A Global Multicenter, Double-blind, Randomized, Registrational Phase 3 Study of Lisaftoclax (APG-2575) in Combination With Azacitidine (AZA) in Patients With Newly Diagnosed Higher Risk Myelodysplastic Syndrome (HR-MDS) (GLORA-4).

A global multicenter, randomized, double-blind, placebo-controlled, pivotal phase III study. To evaluate overall survival (OS) of Lisaftoclax (APG-2575) combined with azacitidine (AZA) vs. placebo combined with azacitidine in newly diagnosed patients with HR-MDS.

Start Date22 Jan 2025

Sponsor / Collaborator

Ascentage Pharma Group, Inc.

NCT06182969

/ RecruitingPhase 1/2

A Randomized, Double-blind, Placebo-controlled Phase I/II Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of APG-2575 in Patients with Mild-to-moderate Systemic Lupus Erythematosus.

To evaluate the safety, tolerability, pharmacokinetics and pharmacokinetics of multi-dose APG-2575 in mild-to-moderate systemic lupus erythematosus (SLE).

Start Date09 Aug 2024

Sponsor / Collaborator

Ascentage Pharma Group, Inc.

[+1]

NCT06401603

/ RecruitingPhase 1IIT

A Phase I Study of Decitabine, Lisaftoclax, and Olverembatinib in Patients With Advanced Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia

To find the recommended doses of lisaftoclax and olverembatinib that can be given in combination with decitabine to participants with advanced CML and Ph+ AML.

Start Date06 Aug 2024

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+1]

100 Clinical Results associated with Lisaftoclax

100 Translational Medicine associated with Lisaftoclax

100 Patents (Medical) associated with Lisaftoclax

Literatures (Medical) associated with Lisaftoclax

05 Jul 2023·Clinical cancer research : an official journal of the American Association for Cancer Research

Novel BCL-2 Inhibitor Lisaftoclax in Relapsed or Refractory Chronic Lymphocytic Leukemia and Other Hematologic Malignancies: First-in-Human Open-Label Trial.

Article

Author: Ailawadhi, Sikander ; Ahmad, Mohammad ; Davids, Matthew S ; Glass, Laura ; Chen, Zi ; Yang, Dajun ; Huang, Bo ; Liang, Eric ; Wang, Hengbang ; Men, Lichuang ; Li, Mingyu ; He, Zhicong ; Mekala, Divya J ; Collins, Mary C ; Parrondo, Ricardo ; Zhai, Yifan ; Yannakou, Costas K ; Fu, Lei Tommy ; Lasica, Masa ; Paulus, Aneel ; Chanan-Khan, Asher

PURPOSE:

This global phase I trial investigated the safety, efficacy, pharmacokinetics, and pharmacodynamics of lisaftoclax (APG-2575), a novel, orally active, potent selective B-cell lymphoma 2 (BCL-2) inhibitor, in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (R/R CLL/SLL) and other hematologic malignancies (HMs).

PATIENTS AND METHODS:

Maximum tolerated dose (MTD) and recommended phase II dose were evaluated. Outcome measures were safety and tolerability (primary) and pharmacokinetic variables and antitumor effects (secondary). Pharmacodynamics in patient tumor cells were explored.

RESULTS:

Among 52 patients receiving lisaftoclax, MTD was not reached. Treatment-emergent adverse events (TEAEs) included diarrhea (48.1%), fatigue (34.6%), nausea (30.8%), anemia and thrombocytopenia (28.8% each), neutropenia (26.9%), constipation (25.0%), vomiting (23.1%), headache (21.2%), peripheral edema and hypokalemia (17.3% each), and arthralgia (15.4%). Grade ≥ 3 hematologic TEAEs included neutropenia (21.2%), thrombocytopenia (13.5%), and anemia (9.6%), none resulting in treatment discontinuation. Clinical pharmacokinetic and pharmacodynamic results demonstrated that lisaftoclax had a limited plasma residence and systemic exposure and elicited rapid clearance of malignant cells. With a median treatment of 15 (range, 6-43) cycles, 14 of 22 efficacy-evaluable patients with R/R CLL/SLL experienced partial responses, for an objective response rate of 63.6% and median time to response of 2 (range, 2-8) cycles.

CONCLUSIONS:

Lisaftoclax was well tolerated, with no evidence of tumor lysis syndrome. Dose-limiting toxicity was not reached at the highest dose level. Lisaftoclax has a unique pharmacokinetic profile compatible with a potentially more convenient daily (vs. weekly) dose ramp-up schedule and induced rapid clinical responses in patients with CLL/SLL, warranting continued clinical investigation.

01 Feb 2023·Acta pharmacologica Sinica

Discovery and identification of a novel small molecule BCL-2 inhibitor that binds to the BH4 domain

Article

Author: Zheng, Ming-Yue ; Jiang, Hua-Liang ; Song, Jia ; Lu, Cheng-Hao ; Zhang, Ying-Hui ; Yang, Rui-Rui ; Fan, Zi-Sheng ; Zhang, Su-Lin ; Chang, Jie ; Zhou, Jing-Yi

The B-cell lymphoma 2 (BCL-2) protein family plays a pivotal role in regulating the apoptosis process. BCL-2, as an antiapoptotic protein in this family, mediates apoptosis resistance and is an ideal target for cell death strategies in cancer therapy. Traditional treatment modalities target BCL-2 by occupying the hydrophobic pocket formed by BCL-2 homology (BH) domains 1-3, while in recent years, the BH4 domain of BCL-2 has also been considered an attractive novel target. Herein, we describe the discovery and identification of DC-B01, a novel BCL-2 inhibitor targeting the BH4 domain, through virtual screening combined with biophysical and biochemical methods. Our results from surface plasmon resonance and cellular thermal shift assay confirmed that the BH4 domain is responsible for the interaction between BCL-2 and DC-B01. As evidenced by further cell-based experiments, DC-B01 induced cell killing in a BCL-2-dependent manner and triggered apoptosis via the mitochondria-mediated pathway. DC-B01 disrupted the BCL-2/c-Myc interaction and consequently suppressed the transcriptional activity of c-Myc. Moreover, DC-B01 inhibited tumor growth in vivo in a BCL‑2‑dependent manner. Collectively, these results indicate that DC-B01 is a promising BCL-2 BH4 domain inhibitor with the potential for further development.

04 Jan 2023·Clinical cancer research : an official journal of the American Association for Cancer Research

Lisaftoclax in Combination with Alrizomadlin Overcomes Venetoclax Resistance in Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia: Preclinical Studies

Article

Author: Zhang, Kaixiang ; Yang, Dajun ; Tang, Qiuqiong ; Xue, Sheng-Li ; Fang, Douglas D. ; Deng, Jing ; Yin, Yan ; Fu, Chengcheng ; Li, Na ; Wang, Qixin ; Zhai, Yifan ; Zhou, Feng

Abstract:

Purpose::

Despite approval of B-cell lymphoma (BCL)-2 inhibitor venetoclax for certain hematologic malignancies, its broader clinical benefit is curtailed by resistance. Our study aimed to determine if treatment with novel anticancer agents targeting BCL-2 and mouse double minute 2 (MDM2) could overcome venetoclax resistance in preclinical models.

Experimental Design::

Venetoclax-sensitive and venetoclax-resistant acute myeloid leukemia (AML) and acute lymphoblastic leukemia cells and xenograft models were used to evaluate antitumor effects and underlying mechanisms associated with combined BCL-2 inhibitor lisaftoclax (APG-2575) and MDM2 inhibitor alrizomadlin (APG-115).

Results::

The combination exhibited synergistic antiproliferative and apoptogenic activities in TP53 wild-type AML cell lines in vitro. This synergy was further exemplified by deep antitumor responses and prolonged survival in AML cell line–derived and patient-derived xenograft models. Interestingly, the combination treatment resensitized (to apoptosis) venetoclax-resistant cellular and mouse models established via chronic drug exposure or genetically engineered with clinically relevant BCL-2 gene mutations. Synergistic effects in reducing cellular viability and proliferation were also demonstrated in primary samples of patients with venetoclax-resistant AML treated with lisaftoclax and alrizomadlin ex vivo. Mechanistically, alrizomadlin likely primes cancer cells to BCL-2 inhibition-induced cellular apoptosis by downregulating expression of antiapoptotic proteins myeloid cell leukemia-1 and BCL–extra-large and upregulating pro-death BCL-2–associated X protein.

Conclusions::

Lisaftoclax in combination with alrizomadlin overcomes venetoclax resistance mediated by various mechanisms, including BCL-2 mutations. In addition, we posit further, putative molecular mechanisms. Our data rationalize clinical development of this treatment combination in patients with diseases that are insensitive or resistant to venetoclax.

News (Medical) associated with Lisaftoclax

10 Jul 2025

·pipelinereview.com

Ascentage Pharma Announces Its Novel Bcl-2 Inhibitor Lisaftoclax Approved by China NMPA, Ushering in a New Era for the Treatment of CLL/SLL

ROCKVILLE, MD, USA and SUZHOU, China I July 10, 2025 I Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global biopharmaceutical company dedicated to addressing unmet medical needs in cancers, announced that its proprietary novel Bcl-2 selective inhibitor lisaftoclax (APG-2575) has been approved by China’s National Medical Products Administration (NMPA) 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, which makes lisaftoclax the first Bcl-2 inhibitor receiving conditional approval and marketing authorization for the treatment of patients with CLL/SLL in China, and the second Bcl-2 inhibitor approved globally. Lisaftoclax is a proprietary, novel orally administered small-molecule Bcl-2 selective inhibitor developed by Ascentage Pharma to treat patients with malignancies by selectively blocking the antiapoptotic protein Bcl-2 and hence restoring the normal apoptosis process in cancer cells. In the clinical trials, lisaftoclax has shown broad therapeutic potential in multiple hematologic malignancies and solid tumors, particularly in CLL/SLL, both as a monotherapy and in combinations. Furthermore, lisaftoclax is Ascentage Pharma’s second commercialized novel drug following olverembatinib. This approval for lisaftoclax underscores Ascentage Pharma’s outstanding capabilities in global clinical development and innovation, marking another major milestone in the Company’s successful development of its deep pipeline. This approval is based on the results from a pivotal registrational Phase II study (APG2575CC201) that was designed to evaluate the efficacy and safety of lisaftoclax monotherapy in patients with relapsed or refractory CLL/SLL, with the overall response rate (ORR) as the primary endpoint. Lisaftoclax demonstrated compelling efficacy and an ORR that met the prespecified endpoint in patients who were previously treated with BTK inhibitors and/or immunochemotherapy. Moreover, lisaftoclax showed a favorable safety profile with no tumor-lysis syndrome (TLS) occurring during the study, a low incidence of hematologic toxicities which were manageable, and a low incidence of non-hematologic toxicities which were mostly grade 1-2. CLL/SLL is a hematologic malignancy caused by mature B-cell neoplasms. It primarily affects older populations with over 100,000 new diagnoses reported globally each year 1 . In China, where the incidence rate of CLL/SLL is lower than that of the western countries, the disease is occurring at a rapidly rising rate, with a younger age of onset and higher aggressiveness 2 . As the current primary option for the first-line treatment of CLL/SLL, BTK inhibitors have significantly improved treatment outcome for patients. However, BTK inhibitors still face a range of issues such as limited ability to induce deep responses, high risk of relapse in mid-and long-term treatment, toxicities and intolerability associated with prolonged treatment; thus, the need for safer and more effective treatment options for the patients with CLL/SLL. The introduction of Bcl-2 inhibitors has further revolutionized the treatment of CLL/SLL. The apoptosis suppressor factor Bcl-2, commonly overexpressed in a variety of hematologic malignancies, particularly CLL/SLL, is a key mechanism by which tumor cells evade apoptosis. However, the discovery of Bcl-2 inhibitor as a therapeutic target is highly challenging mainly because its mechanism of action is based on the protein-protein interaction (PPI). The binding interface of Bcl-2 is relatively large, making it difficult for small-molecule inhibitors to exert blocking effects. Additionally, the Bcl-2 protein, located on mitochondria with double-membrane structure, is among the most complex and challenging cellular components as it requires drugs to first penetrate the cell membrane before they can further act on the mitochondrial membrane. Prior to this, no Bcl-2 inhibitor had been approved for the treatment of CLL/SLL in China. This approval for lisaftoclax fills a treatment gap in CLL/SLL, bringing renewed hope to many patients in the country. Prof. Jianyong Li, Principal Investigator of the study from the Lymphoma Center at Jiangsu Province Hospital , noted, “CLL/SLL is a common hematologic malignancy in aging societies, and its prevalence has been steadily rising in China. Despite advancements in treatment, patients with CLL/SLL still face a range of challenges such as drug resistance, long-term medical treatment that is difficult to manage, and disappointing response rates. In recent years, drugs targeting pro-apoptotic proteins have received widespread interest in the oncology field while Bcl-2 inhibitors have emerged as a new treatment strategy for patients with CLL/SLL. Globally, Bcl-2 inhibitors have already become a key part of the treatment of CLL/SLL, but no Bcl-2 inhibitor has been approved in China up till now. This approval for the next-generation Bcl-2 inhibitor lisaftoclax represents a timely response to the urgent unmet medical need of this patient population, effectively fulfilling the void for Bcl-2 inhibitors in CLL/SLL in China. As the first China-developed Bcl-2 inhibitor, lisaftoclax has demonstrated favorable efficacy and a unique safety profile, thus providing clinicians a new treatment option that can meaningfully improve the survival of patients with CLL/SLL. In April 2025, supported by its groundbreaking efficacy and safety data in Chinese patients with CLL/SLL, lisaftoclax was included in the 2025 Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Lymphoid Malignancies. The approval and guideline recommendations for lisaftoclax, the only Bcl-2 inhibitor approved in China for the treatment of CLL/SLL, validated the drug as a safe and efficacious new treatment option, underscoring a major advancement in precision therapy for hematologic malignancies in China.” Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma , commented, “We are encouraged by the Chinese drug regulators’ recognition of lisaftoclax’s efficacy and safety, and would like to thank our investigators and their teams, and the patients for participating in the clinical study, for their efforts and trust. This approval for lisaftoclax is a milestone achieved through over a decade of committed research and clinical development by Ascentage Pharma. Lisaftoclax addresses an urgent unmet clinical need and brings a safe and effective new treatment option to patients with CLL/SLL. This represents another big step forward in our patient-centric global innovation. Lisaftoclax has broad therapeutic potential in multiple hematologic malignancies and solid tumors. We will accelerate the global development of this drug in various indications and bring it to more patients as soon as possible.” Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma , said, “Our founding team has over 20 years of research experience in the field of apoptosis and accumulated deep expertise on the Bcl-2 target. This approval for lisaftoclax is a culmination of their dedicated research and a major milestone in our never-ending journey of innovation, further solidifying our leadership in the hematology field. As a proprietary novel drug developed through global innovation, lisaftoclax is a testament to our strength in drug development, bringing much needed change to the global landscape for Bcl-2 inhibitors. Moving forward, Ascentage Pharma will remain steadfastly committed to its mission of addressing unmet clinical needs in China and around the world and aspire to bring more innovative therapeutics to more patients globally.” Ascentage Pharma is currently conducting 4 global registrational Phase III trials of lisaftoclax: GLORA, an FDA-cleared study of lisaftoclax in combination with BTK inhibitors for patients with CLL/SLL previously treated with BTK inhibitors for more than 12 months with suboptimal response, as well as for the patients with newly diagnosed CLL/SLL in the GLORA-2 study, with newly diagnosed, elderly and unfit acute myeloid leukemia (AML) in the GLORA-3 study, and newly diagnosed higher risk myelodysplastic syndrome (MDS) in the GLORA-4 study. *In the United States, lisaftoclax (APG-2575) is an investigational compound and has not been approved by the US FDA. References 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 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. 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 patients with newly diagnosed Ph+ ALL and SDH-deficient GIST patients. The second lead asset, lisaftoclax, is a novel Bcl-2 inhibitor for the treatment of various hematologic malignancies. The NDA for the treatment of relapsed and/or refractory CLL and SLL just received approval by China’s National Medical Products Administration (NMPA). The Company is currently conducting 4 global registrational Phase III trials: the 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 AML; and the GLORA-4 study in patients with newly diagnosed higher risk MDS. 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/ SOURCE: Ascentage Pharma

Clinical ResultPhase 2Drug ApprovalPhase 3Phase 1

25 Jun 2025

·www.echemi.com

Venetoclax Falls Short in 15 Month MDS Survival Challenge but Hope Remains

Venetoclax, approved by the FDA in 2016 for treating 17p-deleted chronic lymphocytic leukemia (CLL), has been a blockbuster drug in hematologic cancers, earning over $2 billion in sales in 2024. Despite its success in acute myeloid leukemia (AML), AbbVie’s ambitions to expand Venetoclax into the myelodysplastic syndrome (MDS) market have faced significant setbacks. MDS, a hematologic malignancy with an average survival of only 15 months and a 5-year survival rate below 20%, presents major challenges for drug development due to heterogeneous disease profiles and the lack of effective models. Current standard treatments, such as hypomethylating agents (HMAs) like azacitidine and decitabine, often result in drug resistance, leaving more than 50% of patients without alternatives. Venetoclax, a BCL-2 inhibitor, offers a chemo-free approach by inducing mitochondrial apoptosis. Encouraged by its success in AML, AbbVie initiated clinical trials targeting MDS. In a Phase 1b trial involving 107 patients, Venetoclax combined with azacitidine showed promising response rates, with 29.9% achieving complete remission (CR) and a median overall survival (OS) of 26 months. However, all patients experienced adverse events, raising concerns about its safety. The drug’s Phase 3 trial, critical for regulatory approval, failed to demonstrate a significant survival benefit for MDS patients. Experts attribute this to MDS's greater reliance on MCL-1 rather than BCL-2, making Venetoclax less effective in this population. Additionally, TP53 mutations, present in up to 90% of MDS patients, further limit efficacy by disrupting DNA repair pathways. Beyond efficacy, Venetoclax’s toxicity profile poses challenges. Its apoptosis-inducing effects harm healthy bone marrow cells, exacerbating anemia and neutropenia in MDS patients, who are already vulnerable to life-threatening infections. Despite this setback, the unmet clinical need in MDS remains significant. Other BCL-2 inhibitors, including Ascentage Pharma’s APG-2575, are showing promising Phase 1 results, with ORR reaching 75% in relapsed/refractory MDS patients. The race to capture the MDS market, estimated in billions of dollars, is far from over.

Clinical ResultPhase 1Drug ApprovalPhase 3Phase 2

09 Jun 2025

·www.einpresswire.com

Thirteen Studies of Ascentage Pharma’s Assets Including Olverembatinib and Lisaftoclax Selected for Presentations at 2025 European Hematology Association Annual Congress

ROCKVILLE, Md. and SUZHOU, China, June 09, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global biopharmaceutical company dedicated to addressing unmet medical needs in cancers, announced that 13 studies of its core assets - including the novel drug olverembatinib (HQP1351), the investigational Bcl-2 inhibitor lisaftoclax (APG-2575), and the investigational EED inhibitor APG-5918 – will be featured in an oral presentation, multiple poster presentations and multiple online publications at the 2025 European Hematology Association (EHA) Annual Congress taking place in Milan, Italy, from June 12-15, 2025. The EHA Annual Congress is the largest gathering of the hematology community in Europe. Attracting more than 10,000 attendees from more than 100 countries every year, the congress showcases cutting-edge research and ground-breaking clinical results in the field of hematology. Oral Presentation Integrating Genomic and Transcriptomic Insights for Predicting Responses and Outcomes in Patients with CML Receiving 3rd-Generation TKI Therapy Abstract#: S162 Session: Biology of CML treatment response and resistance Date and Time: Saturday, 14 June, 17:30-17:45 CEST / Saturday, 14 June, 23:30-23:45 Beijing Time Principal Authors: Prof. Qian Jiang, Peking University People’s Hospital; Dr. Xiaoshuai Zhang, Peking University People’s Hospital Poster Presentations Frontline Chemotherapy-Free Combination of Olverembatinib with Venetoclax and Azacitidine in Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia: Preliminary Outcomes of a Prospective Study Abstract#: PF384 Session: Acute lymphoblastic leukemia – Clinical Date and Time: Friday, 13 June, 18:30-19:30 CEST / Saturday, 14 June, 00:30-01:30 Beijing Time Principal Author: Prof. Xiaowen Tang, The First Affiliated Hospital of Soochow University; Xin Zhang, The First Affiliated Hospital of Soochow University A Phase 2 Study of Olverembatinib for the Treatment of Myeloid/Lymphoid Neoplasms with FGFR1 Rearrangement Abstract#: PF390 Session: Acute lymphoblastic leukemia – Clinical Date and Time: Friday, 13 June, 18:30-19:30 CEST / Saturday, 14 June, 00:30-01:30 Beijing Time Principal Authors: Prof. Suning Chen, The First Affiliated Hospital of Soochow University; Wenzhi Cai, The First Affiliated Hospital of Soochow University Efficacy and Safety of Regimen with Olverembatinib and Blinatumomab for the Frontline Treatment of Ph-Positive or Ph-Like Acute Lymphoblastic Leukemia Abstract#: PS1367 Session: Acute lymphoblastic leukemia – Clinical Date and Time: Saturday, 14 June, 18:30-19:30 CEST / Sunday, 15 June, 00:30-01:30 Beijing Time Principal Authors: Prof. Hongsheng Zhou, Nanfang Hospital, Southern Medical University; Xiuli Xu, Nanfang Hospital, Southern Medical University Combination of Olverembatinib and VP Regimen as First-Line Therapy for Adult Patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Single-Arm, Multicentre, Phase 2 Trial Abstract#: PS1372 Session: Acute lymphoblastic leukemia – Clinical Date and Time: Saturday, 14 June, 18:30-19:30 CEST / Sunday, 15 June, 00:30-01:30 Beijing Time Principal Authors: Prof. Jie Jin, The First Affiliated Hospital, Zhejiang University School of Medicine; Dr. Gaixiang Xu, The First Affiliated Hospital, Zhejiang University School of Medicine Efficacy and Safety of The Third-Generation Tyrosine Kinase Inhibitor Olverembatinib in Combination with Inotuzumab Ozogamicin for the Treatment of Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Patients With Relapsed Disease or Persistent Minimal Residual Disease Bridging to Hematopoietic Stem Cell Transplantation: A Phase II Study Abstract#: PS1387 Session: Acute lymphoblastic leukemia – Clinical Date and Time: Saturday, 14 June, 18:30-19:30 CEST / Sunday, 15 June, 00:30-01:30 Beijing Time Principal Author: Erlie Jiang, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; Xiaoyu Zhang, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Embryonic Ectoderm Development (EED) Inhibitor APG-5918 Exhibits Potent Antitumor Activity and Synergizes with Histone Deacetylase Inhibitor Tucidinostat in Preclinical T-Cell Lymphoma (TCL) Models Abstract#: PS1993 Session: Lymphoma biology & translational research Date and Time: Saturday, 14 June, 18:30-19:30 CEST / Sunday, 15 June, 00:30-01:30 Principal Author: Dr. Eric Liang, Ascentage Pharma Group Inc. Online Publications Alternating Low-Dose Inotuzumab Ozogamicin and Blinatumomab in Maintenance Therapy for Ph+ ALL: A Single-Center Retrospective Analysis Abstract: PB2384 Principal Author: Prof. Zi-Yuan Nie, The Second Hospital of Hebei Medical University Efficacy and Safety of Blinatumomab in Newly-Diagnosed Patients with Ph-Positive/Negative B-Cell Acute Lymphoblastic Leukemia Abstract#: PB2363 Principal Author: Yinqiang Zhang, Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Efficacy and Safety of the Third-Generation TKI Olverembatinib in Relapsed and Persistent MRD Positive Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Patients Abstract#: PB2360 Principal Author: Xinwen Jiang, The Second Hospital of Hebei Medical University Clinical Features and Genetic Abnormalities Predict Outcomes in Patients with Chronic Myeloid Leukemia in the Accelerated-Phase Receiving Olverembatinib Therapy: A Retrospective Multicenter Study Abstract#: PB2701 Principal Author: Mengyao Yuan, Peking University People's Hospital A Real-World Study of Olverembatinib in the Treatment of Chronic Myeloid Leukemia from China: A Single-Center Retrospective Study Abstract#: PB2714 Principal Author: Tian Dong, West China Hospital of Sichuan University Synergistic Effects of Olverembatinib (HQP1351) Combined with Bcl-2 Inhibitor Lisaftoclax (APG-2575) and Bcl-2/Bcl-xL Inhibitor Pelcitoclax (APG-1252) in T-Cell Acute Lymphoblastic Leukemia (T-ALL) Abstract#: PB2341 Principal Author: Bo Peng, Ascentage Pharma (Suzhou) Co., Ltd. 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 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. 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 hematologic 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 suboptimal 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. Contacts Investor Relations: Hogan Wan, Head of IR and Strategy Ascentage Pharma Hogan.Wan@ascentage.com +86 512 85557777 Stephanie Carrington ICR Healthcare Stephanie.Carrington@icrhealthcare.com +1 (646) 277-1282 Media Relations: Sean Leous ICR Healthcare Sean.Leous@icrhealthcare.com +1 (646) 866-4012 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Phase 2Phase 3Priority ReviewNDA

100 Deals associated with Lisaftoclax

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Chronic Lymphocytic Leukemia	China	Suzhou Yasheng Pharmaceutical Co., Ltd.	08 Jul 2025
Small Lymphocytic Lymphoma	China	Suzhou Yasheng Pharmaceutical Co., Ltd.	08 Jul 2025

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
High Risk Myelodysplastic Syndrome	Phase 3	United States	Ascentage Pharma Group, Inc.	22 Jan 2025
High Risk Myelodysplastic Syndrome	Phase 3	China	Ascentage Pharma Group, Inc.	22 Jan 2025
Myelodysplastic Syndromes	Phase 3	China	Suzhou Yasheng Pharmaceutical Co., Ltd.	22 Jan 2025
Acute Myeloid Leukemia	Phase 3	China	Suzhou Yasheng Pharmaceutical Co., Ltd.	11 Jun 2024
Acute Myeloid Leukemia	Phase 3	China	Ascentage Pharma Group, Inc.	11 Jun 2024
Systemic Lupus Erythematosus	Phase 2	China	Ascentage Pharma Group, Inc.	09 Aug 2024
Systemic Lupus Erythematosus	Phase 2	China	Suzhou Yasheng Pharmaceutical Co., Ltd.	09 Aug 2024
Recurrent Chronic Lymphoid Leukemia	Phase 2	China	Ascentage Pharma Group, Inc.	28 Dec 2021
Immunoglobulin Light-Chain Amyloidosis	Phase 2	United States	Ascentage Pharma Group, Inc.	23 Dec 2021
Advanced Malignant Solid Neoplasm	Phase 2	United States	Ascentage Pharma Group, Inc.	13 Aug 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04964518 (APG2575AU101, ASCO2025 \| NEWS) Manual	Phase 1/2	Acute Myeloid Leukemia \| Chronic Myelomonocytic Leukemia \| Mixed phenotype acute leukemia ... View more	97	Lisaftoclax+azacitidine	znvgnfdfvv(pdrhkfapwq) = qiiydelhzq yssdbnptgp (kdkacbwfnz ) View more	Positive	30 May 2025
AACR2025	Not Applicable	pre-TCR/Src signaling \| BCL-2 family proteins	-	Olverembatinib	jfpjjxziek(hprtvjcdfx) = the combination significantly increased the percentage of apoptotic cells compared to either agent alone (p < 0.0001) ferxuoeuba (kxnlveasmr )	Positive	29 Apr 2025
				Lisaftoclax
NCT04215809 (ASH2024) Manual	Phase 1	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma	176	APG-2575	ybzbgycnhi(erazzkdmhx) = Incidence and severity of TEAEs were similar across cohorts. Common (>10%) any-grade TEAEs in all cohorts combined were neutropenia (59 [33.5%]), diarrhea (38 [21.6%]), anemia (27 [15.3%]), and thrombocytopenia (26 [14.8%]). mpilncciti (sxdbpsycdh ) View more	Positive	09 Dec 2024
				APG-2575+Acalabrutinib
NCT04942067 (APG2575MU101, ASH2024) Manual	Phase 1/2	Multiple Myeloma \| Immunoglobulin Light-Chain Amyloidosis	49	Lisaftoclax + pomalidomide + dexamethasone (Arm A)	wowwbevcnp(ruqxpdtaji) = xknsrwcqzk ssiwgkfrct (fyjnmryjci ) View more	Positive	09 Dec 2024
				lisaftoclax and daratumumab, lenalidomide, and dexamethasone (R/R MM + Arm B)	wowwbevcnp(ruqxpdtaji) = nqeovlmohn ssiwgkfrct (fyjnmryjci ) View more
NCT04501120 (APG2575AC101, ASH2024) Manual	Phase 1/2	Myelodysplastic Syndromes	49	Lisaftoclax Azacitidineazacitidine (R/R MDS)	wfdjffweuw(vhudzqthll) = oujdpkrejj lcprmepjbx (rlthknlyhr ) View more	Positive	08 Dec 2024
				Lisaftoclax Azacitidineazacitidine (TN MDS)	pcgfsozzal \| wfdjffweuw(zsghdsegyi) = hrlxsiopyz wffkopaiwp (dqyncpwnhk, 61.5 - 89.2) View more
NCT05495035 (ASH2024) Manual	Phase 1	Philadelphia positive acute lymphocytic leukaemia	10	olverembatinib (EOM)	wmogoalpsp(ydlwaldbfw) = Six of 10 pts experienced grade ≥ 3 hematologic treatment-emergent adverse events, including anemia (3/10), neutropenia (7/10), and thrombocytopenia (3/10). mghvbwhtmw (bfbjqmxgqr ) View more	Positive	07 Dec 2024
				olverembatinib + lisaftoclax (EOC)
PRNewswire Manual	Not Applicable	Multiple Myeloma \| Immunoglobulin Light-Chain Amyloidosis	44	APG-2575+泊马度胺+地塞米松 (MM)	cpmvbylgsz(ifjmkgwzhq) = kulturysdt ftrbiffrqj (fzotpksyhs ) View more	Positive	18 Jun 2024
				APG-2575+达雷妥尤单抗+来那度胺+地塞米松 (MM)	jcigqjqerp(qoolwuuzbe) = epmtkwkewg sudzbqetgx (sjsaygjdnt )
NCT04501120 (ASCO2024) Manual	Phase 1/2	Relapsing acute myeloid leukemia \| Refractory acute myeloid leukemia	72	Lisaftoclax 400 mgAZA mg	eniabcpjkh(rjaasgwzwo) = zjankzutkg qblnwpurir (ynaqtxpsgk, 28.1 - 63.6) View more	Positive	24 May 2024
				Lisaftoclax 600 mgAZA mg	eniabcpjkh(rjaasgwzwo) = gxlvsmlnle qblnwpurir (ynaqtxpsgk, 34.8 - 67.6) View more
NCT04260217 (APG2575WU101, ASCO2024) Manual	Phase 1/2	Waldenstrom Macroglobulinemia MYD88 Gene Mutation Negative \| MYD88 \| CXCR4	46	Lisaftoclax	mbgvbtghlt(wwmfqaoaxw) = hvyuaiepks tzrqphwfbp (pnfhduoxyk, 1 - 28) View more	Positive	24 May 2024
				Lisaftoclax + Ibrutinib	mbgvbtghlt(wwmfqaoaxw) = eeednlnpxt tzrqphwfbp (pnfhduoxyk, 1 - 34) View more
NCT04501120 (APG2575AC101, ASH2023) Manual	Phase 1/2	Myeloid Tumor \| Acute Myeloid Leukemia \| Myelodysplastic Syndromes	115	Lisaftoclax monotherapy	whtypmjxeu(avkwhbbrrs) = yesqqqsqqq mazyiwojtm (mhhakqarhm ) View more	Positive	10 Dec 2023
				Lisaftoclax+LD-HHT (R/R AML)	whtypmjxeu(avkwhbbrrs) = oncixvzpuu mazyiwojtm (mhhakqarhm ) View more

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