On June 8-11, the 28th Annual Conference of the European Blood Association (2023 EHA) in 2023 was grandly held in Frankfurt, Germany in the form of a combination of online + offline!
As an international event in the field of hematology, EHA 2023 brings together the world's top hematology experts to share and discuss the cutting-edge research results in the field of hematology. With the rapid development of hematology in China, more and more mainland scholars have appeared on the international stage, making a loud voice in Chinese academia!
The Chinese Medical Tribune specially invited the team of the Department of Hematology of the First Affiliated Hospital of Soochow University to share the important achievements of the 2023 EHA, and provided the cutting-edge information of the professional conference for doctors in the field of hematology in mainland China for the first time.
Abstract number P626
A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Bcl-2 Inhibitor BGB-11417 in Adult Patients with Mature B-Cell Malignancies
The 2023 EHA hit the scene
▲Professor Li Caixia at the 2023 EHA (abstract number P626)
The study is a multicenter, open-label Phase I study currently underway in China to explore the safety and long-term follow-up of BGB-11417, a drug with higher potential and wider selectivity to inhibit BCL-2-targeted anti-hematological tumor activity (Abstract 2989, ASH2022)) in adults.
By October 2022, 54 patients [34 relapsed/refractory (R/R)-non-Hodgkin lymphoma (NHL): 20 diffuse large B-cell lymphoma (DLBCL), 7 follicular lymphoma (FL), 4 marginal zone lymphoma (MZL), 3tNHL (transformed NHL), and 20 R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)] received ≤640 mg/day.
640 mg/day is the maximum dose for study design, and the maximum tolerated dose (MTD) has not been reached. The median age of enrolled patients was 61 years, with a baseline mean systemic therapy of 2 lines and a follow-up of 6.6 months.
Grade ≥ 3 treatment adverse events (TEAEs) were 53.7%, mainly manifested by neutropenia (25.9%). But there were no associated deaths from TEAE, treatment interruptions, and tumor lysis syndrome.
Of these, 39 patients (27 NHL; 12 patients with CLL/SLL) were evaluated, 5 patients received ORR for NHL and 9 CLL/SLL patients, 9 patients were evaluated for minimal residual disease (MRD), and uMRD4 was achieved in 1 patient receiving an 80 mg dose and 2 patients receiving a 160 mg dose.
The dose of single-agent RP2D in patients with CLL/SLL is 320 mg/day.
This study further confirmed that BGB-11417 was well tolerated, and no increase in dose-related toxicity occurred even after climbing to the maximum dose of 640 mg/d. BGB-11417 monotherapy with R/R CLL/SLL has shown superior efficacy, resulting in remission even at low doses.
This study provides new options for further improving patient outcomes, especially for clinical treatment strategies and technology enhancements.
Professor Wu Depei is the corresponding author
Chief physician, professor, doctoral supervisor
Director of the Department of Hematology, The First Affiliated Hospital of Soochow University
Executive Deputy Director of the National Clinical Research Center for Blood System Diseases
Deputy Director of Jiangsu Institute of Hematology
Director of the Institute of Hematopoietic Stem Cell Transplantation, Soochow University
Member of the 13th National Committee of the Chinese People's Political Consultative Conference
Chairman of the Hematology Branch of the Chinese Medical Association
Vice President of Hematologist Branch of Chinese Medical Doctor Association
Vice Chairman of the Expert Committee of China Hematopoietic Stem Cell Donor Database
Editor-in-Chief of the Chinese Journal of Hematology
Professor Li Caixia is the speaker
Professor, chief physician, doctoral supervisor
Chief physician, Department of Hematology, First Affiliated Hospital of Soochow University
Director of the lymphoma subspecialty of the National Clinical Research Center for Hematological Diseases
Director of the International Special Needs Ward of Hematology
Deputy leader of Hematological Lymphoma Group of Jiangsu Medical Association
Vice Chairman of the Lymphoma Special Committee of Jiangsu Anti-Cancer Association
Vice Chairman of the Intelligent Diagnosis and Treatment Committee of Jiangsu Research Hospital Association
Member of Blood Infection Group of Jiangsu Medical Association
Member of the Lymphocyte Disease Group of the Hematology Branch of the Chinese Medical Association
Member of Hematological Oncology and Gonorrhea Oncology Group of Chinese Anti-Cancer Association
Member of the Expert Committee of China Stem Cell Group
Committee member of CSCO China Anti-Lymphoma Alliance
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