Gls-010, a Novel Anti-PD-1 Mab in Chinese Patients with Relapsed or Refractory Classical Hodgkin Lymphoma: Preliminary Impressive Results of a Phase II Clinical Trial

Song, Yuqin

Oral and Poster Abstracts
624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Poster I

Diseases, Hodgkin Lymphoma, Therapies, Adverse Events, Lymphoid Malignancies, Clinically relevant

Yuqin Song, MD, PhD¹^*, Jun Zhu, BS¹, Ningjing Lin, MD, PhD¹^*, Mingzhi Zhang, MD²^*, Hai Bai, MD³^*, Hui Liu, MD⁴^*, Jie Cui, MD⁵^*, Xiaoyan Ke, MD⁶^*, Huilai Zhang, MD, PhD⁷^*, Lihong Liu, MD⁸^*, Dongmei Yan, MD⁹^*, Yongsheng Jiang, MD¹⁰^*, Aimin Zang, MD¹¹^*, Junyuan Qi, MD¹²^*, Li Wang, MD¹³^*, Zhuogang Liu, MD¹⁴^*, Bing Xu, MD, PhD¹⁵^*, Ying Zhang, MD¹⁶^*, Zhihui Zhang, MD, PhD¹⁷^* and Haijin Meng, MD¹⁸^*

¹Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital & Institute, Beijing, China
²First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
³Lanzhou Military Hospital, Lanzhou, China
⁴Department of Hematology, Beijing Hospital, Beijing, China
⁵Gansu Provincial Cancer Hospital, Gansu, China
⁶Hematology and Lymphoma Research Center, Peking University Third Hospital, Beijing, China
⁷Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin’s Clinical Research Center for Cancer, Tianjin, China
⁸The Fourth Hospital of Hebei Medical University, Shijiazhuang, China
⁹Department of hematology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China
¹⁰Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, China
¹¹The Affiliate Hospital of Hebei Medical University, Baoding, China
¹²Blood Disease Hospital, Tianjin, China
¹³Department of Hematology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Collaborative Innovation Center for Cancer Personalized Medicine, Nanjing, China
¹⁴Shengjing Hospital of China Medical University, Shenyang, China
¹⁵Department of Hematology, The First Affiliated Hospital of Xiamen University and Institute of Hematology, School of Medicine, Xiamen University, Xiamen, China
¹⁶Affiliated Hospital of Guangdong Medical University, Zhanjiang, China
¹⁷Department of Medical Oncology, Sichuan Cancer Hospital, Chengdu, China
¹⁸Guangzhou Gloria Biosciences Co., Ltd., Beijing, China

Introduction: Classical Hodgkin lymphoma (cHL) is characterized by genetic alterations in 9p24.1, leading to overexpression of PD-L1 ligand. GLS-010 is a novel fully human anti-PD-1 monoclonal antibody (mAb) and exhibited favorable results in previous Phase I study. The aim of this study was to evaluate the safety and efficacy profile of GLS-010 in Chinese patients (pts) with relapsed or refractory cHL.

Methods: In this multi-center, single-arm Phase II clinical trial, pts with relapsed or refractory cHL after at least 2 lines of prior systemic chemotherapies were enrolled and treated with GLS-010 240mg every 2 weeks until disease progression, death, unacceptable toxicity or withdraw from the study. Efficacy was assessed with the primary endpoint of objective response rate (ORR) by independent review committee (IRC) per Lugano 2014. Adverse events (AEs) were graded by NCI CTCAE v4.03.

Results: As of April 18, 2020, a total of 85 pts with relapsed or refractory cHL received a median of 14.5 treatment cycles (1 cycle include 2 injections). The pretreatment characteristics of the pts are shown in Table 1. At a median follow-up of 15.8 months, 28.2% (24/85) of pts discontinued treatment. As shown in Table 2, treatment-related adverse events (TRAEs) of any grade occurred in 79 (92.9%) of 85 patients, most of which were Grade 1-2. The most common TRAEs were fever (27/85, 31.8%), neutrophil count decreased (17/85, 20%) and alanine aminotransferase (ALT) increased (17/85, 20%). Grade ≥3 TRAEs occurred in 25 (29.4%) pts, most commonly, hepatic function abnormal (5/85, 5.88%) and hyperuricaemia (4/85, 4.71%). For all the 85 pts, ORR was 90.59% (77/85, 95%CI: 82.30-95.85) with 32.9% (28/85) of patients achieving a CR and 57.6% (49/85) of patients achieving a PR (Table 3). Median duration of response (DoR) and progression free survival (PFS) were not reached yet.

Conclusions: GLS-010 showed impressive anti-tumor activity (ORR=90.59%) and manageable safety profile in Chinese patients with relapsed or refractory cHL, and could be a new safe and effective treatment option.

Disclosures: Meng: Guangzhou Gloria Biosciences Co., Ltd.: Current Employment.

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1163 Gls-010, a Novel Anti-PD-1 Mab in Chinese Patients with Relapsed or Refractory Classical Hodgkin Lymphoma: Preliminary Impressive Results of a Phase II Clinical Trial