GLS-010, a novel anti-PD-1 mAb in Chinese patients with relapsed or refractory classical Hodgkin’s lymphoma: Preliminary result of a phase II clinical trial.

Authors

null

Yuqin Song

Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), the Department of Lymphoma, Peking University Cancer Hospital & Institute, Beijing, China

Yuqin Song , Jun Zhu , Ningjing Lin , Chen Zhang , Mingzhi Zhang , Hai Bai , Jie Cui , Hui Liu , Xiaoyan Ke , Yongsheng Jiang , Zhihui Zhang , Ying Zhang , Lihong Liu , Aimin Zang , Chris Chen , Jing Li , Hong Du , Baotong Meng , Kehui Xu , Haijin Meng

Organizations

Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), the Department of Lymphoma, Peking University Cancer Hospital & Institute, Beijing, China, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital & Institute, Beijing, China, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China, Lanzhou General Hospital, Lanzhou Command of PLA, Lanzhou, China, Gansu Provincial Cancer Hospital, Lanzhou, China, Beijing Hospital, Beijing, China, The Third Affiliated Hospital of Beijing Medical University, Beijing, China, Tongji Hospital ,Tongji Medical College Huangzhong Univesity of Science&Technology, Wuhan, China, Sichuan Provicial Cancer Hospital, Chengdu, China, Affiliated Hospital of Guangdong Medical University, Guangzhou, China, Fouth Hospital of Hebei Medical University,Tumor Hospital of Hebei Province, Shijiazhuang, China, The Affiliated Hospital of Hebei University, Baoding, China, WuXi Biologics (Shanghai) Co., Ltd., Shanghai, China, Guangzhou Gloria Biosciences Co., Ltd., Beijing, China

Research Funding

Pharmaceutical/Biotech Company

Background: GLS-010 is a novel fully human anti-PD-1 mAb. Previous Phase 1 study exhibited favorable result of tolerance, preliminary efficacy and 240mg fixed dose q2w was selected as Recommended Phase 2 Dose (RP2D). This Phase 2 clinical trial is aimed to further evaluate the safety and efficacy profile of GLS-010 in Chinese patients(pts) with relapsed or refractory classical Hodgkin’s Lymphoma( r/r cHL). Here we reported the preliminary result. Methods: All pts enrolled received GLS-010 240mg every 2 weeks. Tumor response was assessed by Lugona 2014 every 8 weeks. Adverse events (AEs) were graded by NCI CTCAE v4.03. Results: Until Jan 30th 2019, 39 pts were enrolled in this ongoing study. The median dosing number was 4 (range: 1~12). 17 pts received response evaluation. Of 17 evaluable subjects, an objective response was reported in 15 patients (88.3%), including 4(23.5%) pts with a complete response(CR) and 11 pts(64.7% )with a partial response(PR), 1 patient(5.9%) with stable disease(SD)and 1 remaining patient(5.9%) with unconfirmed progressive disease(PD)(observed stable disease(SD) in the first assessment).The most common treatment related AEs included Neutrophil count decreased (10/32), White blood cell count decreased (7/32), Fever (6/32), Alanine aminotransferase increased (4/32), etc. Treatment–related grade 3-5 AEs include Neutrophil count decreased (2/6), Interstitial lung disease (1/6), Influenza like illness (1/6). Conclusions: GLS-010 showed impressive therapeutic activity and an acceptable safety profile in Chinese r/r cHL patients. Current evidence support further development of GLS-010 in this and more indications. Clinical trial information: NCT03655483

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Abstract Details

Meeting

2019 ASCO Annual Meeting

Session Type

Publication Only

Session Title

Developmental Immunotherapy and Tumor Immunobiology: Publication Only

Track

Developmental Therapeutics—Immunotherapy

Sub Track

Immune Checkpoint Inhibitors

Clinical Trial Registration Number

NCT03655483

Citation

J Clin Oncol 37, 2019 (suppl; abstr e14072)

DOI

10.1200/JCO.2019.37.15_suppl.e14072

Abstract #

e14072

Abstract Disclosures