Olverembatinib administered in Phase III registrational study for first time in treatment-naïve patients with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL)

SUZHOU, China and ROCKVILLE, MD , Oct. 17, 2023 /PRNewswire/ — Ascentage Pharma (6855.HK), a global biopharmaceutical company committed to developing new treatments for cancer, chronic hepatitis B (CHB) and age-related diseases, today announced the registration of Phase III study candidates (HQP1351AG301, NCT06051409) of Ascentage Pharma’s lead drug olverembatinib Combination chemotherapy versus imatinib plus chemotherapy in treatment-naïve patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) has been administered to the first patient. As the best-in-class drug in the world, olverembatinib is expected to become the first tyrosine kinase inhibitor (TKI) approved in China for the first-line treatment of Ph+ ALL.

Ascentage Pharma logo (PRNewsfoto/Ascentage Pharma)

This global multi-center, randomized controlled, open-label, registration phase III study (HQP1351AG301) aims to evaluate the efficacy and safety of olverembatinib combined with chemotherapy and imatinib combined with chemotherapy in patients with newly diagnosed Ph+ ALL.

Ph+ ALL accounts for 20%-30% of all ALL cases in adults and is often associated with high relapse rates, short progression-free survival, and poor prognosis. Before the introduction of TKIs, a class of targeted small molecule compounds, allogeneic hematopoietic stem cell transplantation (allo-HSCT) after achieving complete remission (CR) with chemotherapy was widely used as the first-line treatment for patients with Ph+ ALL.However, the five-year overall survival (OS) rate is less than 30%, and more than 70% of patients relapse before transplantation or cannot receive surgical treatment at all(1).

The clinical application of TKIs has brought a new clinical paradigm to patients with Ph+ ALL.However, first- and second-generation TKIs have known clinical limitations, including high relapse rates and disappointing long-term survival rates, with three- to five-year OS rates of only about 50%.(2). These limitations are mainly caused by low complete molecular response (CMR) and T315I kinase domain mutations, so there is still much room for improvement in the treatment of Ph+ ALL. No TKI has been approved for first-line treatment of Ph+ ALL in China. The current third-generation TKI with stronger efficacy can provide a better prognosis for Ph+ ALL patients by inducing a higher CMR rate and inhibiting T315I mutation.

Ascentage Pharma’s new drug under development, olverembatinib, is an oral third-generation TKI and the first and only approved third-generation BCR-ABL inhibitor in China. Currently, olverembatinib is jointly marketed by Ascentage Pharma and Innovent Biologics. In November 2021, Olverembatinib was approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of adult patients with TKI-resistant chronic phase chronic myelogenous leukemia (CML-CP) or accelerated phase. Chronic myeloid leukemia (CML-AP) with T315I mutation. Previously, olverembatinib was recommended by the Chinese Society of Clinical Oncology (CSCO) Diagnosis and Treatment Guidelines for Hematological Malignancies as a treatment option for Ph+ ALL patients.

(Ovibatinib is an investigational drug and has not yet been approved for any indication outside mainland China)

Professor Zhao Weili, Vice President of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine and Director of Shanghai Institute of Hematology” commented, “Ph+ ALL was once the highest-risk and most difficult-to-treat subtype of leukemia, and the introduction of TKIs has improved outcomes for patients with this disease. However, clinicians face a pressing question: What do TKIs provide? Best efficacy and safety. We hope that HQP1351AG301, a clinical study evaluating the next-generation TKI olverembatinib developed in China, can provide answers to these important questions. “

Professor Chen Suning, deputy director of the Hematology Department of the First Affiliated Hospital of Soochow University and deputy director of the Jiangsu Provincial Institute of Hematology“”

Professor Shen Yang, Deputy Director of the Department of Hematology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine” commented, “Olverembatinib has been approved in China for the treatment of chronic myelogenous leukemia. The HQP1351AG301 trial evaluated olverembatinib in Ph+ ALL, where olverembatinib has shown promising efficacy based on available real-world data. We hope that olverembatinib will provide a new treatment option for Ph+ ALL patients. “

Dr. Zhai Yifan, Chief Medical Officer of Ascentage PharmaHe said, “Currently, long-term survival rates for Ph+ ALL patients remain disappointing, so there is considerable room for improvement. Multiple studies have shown that more effective third-generation TKIs can provide durable responses and better survival for Ph+ ALL patients rate, but no TKI has yet been approved for first-line treatment in China. We are very pleased with this registration phase III study of olverembatinib. This TKI may become the first TKI approved for first-line treatment of Ph+ ALL in China. “You have already Successfully enrolled and dosed the first patient. Next, we will actively promote this clinical project and strive to bring this drug to the market as soon as possible to benefit more patients. “

refer to

(1). Fielding AK, Rowe JM, Richards SM, et ala1. Results from the International ALL Trim MRCUKALIXII/ECOG 2993. Blood, 2009,113: 4489-4496 Prospective outcome data from 267 unselected adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia confirm the pre-imatinib era Superiority of allogeneic transplantation over chemotherapy.
(2). Elias Jabr et al. Treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia in adults—from intensive chemotherapy combinations to chemotherapy-free regimens: a review. JAMA Oncol. 2022 Sep 1;8(9):1340-1348.

About Ascentage Pharma

Ascentage Pharma (6855.HK) is a globally focused biopharmaceutical company dedicated to developing new treatments for cancer, 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 established a pipeline of nine clinical candidates, including novel, highly potent Bcl-2 and dual Bcl-2/Bcl-xL inhibitors, as well as candidates targeting the IAP and MDM2-p53 pathways, as well as next-generation tyrosine Acid kinase inhibitors (TKIs). Ascentage Pharma is also the only company in the world with active clinical programs targeting all three classes of known key regulators of apoptosis. The company is conducting more than 40 Phase I/II clinical trials in the United States, Australia, Europe and China. Ascentage Pharma has been approved for a number of major national R&D projects, including 5 major new drug projects, 1 new drug incubator, 4 innovative drug projects, and 1 major infectious disease prevention and treatment project.

The company’s core drug candidate for the treatment of drug-resistant chronic myelogenous leukemia (CML) and the company’s first approved product, Olverembatinib, received priority review and breakthrough designation from the National Center for Drug Evaluation (CDE) Therapeutics Approved Medical Products Administration (NMPA). Currently, the drug has been included in China’s 2022 National Reimbursement Drug List (NRDL). In addition, olverembatinib has received Orphan Drug Designation (ODD) and Fast Track Designation (FTD) from the US FDA, and Orphan Drug Designation from the EU EMA. As of now, Ascentage Pharma’s four drug candidates have received 16 ODD, 2 FTD, and 2 rare pediatric disease (RPD) designations from the U.S. FDA, as well as 1 orphan drug designation from the European Union EMA.

With strong R&D capabilities, Ascentage Pharma owns global intellectual property rights and has established global partnerships with many well-known biotechnology and pharmaceutical companies and research institutions such as UNITY Biotechnology, MD Anderson Cancer Center, Mayo Clinic, and Dana-Farber Cancer Institute. , MSD and AstraZeneca. The company has built a talented team with global experience in innovative drug discovery and development and is building world-class commercial manufacturing and sales and marketing teams. One of Ascentage Pharma’s core goals is to continuously enhance its research and development capabilities and accelerate clinical development processes to fulfill its mission of solving unmet clinical needs in China and around the world and benefiting more patients.

forward-looking statements

The forward-looking statements contained herein relate only to events or information as of the date stated herein. Except as required by law, Ascentage Pharma undertakes no obligation to publicly update or revise any forward-looking statement after the date the statement is made, whether as a result of new information, future events or otherwise, or to reflect unanticipated events that occur. You should read this article in its entirety and understand that our actual future results or performance may differ materially from our expectations. In this article, statements 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 change based on future developments.

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Company code: Hong Kong: 6855

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