovative
Drug Programs, and one Major Project for the Prevention and
Treatment of Infectious Diseases.
Olverembatinib, the company's core drug candidate developed for
the treatment of drug-resistant chronic myeloid leukemia (CML) and
the company's first approved product, has been granted Priority
Review Designations and Breakthrough Therapy Designations by the
Center for Drug Evaluation (CDE) of China National Medical Products
Administration (NMPA). To date, the drug had been included into the
China 2022 National Reimbursement
Drug List (NRDL). Furthermore, olverembatinib has been granted an
Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by
the US FDA, and an Orphan Designation by the EMA of the EU. To
date, Ascentage Pharma has obtained a total of 16 ODDs from the US
FDA and 1 Orphan Designation from the EMA of the EU for 4 of the
company's investigational drug candidates.
Leveraging its robust R&D capabilities, Ascentage Pharma has
built a portfolio of global intellectual property rights and
entered into global partnerships with numerous renowned
biotechnology and pharmaceutical companies and research institutes
such as UNITY Biotechnology, MD Anderson Cancer Center, Mayo
Clinic, Dana-Farber Cancer Institute, MSD, and AstraZeneca. The
company has built a talented team with global experience in the
discovery and development of innovative drugs and is setting up its
world-class commercial manufacturing and Sales & Marketing
teams. One pivotal aim of Ascentage Pharma is to continuously
strengthen its R&D capabilities and accelerate its clinical
development programs, in order to fulfil its mission of addressing
unmet clinical needs in China and
around the world for the benefit of more patients.
Forward-Looking Statements
The forward-looking statements made in this article relate only
to the events or information as of the date on which the statements
are made in this article. Except as required by law, Ascentage
Pharma undertakes no obligation to update or revise publicly any
forward-looking statements, whether as a result of new information,
future events, or otherwise, after the date on which the statements
are made or to reflect the occurrence of unanticipated events. You
should read this article completely and with the understanding that
our actual future results or performance may be materially
different from what we expect. In this article, statements of, or
references to, our intentions or those of any of our Directors or
our Company are made as of the date of this article. Any of these
intentions may alter in light of future development.
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