Full Press Release Details
Live from ASCO 2025 | Ascentage Pharma Releases
Data on Alrizomadlin Monotherapy and Combinations in Solid Tumors
ROCKVILLE, Md. and SUZHOU, China, June 2, 2025
- Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global biopharmaceutical company dedicated to addressing unmet medical needs in
cancers, announced that it has released the latest clinical data from its Phase II study of the MDM2-p53 inhibitor alrizomadlin (APG-115)
as a single agent or in combination with PD-1 inhibitor toripalimab in patients with advanced adenoid cystic carcinoma (ACC) or other
solid tumors in a poster presentation at the 61st American Society of Clinical Oncology (ASCO) Annual Meeting. Alrizomadlin
is the first MDM2-p53 inhibitor to enter clinical development in China and a key investigational drug candidate in Ascentage Pharma's
apoptosis-targeted pipeline with global first-in-class potential.
The ASCO Annual Meeting showcases the most cutting-edge
research in clinical oncology and state-of-the-art advanced cancer therapies and is the world's most influential and prominent scientific
gathering of the clinical oncology community. Returning to the ASCO Annual Meeting for the eighth consecutive year, Ascentage Pharma has
garnered growing interest from the global research community. This year, two studies of the Bcl-2 inhibitor lisaftoclax (APG-2575) and
the MDM2-p53 inhibitor alrizomadlin, key drug candidates in the company's apoptosis-targeted pipeline, have been selected for presentations,
including an oral presentation, at the ASCO Annual Meeting.
These clinical data on alrizomadlin in ACC and
other solid tumors demonstrated the antitumor activity of alrizomadlin monotherapy in patients with advanced ACC or malignant peripheral
nerve sheath tumor (MPNST). Moreover, alrizomadlin in combination with toripalimab was well tolerated and showed therapeutic potential
in MPNST, biliary-tract cancer (BTC), and liposarcoma (LPS).
Prof. Ye Guo, MD, a Principal Investigator
of the study from the Department of Medical Oncology, Shanghai East Hospital, noted, "ACC is a rare cancer type that lacks effective
treatment options, and the treatment with antiangiogenic tyrosine kinase inhibitors faces certain limitations and safety concerns. At
ASCO 2025, our team presented data of alrizomadlin in patients with ACC that demonstrated an objective response rate (ORR) of 16.7% and
a disease control rate (DCR) of 100%. These results suggest that the targeted inhibition of the MDM2-p53 pathway has antitumor activity
in ACC; therefore, it can potentially offer a new treatment strategy to patients with ACC."
Prof. Ning Li, MD, a Principal Investigator
of the study from the Chinese Academy of Medical Sciences Cancer Hospital, commented, "Currently, there are limited treatment
options for patients with sarcomas such as MPNST and LPS. In this study, alrizomadlin both as a monotherapy and in combination with a
PD-1 therapy, showed favorable antitumor activity in MPNST. The clinical benefit was particularly notable in patients who received the
combination regimen, with two patients with MPNST achieving long-term responses that lasted more than 60 and 96 weeks, respectively. Furthermore,
alrizomadlin in combination with a PD-1 therapy also showed clinical activity in LPS. These results suggest that alrizomadlin monotherapy
and combination regimens may bring clinical benefit to more patients with sarcoma."
Dr. Yifan Zhai, Chief Medical Officer of Ascentage
Pharma, said, "Alrizomadlin is an investigational drug with global first-in-class potential. The clinical data presented at
this year's ASCO Annual Meeting demonstrated the therapeutic potential of alrizomadlin, both as a monotherapy and in combinations,
in ACC and other solid tumors, and underscored the synergistic effects between alrizomadlin and immunotherapies, thus suggesting a promising
therapeutic strategy for various solid tumors. We are focused on addressing unmet clinical needs in China and around the world, and intend
to further accelerate our clinical programs to advance more novel treatment options for patients as soon as possible."
Highlights of this abstract selected for presentation
at ASCO 2025 are as follows:
A Phase 2 Study of Novel MDM2 Inhibitor Alrizomadlin
(APG-115) With or Without Toripalimab in Patients with Advanced Adenoid Cystic Carcinoma (ACC) or Other Solid Tumors
About Ascentage Pharma
Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855) is
a global biopharmaceutical company dedicated to addressing unmet medical needs in cancers. The company has built a rich pipeline of innovative
drug candidates that includes inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53 and next-generation
The lead asset, olverembatinib, is the first third-generation
BCR-ABL1 inhibitor approved in China for the treatment of patients with CML in chronic phase (CML-CP) with T315I mutations, CML in accelerated
phase (CML-AP) with T315I mutations, and CML-CP that is resistant or intolerant to first and second-generation TKIs. It is covered by
the China National Reimbursement Drug List (NRDL). The Company is currently conducting an FDA-cleared, global registrational Phase III
trial, or POLARIS-2, of olverembatinib for CML, as well as global registrational Phase III trials for newly diagnosed Ph+ ALL patients
and SDH-deficient GIST patients.
The second lead asset, lisaftoclax, is a novel
Bcl-2 inhibitor for the treatment of various hematological malignancies. The NDA for the treatment of relapsed and/or refractory CLL and
SLL was accepted with Priority Review designation by China's National Medical Products Administration. The Company is currently
conducting an FDA-cleared, global registrational Phase III trial, or GLORA, of lisaftoclax in combination with BTK inhibitors for patients
with CLL/SLL previously treated with BTK inhibitors for more than 12 months with sub-optimal response, as well as global registrational
Phase III trials for newly diagnosed CLL/SLL, AML and MDS patients.
Leveraging its robust R&D capabilities, Ascentage
Pharma has built a portfolio of global intellectual property rights and entered into global partnerships and other relationships with
numerous leading biotechnology and pharmaceutical companies, such as Takeda, AstraZeneca, Merck, Pfizer and Innovent, in addition to research
and development relationships with leading research institutions, such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute
and the University of Michigan. For more information, visit https://ascentage.com/
Forward-Looking Statements
This press release includes forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, contained
in this press release may be forward-looking statements, including statements that express Ascentage Pharma's opinions, expectations,
beliefs, plans, objectives, assumptions or projections regarding future events or future results of operations or financial condition.
These forward-looking statements are subject to a number of risks and uncertainties as discussed in Ascentage Pharma's filings with
the SEC, including those set forth in the sections titled "Risk factors" and "Special note regarding forward-looking
statements and industry data" in its Registration Statement on Form F-1, as amended, filed with the SEC on January 21, 2025, and
the Form 20-F filed with the SEC on April 16, 2025, the sections headed "Forward-looking Statements" and "Risk Factors"
in the prospectus of the Company for its Hong Kong initial public offering dated October 16, 2019, and other filings with the SEC and/or
The Stock Exchange of Hong Kong Limited we made or make from time to time that may cause actual results, levels of activity, performance
or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking
statements contained in this presentation do not constitute profit forecast by the Company's management.
As a result of these factors, you should not rely
on these forward-looking statements as predictions of future events. The forward-looking statements contained in this press release are
based on Ascentage Pharma's current expectations and beliefs concerning future developments and their potential effects and speak
only as of the date of such statements. Ascentage Pharma does not undertake any obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise.
Hogan Wan, Head of IR and Strategy
Stephanie Carrington