Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in discovering, developing, and commercializing therapies to address global unmet medical needs primarily for malignancies, today announced that Prof. Weiming Li, of Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, has presented the latest clinical data of its novel drug candidate, olverembatinib (HQP1351), as a second-line therapy in patients with chronic-phase chronic myeloid leukemia (CP-CML), in an Oral Report at the 66th 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, results from multiple clinical and preclinical studies on four of Ascentage Pharma's drug candidates (olverembatinib, lisaftoclax, APG-2449, and APG-5918) have been selected for presentations, including two Oral Reports, at this year's ASH Annual Meeting. Furthermore, this is the seventh consecutive year for studies of olverembatinib to be selected for Oral Reports at the meeting.
Results released through the Oral Report are the first batch of data of olverembatinib as a second-line therapy in patients with non-T315I-mutant CP-CML, which indicated that the drug may offer a safe and effective second-line therapy to patients with CP-CML, especially those who had failed on second-generation TKIs in the first-line setting. These data showed that, in patients with CP-CML who were resistant/intolerant to one prior line of TKIs, olverembatinib demonstrated a complete cytogenetic response (CCyR) rate of 74.1%, a major molecular response (MMR) rate of 40.6%; and in patients who had been treated with second-generation TKIs in the first-line setting, olverembatinib demonstrated a CCyR rate of 78.9% and an MMR rate of 43.5%, with efficacy improved over time. In terms of safety, olverembatinib showed a profile similar to that was previously reported. The study did not observe any new safety signals or report any arterial occlusive events (AOEs) or venous thromboembolisms (VTEs).
As the first approved third-generation BCR-ABL inhibitor in China, olverembatinib has already been approved for the treatment of adult patients with tyrosine kinase inhibitor (TKI)-resistant CP-CML or accelerated-phase (AP-) CML harboring the T315I mutation; and adult patients with CP-CML resistant to and/or intolerant of first- and second-generation TKIs. Olverembatinib is being jointly commercialized in China by Ascentage Pharma and Innovent Biologics.
Prof. Weiming Li, the principal investigator of the study, commented, "Among patients with CP-CML, it is a common situation in which patients need to switch to another therapy after failing the first-line treatment with TKIs, and the efficacy of first- and second-generation TKIs often falls short of the desired outcome. Therefore, patients have the desperate need for more second-line therapies that can offer higher efficacy. This is what propelled us to design such a study to evaluate the efficacy and safety of olverembatinib as a second-line therapy in patients with non-T315I-mutant CP-CML.
At the meeting, we released the first dataset of olverembatinib as a second-line therapy for patients with non-T315I-mutant CP-CML. These data showed that, olverembatinib as a second-line treatment offers promising responses and potential clinical benefits, as well as favorable safety and tolerability, especially in patients who had received second-generation TKIs in the first-line setting, thus suggesting that olverembatinib can potentially provide a new strategy for the second-line treatment of patients with CML.
In the future, we hope to release more clinical data that can support the adoption of olverembatinib for the second-line treatment and guideline inclusions. We will strive to bring a better new treatment option to patients and their physicians."
Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, said, "When the very first batch of clinical data of olverembatinib came out ...
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