SUZHOU, China and ROCKVILLE, Md. — Ascentage Pharma a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that Prof. Xiaoyuan Gong of the Institute of Hematology and Blood Diseases Hospital, the Chinese Academy of Medical Sciences, has presented the preliminary results from a Phase II study of Ascentage Pharma’s novel drug candidate, olverembatinib, combined with reduced-intensity chemotherapy in treatment-naïve patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), in an Oral Report at the 65th American Society of Hematology (ASH) Annual Meeting, taking place in San Diego, CA, the United States.
The ASH Annual Meeting is one of the largest gatherings of the international hematology community, bringing together the most cutting-edge scientific research and latest data of investigational therapies that represent leading scientific and clinical advances in the global hematology field. Garnering growing interest from the global research community, multiple studies of Ascentage Pharma’s key drug candidates (olverembatinib and lisaftoclax) have been selected for presentations at this year’s ASH Annual Meeting, including two Oral Presentations on olverembatinib. This is the sixth consecutive year in which the clinical results of olverembatinib have been selected for Oral Presentations at the ASH Annual Meeting.
Following the introduction of tyrosine kinase inhibitors (TKIs), the combination of TKIs and intensive chemotherapy has become a widely adopted treatment for patients with Ph+ ALL because it can offer significantly improved prognosis. However, a large number of patients are ineligible for the treatment because of intolerance to intensive chemotherapy. Clinical results featured in this Oral Presentation demonstrated encouraging clinical benefit and favorable tolerability of olverembatinib, a third-generation TKI, when combined with reduced-intensity chemotherapy in patients with Ph+ ALL, with data showing a complete remission/incomplete hematologic recovery (CR/CRi) rate of 100% in patients treated with the olverembatinib combination regimen; a complete molecular response (CMR) rate of 62.2% in patients who received three cycles of the treatment that was free of intensive chemotherapy or immunotherapy; and a favorable tolerability profile. Compared to the existing data on TKI plus intensive chemotherapy combinations, patients on this combination regimen have a lower need for transfusion and a reduced incidence of infections.
Olverembatinib is a global best-in-class novel drug developed by Ascentage Pharma. As the first and only approved third-generation BCR-ABL inhibitor in China, olverembatinib has been approved for the treatment of adult patients with TKI-resistant chronic-phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation and adult patients with CML-CP resistant and/or intolerant to first- and second-generation TKIs. Olverembatinib is being jointly commercialized in China by Ascentage Pharma and Innovent Biologics.
Prof. Xiaoyuan Gong, commented, “The introduction of high-potency TKIs has made it a real possibility to treat patients with Ph+ ALL with reduced-intensity chemotherapy, or even without chemotherapy, while achieving improved efficacy and safety. As a third-generation TKI, olverembatinib has shown impressive therapeutic potential for the treatment of Ph+ ALL and for its role as a key part of chemotherapy-free regimens.”
“In this study, olverembatinib combined with reduced-intensity chemotherapy continued to demonstrate promising clinical benefit in patients with Ph+ ALL, once again indicating the potential superiority of this third-generation TKI over other TKIs and that an era of chemotherapy-free treatment for patients with Ph+ ALL might be on the horizon,” said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. “Remaining committed to the mission of addressing unmet clinical needs in China and around the world, we will expedite our clinical development programs to bring safe and effective therapies to patients in need.”
About Olverembatinib
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, 2 FTDs, and 2 Rare Pediatric Disease (RPD) Designations from the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of the company’s investigational drug candidates.
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 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.
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