Evidence map›Paper›PMID 36996373›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023

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.

Huiqiang Huang, Rong Tao, Siguo Hao, Yu Yang, Hong Cen, Hui Zhou, Ye Guo, Liqun Zou, Junning Cao, Yunhong Huang and 15 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07502768 (A Multicenter, Open-Label, Seamless Phase Ib/II Study Evaluating the Safety and Efficacy of Tislelizumab in Combination With Zeprumetostat), which is not on this map. Cited by 32 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 1 pooled it
12.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07502768 phase1 / phase2recruitingnot on this mapstarted 2026, after this paper: background citation

A Multicenter, Open-Label, Seamless Phase Ib/II Study Evaluating the Safety and Efficacy of Tislelizumab in Combination With Zeprumetostat (SHR2554) in Patients With Relapsed or Refractory NK/T-Cell Lymphoma

TypeinterventionalSponsorRong TaoRan2026 to 2028Enrolled107ConditionsExtranodal NK/T-cell Lymphoma, NK/T-cell Lymphoma, Relapsed or Refractory NK/T-Cell LymphomaArmsTislelizumab, Zeprumetostat
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 1 synthesis or guideline pooled it, 46 citations in OpenAlex.

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  15. Prognostic value of interim [European radiology · 2025
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  16. Viral oncogenesis in cancer: from mechanisms to therapeutics.Signal transduction and targeted therapy · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors at 16 institutions in 1 country.

Huiqiang HuangDepartment of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.ORCID 0000-0001-7500-8056
Rong TaoDepartment of Hematology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.ORCID 0000-0001-5766-1625
Siguo HaoDepartment of Hematology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Yu YangDepartment of Lymphoma, Fujian Cancer Hospital and Fujian Medical University Cancer Hospital, Fuzhou, China.
Hong CenDepartment of Medical Oncology, Guangxi Cancer Hospital and of Guangxi Medical University Affiliated Cancer Hospital, Nanning, China.ORCID 0000-0003-2232-9213
Hui ZhouDepartment of Lymphoma and Hematology, Hunan Cancer Hospital, Changsha, China.
Ye GuoDepartment of Medical Oncology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.
Liqun ZouDepartment of Medical Oncology, State Key Laboratory, Cancer Center, West China Hospital of Sichuan University, Chengdu, China.
Junning CaoDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Yunhong HuangDepartment of Lymphoma, the Affiliated Cancer Hospital of Guiyang Medical University, Guiyang, China.
Jie JinDepartment of Hematology, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.ORCID 0000-0003-4617-2601
Liling ZhangDepartment of Lymphoma, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Haiyan YangDepartment 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.
Xiaojing XingDepartment of Medical Oncology, Liaoning Cancer Hospital and Institute, Shenyang, China.
Huilai ZhangDepartment of Lymphoma, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.
Yanyan LiuDepartment of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, China.ORCID 0000-0002-3887-0840
Kaiyang DingDepartment of Hematology, Anhui Provincial Cancer Hospital, Hefei, China.
Qinzhou QiClinical Department, CStone Pharmaceuticals (Suzhou) Co Ltd, Suzhou, China.
Xiaoli ZhuClinical Department, CStone Pharmaceuticals (Suzhou) Co Ltd, Suzhou, China.
Dan ZhuClinical Department, CStone Pharmaceuticals (Suzhou) Co Ltd, Suzhou, China.
Siyuan WangClinical Department, CStone Pharmaceuticals (Suzhou) Co Ltd, Suzhou, China.
Teng FangClinical Department, CStone Pharmaceuticals (Suzhou) Co Ltd, Suzhou, China.
Hangjun DaiClinical Department, CStone Pharmaceuticals (Suzhou) Co Ltd, Suzhou, China.
Qingmei ShiClinical Department, CStone Pharmaceuticals (Suzhou) Co Ltd, Suzhou, China.
Jason YangClinical Department, CStone Pharmaceuticals (Suzhou) Co Ltd, Suzhou, China.
Shanghai Jiao Tong University · CNAnhui Provincial Hospital · CNFudan University Shanghai Cancer Center · CNFujian Medical University · CNGuangxi Medical University · CNGuiyang Medical University · CNHunan Cancer Hospital · CNLiaoning Cancer Hospital & Institute · CNShanghai East Hospital · CNSichuan University · CNSun Yat-sen University · CNTianjin Medical University Cancer Institute and Hospital · CNUnion Hospital · CNZhejiang Cancer Hospital · CNZhejiang University · CNZhengzhou University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeRelapsed 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.

methodsEligible 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.

resultsAt 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.

conclusionSugemalimab showed robust and durable antitumor activity in R/R ENKTL. Treatment was well tolerated with expected safety profile for this drug class.

Indexed as

Lymphoma, Extranodal NK-T-CellAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedHumansKiller Cells, NaturalTreatment OutcomeAntibodies, MonoclonalAntibodies, Monoclonal, Humanizedsugemalimab

Identifiers

PMID36996373
PMCPMC10414714
OpenAlexW4361252860

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.