Full Press Release Details
Ascentage Pharma to Present Data from Two Clinical
Studies for Bcl-2 Inhibitor Lisaftoclax, Including an Oral Report, at ASH 2025
ROCKVILLE, Md. and SUZHOU, China, November
3, 2025 - Ascentage Pharma Group International Inc. (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical
company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs
in cancer, announced that the latest results from two clinical studies of its novel drug, lisaftoclax (APG-2575), have been selected for
presentations, including an oral report, at the 67th American Society of Hematology (ASH) Annual Meeting. This is the fourth consecutive
year in which clinical results on lisaftoclax have been selected by the ASH Annual Meeting. This year, data from multiple clinical and
preclinical studies on three of the company's investigational drug candidates (lisaftoclax, olverembatinib, and APG-5918) have been
selected for presentations at the ASH Annual Meeting.
Developed by Ascentage Pharma, lisaftoclax is
an orally available Bcl-2 inhibitor. Early data from the studies have demonstrated effects on hematologic malignancies and solid tumors.
Lisaftoclax is being commercialized in China following National Medical Products Administration (NMPA) approval for the treatment of adult
patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy
including Bruton's tyrosine kinase (BTK) inhibitors. At this year's ASH Annual Meeting, Ascentage Pharma will present an oral
report featuring the latest results from a registrational Phase II study of lisaftoclax monotherapy in patients with relapsed/refractory
(R/R) CLL/SLL. Moreover, Ascentage Pharma will present a poster featuring the latest data of lisaftoclax in combination with azacitidine
(AZA) in patients with newly diagnosed (ND) or prior venetoclax-exposed myeloid malignancies.
The ASH Annual Meeting is one of the largest gatherings
of the international hematology community, aggregating the latest scientific research on the pathogenesis and clinical treatment of hematologic
diseases. The 67th ASH Annual Meeting will take place on December 6-9, 2025, local time, both online and in-person in Orlando, Florida.
Dr. Yifan Zhai, Chief Medical Officer of Ascentage
Pharma, said, "Lisaftoclax has demonstrated efficacy and manageable safety profiles across numerous studies to-date. Lisaftoclax
is currently being evaluated in four global registrational Phase III studies. At ASH 2025, the latest clinical data supporting lisaftoclax
were once again selected for presentations, including an oral report, underscoring the drug's therapeutic potential in hematologic
diseases. We are pleased that multiple studies of our key drug candidates have been selected for presentation at the ASH Annual Meeting,
demonstrating Ascentage Pharma's robust capabilities in global innovation and clinical development. We are eager to share more detailed
results during the conference and will continue to accelerate our clinical development programs in order to bring more treatment options
to patients as soon as possible."
An overview of presentations featuring Ascentage
Pharma's drug candidates at ASH 2025:
| Format | Drug Candidate | Abstract Title | Abstract# |
| Oral Presentation | Lisaftoclax APG-2575 | Results of a registrational phase 2 study of lisaftoclax monotherapy for treatment of patients (pts) with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who had failed Bruton's tyrosine kinase inhibitors (BTKis) | 88 |
| Poster Presentation | Lisaftoclax APG-2575 | Results of the APG2575AU101 study of lisaftoclax (APG-2575) combined with azacitidine (AZA) in patients with newly diagnosed (ND) or prior venetoclax-exposed myeloid malignancies | 1641 |
| Olverembatinib HQP1351 | Results of POLARIS-1, a global phase 3 study (Part A): olverembatinib combined with low-intensity chemotherapy in patients with newly diagnosed (ND) Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) | 1574 | |
| Olverembatinib (HQP1351) demonstrates efficacy vs. best available therapy (BAT) in patients (pts) with tyrosine kinase inhibitor (TKI)-resistant chronic-phase chronic myeloid leukemia (CML-CP) in a registrational randomized phase 2 trial: up to 4-year follow-up including patients without T315I mutations | 3788 | ||
| Updated efficacy and safety of olverembatinib (HQP1351) as second-line therapy in patients with chronic phase-chronic myeloid leukemia (CP-CML) | 3782 | ||
| Preclinical and clinical Study of olverembatinib in patients with myeloid/lymphoid neoplasms with FGFR1 rearrangement | 1979 | ||
| Olverembatinib-mediated deep remission improves allogeneic stem cell transplantation outcome in patients with blast crisis chronic myeloid leukemia: First real-world practice report | 1999 | ||
| The efficacy and safety of switching to olverembatinib or continuing original TKI therapy in CML-CP patients treated with at least two prior TKIs: A prospective, multicenter, control trial | 3779 | ||
| Clinical and molecular features associated with glucolipid metabolic disorders and cardio-/cerebro-vascular adverse events in CML patients receiving olverembatinib therapy | 5561 | ||
| APG-5918 | Embryonic ectoderm development (EED) inhibitor APG-5918 overcomes immunomodulatory drug (IMiD) resistance as monotherapy and synergizes with IMiDs/cereblon E3 ligase modulators (CELMoDs) in preclinical models of multiple myeloma (MM) | 1528 | |
| Abstract Only | Olverembatinib HQP1351 | Single CAR-t infusion during front-line consolidation induces deep and sustained remission in newly diagnosed adult ph+b- ALL: A prospective phase 2 study | 442 |
| Lisaftoclax APG-2575 | BCL-2 inhibition in North American adult T-cell leukemia/lymphoma: Preclinical insights and early clinical outcomes | 3304 |
Study abstracts on lisaftoclax selected for presentations
at the 2025 ASH Annual Meeting are as follows: (for details on the abstracts featuring olverembatinib, please refer to a separate press
release published at the same time)
Results of a registrational phase 2 study of
lisaftoclax monotherapy for treatment of patients (pts) with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma
(CLL/SLL) who had failed Bruton's tyrosine kinase inhibitors (BTKis)
Format: Oral Presentation
Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological:
Treatment of CLL in Relapse and in Richter Transformation
Time: Saturday, December 6, 2025; 10:15 AM - 10:30 AM EST
First Author: Prof. Keshu Zhou, The Affiliated Cancer Hospital
of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China
Presenter: Prof. Keshu Zhou, The Affiliated Cancer Hospital
of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China
This is a pivotal registrational Phase II study (NCT05147467) in patients
with CLL/SLL, with the objective response rate (ORR) as its primary endpoint. Patients in this study were refractory to, relapsed on,
or intolerant of both BTK inhibitors and immunochemotherapy; or failed prior BTK inhibitors and were ineligible for immunochemotherapy.
Results: As of July 25, 2025, among 72 evaluable patients with R/R CLL/SLL, the ORR as confirmed by the independent review
committee (IRC) was 62.5%, the median
progression-free survival (mPFS) was 23.89 months (with a median follow-up of 22.01 months). Among high-risk patients (those with
adverse prognostic genotypes such as del(17p)/TP53 mutation, chromosomal complex karyotype, and unmutated IGHV), the
treatment showed clinically meaningful deep responses. 21.8% of patients achieved minimal residual disease (MRD) negativity in
peripheral blood. In the 11 evaluable patients with bone marrow MRD, 6 achieved MRD-negativity.
Safety Results: Lisaftoclax demonstrated a manageable safety
profile in BTKi-pretreated patients. Frequent grade 3 treatment-related adverse events were hematologic toxicities that included decreased
neutrophil, decreased platelet count, and anemia. No tumor-lysis syndrome (TLS) was reported and no treatment-related deaths occurred
Conclusion: Lisaftoclax monotherapy demonstrated significant
and durable clinical efficacy and a manageable safety profile in patients with heavily-pretreated BTK-refractory R/R CLL/SLL, underscoring
its utility as a potential new treatment option.
Poster Presentation:
Results of the APG2575AU101 study of lisaftoclax
(APG-2575) combined with azacitidine (AZA) in patients with newly diagnosed (ND) or prior venetoclax-exposed myeloid malignancies
Format: Poster Presentation
Session: 616. Acute Myeloid Leukemias: Investigational Drug
and Cellular Therapies: Poster I
Time: Saturday, December 6, 2025; 5:30 PM - 7:30 PM EST
First Author: Dr. Tapan Kadia, Department of Leukemia, The University
of Texas MD Anderson Cancer Center
Presenter: Dr. Tapan Kadia, Department of Leukemia, The University
of Texas MD Anderson Cancer Center
Efficacy Results as of July 1, 2025:
Safety Results: No dose-limiting toxicities (DLTs) were reported
in part one for dose-escalation or part two for dose-expansion. Common grade 3 treatment-emergent adverse events (TEAEs) included
neutropenia (41.7%), febrile neutropenia (35.0%), thrombocytopenia (26.2%), anemia (17.5%).
Conclusion: These preliminary clinical data show that the combination
regimen of lisaftoclax plus AZA holds promise in overcoming venetoclax resistance, therefore potentially offering a new treatment option
to patients with AML/HR MDS.
About Ascentage Pharma
Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) ("Ascentage
Pharma" or the "Company") is a global, commercial stage, integrated biopharmaceutical company engaged in the discovery,
development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer. The Company has built a
rich pipeline of innovative drug products and candidates that includes inhibitors targeting key proteins in the apoptotic pathway, such
as Bcl-2 and MDM2-p53, as well as next-generation kinase inhibitors.
The lead asset, olverembatinib, is the first novel 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. All indications are
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 patients with newly diagnosed
Ph+ ALL and SDH-deficient GIST patients.
second approved product, lisaftoclax, is a novel Bcl-2 inhibitor for the treatment of various hematologic malignancies. Lisaftoclax is
being commercialized in China following National Medical Products Administration (NMPA) approval for the treatment of adult patients with
chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy including
Bruton's tyrosine kinase (BTK) inhibitors. The Company is currently
conducting four global registrational Phase III trials: the FDA-cleared GLORA study of lisaftoclax in combination with BTK inhibitors
in patients with CLL/SLL previously treated with BTK inhibitors for more than 12 months with suboptimal response; the GLORA-2 study in
patients with newly diagnosed CLL/SLL; the GLORA-3 study in newly diagnosed, elderly and unfit patients with acute myeloid leukemia (
AML); and the GLORA-4 study in patients with newly diagnosed higher-risk myelodysplastic syndrome (HR MDS), a study that was simultaneously
cleared by the US FDA, the EMA of the EU, and China CDE.