Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that it has released the updated data from three clinical studies of the company's novel drug candidate, olverembatinib, at the 63rd American Society of Hematology (ASH) Annual Meeting. Prof. Qian Jiang, MD, and Prof. Xiaojun Huang, MD, from the Hematology Department of Peking University People's Hospital are the principal investigators of these studies, of which one study was reported by Prof. Jiang in an oral presentation. This is the fourth consecutive year in which studies of olverembatinib were selected for oral presentation by the ASH Annual Meeting, demonstrating strong recognition of the drug candidate's promising efficacy and safety by the international hematology community.
Olverembatinib is a novel drug developed by Ascentage Pharma and recently received approval in November 2021 in China for the treatment of adult patients with tyrosine kinase inhibitor (TKI)-resistant chronic phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation, thus making olverembatinib the first China-approved third-generation BCR-ABL inhibitor targeting drug-resistant CML.
The ASH Annual Meeting is one of the largest gatherings of the international hematology field, bringing together the latest and most cutting-edge research and other scientific and clinical developments in hematology. This year, abstracts from six studies of the company's drug candidates (olverembatinib, lisaftoclax [APG-2575], and pelcitoclax [APG-1252]) were selected for presentations at the ASH Annual Meeting (information on those abstracts about lisaftoclax and pelcitoclax are available in a separate press release published in parallel).
Prof. Qian Jiang commented: "This year, we reported the long-term follow-up data (with a median duration of follow-up of 39 months) that further validated olverembatinib's promising tolerability and potent and durable efficacy, signifying the drug's best-in-class potential. In addition, we reported compelling data from the CC201 and CC202 study in patients with drug-resistant CML harboring the T315I mutation. These two studies have provided clinical evidence that enabled the marketing authorization for olverembatinib that brought about a clinical breakthrough for patients with drug-resistant CML harboring the T315I mutation in China. We hope this novel therapy will soon benefit more patients in need."
"We are very excited about the approval of olverembatinib in China, announced just prior to this year's ASH Annual Meeting. This year marks the fourth year in which the clinical progress of this drug candidate was selected for oral presentation at the ASH Annual Meeting, a strong indication of the international hematology community's recognition of olverembatinib's therapeutic potential," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "It is worth pointing out that this year, we announced olverembatinib's five-year data from 2016 and 2021 which demonstrated efficacy and safety. As China's first and the world's second third-generation BCR-ABL inhibitor, olverembatinib offers a novel therapy with clear efficacy and improved safety to patients with CML. We hope olverembatinib will soon be made available outside China to patients with drug-resistant CML around the world."
These abstracts on olverembatinib presented at the 2021 ASH Annual Meeting are as follows:
Updated Safety and Efficacy Results of Phase 1 Study of Olverembatinib (HQP1351), a Novel Third-Generation BCR-ABL Tyrosine Kinase Inhibitor (TKI), in Patients with TKI-Resistant Chronic Myeloid Leukemia (CML)
Format: Oral Presentation
Abstract: 311
Session: 632. Chronic Myeloid Leukemia: Clinical and Epidemiological: Mechanisms of resistance and expanded therapies
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