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

Authors

null

Hang Su

The Fifth Medical Center, Chinese PLA General Hospital, 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 , Hongli Zuo

Organizations

The Fifth Medical Center, Chinese PLA General Hospital, Beijing, China, The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, 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, Fouth Hospital of Hebei Medical University,Tumor Hospital of Hebei Province, Shijiazhuang, China, The First Affiliated Hospital of Soochow University, Suzhou, China, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China, The Affiliated Cancer Hospital of Guangzhou Medical University, Guangzhou, China, West China Hospital of Sichuan University, Chengdu, China, Institute of Hematology & Blood Diseases Hospital,Chinese Academy of Medical Sciences, Tianjin, China, The First Bethune 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, Inc., Suzhou, China, Innovent Biologics, Inc., Beijing, China

Research Funding

Pharmaceutical/Biotech Company
Innovent Biologics, Inc., China National Major Project for New Drug Innovation (2017ZX09304015 and 2018ZX09301014009) and CAMS Innovation Fund for Medical Sciences (CIFMS) (2016-I2M-1-001)

Background: 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 profile after long-term 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 objective response rate (ORR) by an independent radiological review committee (IRRC) per IWG 2007 has been reported before. The progression free survival (PFS) by IRRC follow-up data are reported herein. Results: 96 patients were treated. As of the data cutoff on 30 Sep, 2019, 57.3 % patients complete two-year treatment, with a median follow-up of 26.7 months. The median duration of treatment was 24.1 months (range: 0.7 to 24.8). Of 49 patients with progressive disease (PD) by investigator, 39/49 (79.6%) patients received treatment beyond PD, with a median treatment duration after PD of 8.0 months (range: 1.4 to 20.8). The median PFS was 18.6 months (95%CI: 14.4 to 22.3). Median overall survival has not been reached. Two-year OS rate was 96.3% (95%CI: 88.9% to 98.8%). The treatment-related adverse event (TRAE) was reported in 92/96 (95.8%) patients, most (71/96, 74.0%) of which were grade 1-2. The most common grade 3 or 4 TRAEs were pyrexia (3/96, 3.1%), lipase increased (3/96, 3.1%) and lymphocyte decreased (3/96, 3.1%). Conclusions: The results from long-term follow-up showed that, in addition to a high rate of response, sintilimab also demonstrated durable efficacy and favorable long-term safety profile. Considering the high rate (nearly 80%) of treatment beyond PD, IWG 2007 which was used to evaluate PFS may not be a suitable criteria for evaluating the efficacy of anti-PD-1 antibody in cHL. Further investigation and analysis are required. Clinical trial information: NCT03114683.

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Abstract Details

Meeting

2020 ASCO Virtual Scientific Program

Session Type

Poster Session

Session Title

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Track

Hematologic Malignancies

Sub Track

Hodgkin Lymphoma

Clinical Trial Registration Number

NCT03114683

Citation

J Clin Oncol 38: 2020 (suppl; abstr 8034)

DOI

10.1200/JCO.2020.38.15_suppl.8034

Abstract #

8034

Poster Bd #

367

Abstract Disclosures