Sintilimab for relapsed/refractory classical Hodgkin’s lymphoma: Extended follow-up on the multicenter, single-arm phase II ORIENT-1 study.

Authors

null

Hang Su

The 307th Hospital of Military Chinese People's Liberation Army, Beijing, China

Hang Su , Yongping Song , Wenqi Jiang , Xiuhua Sun , Wenbin Qian , Wei Zhang , Yuhuan Gao , Zhengming Jin , Jianfeng Zhou , Chuan Jin , Liqun Zou , Lugui Qiu , Wei Li , Jianmin Yang , Ming Hou , Shan Zeng , Peng Liu , Yuankai Shi , Hui Zhou , Shuyan Wang

Organizations

The 307th Hospital of Military Chinese People's Liberation Army, Beijing, China, Department of Hematology, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China, State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou, China, Department of Oncology, Second Hospital of Dalian Medical University, Dalian, China, The First Affiliated Hospital of Medical School of Zhejiang University, Hangzhou, China, Peking Union Medical College Hospital, Beijing, China, Fourth Hospital of Hebei Medical University, Shijiazhuang, China, The First Affiliated Hospital of Soochow University, Suzhou, China, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China, Cancer Hospital Affiliated to Guangzhou Medical University, Guangzhou, China, West China Hospital of Sichuan University, chengdu, China, Blood Institute of the Chinese Academy of Medical Sciences, Tianjin, China, The Cancer Center, The First Hospital of Jilin University, Jilin, China, ChangHai Hospital, Shanghai, China, Qilu Hospital of Shandong University, Jinan, China, Department of Oncology, Xiangya Hospital, Central South University, Changsha, China, Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, China, Innovent Biologics (Suzhou) Co., Ltd., Suzhou, China

Research Funding

Pharmaceutical/Biotech Company

Background: Classical Hodgkin’s lymphoma (cHL) is characterized by chromosome 9p24.1 alterations and PD-1 ligand overexpression. Sintilimab, a programmed death-1 checkpoint inhibitor, has demonstrated efficacy in relapsed/refractory cHL after the primary analysis of the ORIENT-1 study. Here, we report the updated safety and efficacy prolines after extended follow-up. Methods: ORIENT-1 is a multicenter, single-arm, phase II study in China. Classical Hodgkin’s lymphoma patients who had failed ≥2 lines of systemic therapy, including autologous hematopoietic stem cell transplantation (HSCT) were enrolled. Sintilimab, 200 mg IV was given every 3 weeks, until disease progression, death, unacceptable toxicity, or withdrawal from study. The primary endpoint was objective response rate (ORR) assessed by an independent radiological review committee (IRRC) according to 2007 IWG criteria. Results: 96 patients were treated. As of the data cutoff on 16 October, 2018 72.9% of patients were continuing treatment with a median follow-up of 14 months. Median number of treatment cycles was 20 (range: 1 to 26). ORR was 85.4% (82/96, 95%CI: 76.7 to 91.8) based on IRRC review. Twenty-eight patients (29.2%) achieved complete response (CR) by PET scan. At the time of analysis, 59 out of 82 patients who had achieved complete or partial response continued to have an on-going response. The median duration of response (DoR) and progression free survival (PFS) have not been reached. The most common treatment-related adverse event (TRAE) was pyrexia (40.6%, 39/96), 92.3% of which was grade 1 or 2. The most common grade 3 or 4 TRAEs were pyrexia (3.1%) and anemia (3.1%). One death occurred which was not considered treatment related. Conclusions: ORIENT-1 study has the largest cohort of cHL patients in China treated with a PD-1. In addition to a high rate of response, sintilimab also demonstrated durable efficacy and favorable long-term safety profile after extended follow-up. Clinical trial information: NCT03114683

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Abstract Details

Meeting

2019 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Track

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Sub Track

Hodgkin Lymphoma

Clinical Trial Registration Number

NCT03114683

Citation

J Clin Oncol 37, 2019 (suppl; abstr 7533)

DOI

10.1200/JCO.2019.37.15_suppl.7533

Abstract #

7533

Poster Bd #

287

Abstract Disclosures