Ascentage Pharma Completes First Patient Dosing in China's Key Registration Phase II Clinical Trial of Bcl-2 Selective Inhibitor APG-2575 for Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Ascentage Pharma (6855.
HK), a leading biopharmaceutical company dedicated to the development of innovative drugs in the therapeutic areas of oncology, hepatitis B and aging-related diseases, announced that the company is developing an original class 1 new drug, Bcl-2 selective inhibitor APG- The Chinese pivotal registration Phase II clinical trial (APG2575CC201) of 2575 in the treatment of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL) has completed the first patient dosing, and is the second entry in the world Registered clinical stage Bcl-2 inhibitor
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APG2575CC201 is a single-arm, open-label pivotal registration Phase II clinical study in R/R CLL/SLL patients evaluating the efficacy and safety of APG-2575
.
The primary endpoint of the study was overall response rate (ORR)
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Based on the current safety and efficacy data of APG-2575, the Center for Drug Evaluation (CDE) of the State Drug Administration has agreed that the research results of APG2575CC201 will support the marketing application of future indications R/R CLL/SLL
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CLL/SLL is a clonal proliferative tumor of mature B lymphocytes and is one of the most common lymphoid tumors in Western countries
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The disease accounts for about 30% of all leukemias in North America and Europe
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The United States Surveillance, Epidemiology, and Prognosis (SEER) program reports that in 2021, there will be 21,250 new cases of CLL in the United States, and 4,320 related deaths will occur at the same time
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In China, 15,167 new CLL cases were reported in 2020
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However, as China enters an aging society and changes in life>
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Although first-line regimens such as immunochemotherapy and BTK inhibitors have significantly improved the initial response rate of CLL/SLL patients, recurrence and drug resistance are still clinical problems
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For patients with relapsed or refractory CLL/SLL, the disease progresses rapidly and the treatment effect is poor.
Therefore, more clinical researches on CLL/SLL are urgently needed to find effective new treatments
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APG-2575 is a novel oral Bcl-2 selective small molecule inhibitor under development by Ascentage Pharma.
It restores the programmed cell death mechanism (apoptosis) of tumor cells by selectively inhibiting Bcl-2 protein, thereby inducing tumor cell apoptosis.
, to achieve the purpose of tumor treatment
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APG-2575 is the first locally developed Bcl-2 selective inhibitor to enter the clinical stage in China, and the second Bcl-2 inhibitor to enter the registration clinical stage in the world
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APG-2575 is currently undergoing clinical studies on various hematological and solid tumors including CLL/SLL in China, the United States, Australia, and Europe
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Dr.
Yifan Zhai, Chief Medical Officer of Ascentage Pharma, said: "The treatment of patients with relapsed/refractory CLL/SLL is an unmet clinical need in the world.

APG-2575 is an important clinical development product in the company's apoptosis product pipeline.
The study has demonstrated favorable safety and efficacy data and has the potential to be 'best in class'
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Following the completion of the first patient enrollment in the pivotal Phase II clinical trial, we will continue to actively advance the clinical development of APG-2575 for New treatment options for CLL/SLL patients in China and around the world will benefit more CLL/SLL patients who have no treatment options as soon as possible
.
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