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 it has released the safety and efficacy data of the company's novel drug candidate, olverembatinib (HQP1351), in combination the company's investigational novel Bcl-2 inhibitor, lisaftoclax (APG-2575), in children and adolescents with relapsed/refractory Philadelphia chromosome–positive acute lymphoblastic leukemia (R/R Ph+ ALL), in a Poster Presentation at the 66th American Society of Hematology (ASH) Annual Meeting, taking place in San Diego, CA, the United States. This poster, named for the Abstract Achievement Award at ASH 2024, features the first batch of clinical data on the combination of Ascentage Pharma's two key drug candidates.
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.
This study in children and adolescents with R/R Ph+ ALL provides the preliminary evidence revealing the favorable efficacy and safety of olverembatinib in combination with lisaftoclax. These data showed a complete response (CR) rate of 83.3% and measurable residual disease (MRD) negativity rate of 71.4% in patients who were treated with the combination regimen without chemotherapy or immunotherapy.
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. Xiaofan Zhu, the principal investigator of this study from the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, commented, "In recent years, we have seen considerable progress in the treatment of pediatric patients with hematologic diseases in China. However, due to a unique disease profile, the prognosis of patients with Ph+ ALL remains relatively poor, thus leaving much to be explored in the treatment of R/R Ph+ ALL. These preliminary clinical data show that the third-generation BCR-ABL1 inhibitor, olverembatinib, in combination with the novel Bcl-2 inhibitor, lisaftoclax, without chemotherapy or immunotherapy, has demonstrated a compelling CR rate, MRD negativity rate, and favorable tolerability in pediatric patients. We look forward to determining the optimal doses and dosing regimens for the combination therapy as we search for more safe and effective treatment options for pediatric patients with R/R Ph+ ALL."
Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, said, "This regimen, the first combination between olverembatinib and lisaftoclax, two of Ascentage Pharma's key drug candidates, has demonstrated encouraging clinical benefit, favorable safety, rapid onset of actions, as well as higher and deeper responses in absence of chemotherapy or immunotherapy. This suggests that the combination regimen may offer a new treatment option and open an era of chemotherapy-free management for patients with Ph+ ALL. Fulfilling our founding mission of addressing unmet clinical needs in China and around the world, we will expedite the global clinical development of our key drug candidates to bring more safe and effective therapies to patients as soon as possible."
Highlights of the data this study reported at ASH 2024 are as below:
Safety and Efficacy of Olverembatinib (HQP1351) Combined with Lisaftoclax (APG-2575) in Children and Adolescents with Relapsed/Refractory Philadelphia Chromosome–Pos...
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