Sugemalimab Monotherapy for Patients With Relapsed or Refractory Extranodal Natural Killer/T-Cell Lymphoma (GEMSTONE-201): Results From a Single-Arm, Multicenter, Phase II Study

Author:

Huang Huiqiang1ORCID,Tao Rong2ORCID,Hao Siguo2,Yang Yu3,Cen Hong4ORCID,Zhou Hui5,Guo Ye6,Zou Liqun7,Cao Junning8,Huang Yunhong9,Jin Jie10ORCID,Zhang Liling11,Yang Haiyan12,Xing Xiaojing13,Zhang Huilai14,Liu Yanyan15ORCID,Ding Kaiyang16,Qi Qinzhou17,Zhu Xiaoli17,Zhu Dan17,Wang Siyuan17,Fang Teng17,Dai Hangjun17,Shi Qingmei17,Yang Jason17

Affiliation:

1. Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China

2. Department of Hematology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China

3. Department of Lymphoma, Fujian Cancer Hospital and Fujian Medical University Cancer Hospital, Fuzhou, China

4. Department of Medical Oncology, Guangxi Cancer Hospital and of Guangxi Medical University Affiliated Cancer Hospital, Nanning, China

5. Department of Lymphoma and Hematology, Hunan Cancer Hospital, Changsha, China

6. Department of Medical Oncology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China

7. Department of Medical Oncology, State Key Laboratory, Cancer Center, West China Hospital of Sichuan University, Chengdu, China

8. Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China

9. Department of Lymphoma, the Affiliated Cancer Hospital of Guiyang Medical University, Guiyang, China

10. Department of Hematology, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China

11. Department of Lymphoma, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

12. Department of Lymphoma, The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Hangzhou, China

13. Department of Medical Oncology, Liaoning Cancer Hospital and Institute, Shenyang, China

14. Department of Lymphoma, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China

15. Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, China

16. Department of Hematology, Anhui Provincial Cancer Hospital, Hefei, China

17. Clinical Department, CStone Pharmaceuticals (Suzhou) Co Ltd, Suzhou, China

Abstract

PURPOSE Relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL) is a rare and aggressive type of non-Hodgkin lymphoma with limited treatment options. This phase II study evaluated the efficacy and safety of sugemalimab, an anti–PD-L1 monoclonal antibody, in R/R ENKTL. METHODS Eligible patients received sugemalimab 1,200 mg intravenously once every 3 weeks for up to 24 months or until progression, death, or study withdrawal. The primary end point was objective response rate (ORR) assessed by an independent radiologic review committee. Key secondary end points included ORR assessed by the investigators, complete response rate, duration of response, and safety. RESULTS At the data cutoff (February 23, 2022), 80 patients were enrolled and followed for a median of 18.7 months. At baseline, 54 (67.5%) had stage IV disease and 39 (48.8%) had received ≥2 lines of prior systemic therapy. Independent radiologic review committee–assessed ORR was 44.9% (95% CI, 33.6 to 56.6); 28 (35.9%) patients achieved a complete response and seven (9.0%) achieved a partial response, with a 12-month duration of response rate of 82.5% (95% CI, 62.0 to 92.6). Investigator-assessed ORR was 45.6% (95% CI, 34.3 to 57.2), and 24 (30.4%) patients achieved a complete response. Most treatment-emergent adverse events were grade 1-2 in severity, and grade ≥ 3 events were reported in 32 (40.0%) patients. CONCLUSION Sugemalimab showed robust and durable antitumor activity in R/R ENKTL. Treatment was well tolerated with expected safety profile for this drug class.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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