Evidence map›Paper›PMID 37289256›Full record

Trial reportCancer immunology, immunotherapy : CII2023

Efficacy and safety of geptanolimab (GB226) for relapsed/refractory primary mediastinal large B-cell lymphoma: an open-label phase II study (Gxplore-003).

Yuankai Shi, Jie Cui, Hui Zhou, Xiaohong Zhang, Liqun Zou, Junning Cao, Yuhuan Gao, Chuan Jin, Xiaoling Li, Hui Liu and 9 more

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

Trial report in Cancer immunology, immunotherapy : CII, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03639181 (A Study to Evaluate the Efficacy and Safety of Genormab Injection in Chinese Patients With Recurrent or Refractory B-cell Non-Hodgkin's Lymphoma), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.8field-weighted citation impact, top 27% 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.

NCT03639181 phase2unknown statusnot on this map

A Study to Evaluate the Efficacy and Safety of Genormab Injection in Chinese Patients With Recurrent or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)

TypeinterventionalSponsorGenor Biopharma Co., Ltd.Ran2018 to 2022Enrolled53ConditionsB-cell Non-Hodgkin's LymphomaArmsGB226
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Review
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

19 authors at 15 institutions in 1 country.

Yuankai ShiDepartment of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, No. 17 Panjiayuan Nanli, Chaoyang District, Beijing, 100021, China. syuankai@cicams.ac.cn.ORCID http://orcid.org/0000-0002-3342-4964
Jie CuiDepartment of Hematology, Gansu Provincial Cancer Hospital, Lanzhou, China.
Hui ZhouDepartment of Lymphoma and Hematology, Hunan Cancer Hospital, Changsha, China.
Xiaohong ZhangDepartment of Hematology, The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, China.
Liqun ZouDepartment of Medical Oncology, West China Hospital, Sichuan University, Chengdu, China.
Junning CaoDepartment of Hematology, Fudan University Shanghai Cancer Center, Shanghai, China.
Yuhuan GaoDepartment of Hematology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.
Chuan JinDepartment of Medical Oncology, The Affiliated Cancer Hospital of Guangzhou Medical University, Guangzhou, China.
Xiaoling LiDepartment of Medical Oncology, Liaoning Cancer Hospital and Institute, Shenyang, China.
Hui LiuDepartment of Hematology, Beijing Hospital, Beijing, China.
Zhigang PengDepartment of Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.
Liping XieDepartment of Hematology, West China Hospital, Sichuan University, Chengdu, China.
Huilai ZhangDepartment of Lymphoma, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.
Weihua ZhangDepartment of Hematology, The First Affiliated Hospital of Shanxi Medical University, Taiyuan, China.
Hongyu ZhangDepartment of Oncology, The Fifth Affiliated Hospital Sun Yat-Sen University, Zhuhai, China.
Liye ZhongDepartment of Hematology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.
Fang ZhouDepartment of Hematology, The 960th Hospital of the PLA Joint Logistics Support Force, Tai'an, China.
Genny GuoDepartment of Medical Science, Genor Biopharma Co., Ltd., Shanghai, China.
Wenduo HeDepartment of Medical Science, Genor Biopharma Co., Ltd., Shanghai, China.
Sichuan University · CNSun Yat-sen University · CN82th Hospital of Pla · CNBeijing Hospital · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNFudan University Shanghai Cancer Center · CNGansu Provincial Hospital · CNGuangdong Academy of Medical Sciences · CNGuangxi Medical University · CNGuangzhou Medical University · CNHebei Medical University · CNHunan Cancer Hospital · CNLiaoning Cancer Hospital & Institute · CNSecond Affiliated Hospital of Zhejiang University · CNShanxi Medical University · CN

Funding

China and partly supported by China National Major Project for New Drug Innovation 2017ZX09304015
6 · The paper itself

Abstract

backgroundThis study aimed to assess the efficacy and safety of geptanolimab (GB226), a fully humanized, recombinant anti-programmed cell death-1 monoclonal antibody, in Chinese patients with refractory or relapsed (r/r) primary mediastinal large B-cell lymphoma (PMBCL).

methodsThis was a multicenter, open-label, single-arm phase II study (Gxplore-003), conducted at 43 hospitals in China (NCT03639181). Patients received geptanolimab intravenously at a dose of 3 mg/kg every 2 weeks until documented confirmed disease progression, intolerable toxicity, or any other cessation criteria was met. The primary endpoint was objective response rate (ORR) in the full analysis set assessed by the independent review committee (IRC) according to the Lugano Classification 2014.

resultsThis study was prematurely terminated due to the slow rate of patient accrual. Between Oct 15th, 2018 and Oct 7th, 2020, 25 patients were enrolled and treated. By the data cutoff date on Dec 23rd, 2020, the IRC-assessed ORR was 68.0% (17/25; 95% confidence interval [CI] 46.5-85.1%), with the complete response rate of 24%. The disease control rate was 88% (22/25; 95%CI 68.8-97.5%). Median duration of response was not reached (NR) (95%CI, 5.62 months to NR), with 79.5% of patients having response durations of more than 12 months. Median progression-free survival was NR (95%CI, 6.83 months to NR). Treatment-related adverse events (TRAEs) were reported in 20 of 25 (80.0%) patients, and grade 3 or higher TRAEs occurred in 11 of 25 (44%) patients. No treatment-related deaths occurred. The immune-related adverse events (irAEs) of any grade were observed in 6 (24.0%) patients, and no grade 4 or grade 5 irAEs were reported.

conclusionGeptanolimab (GB226) demonstrated promising efficacy and a manageable safety profile in Chinese patients with r/r PMBCL.

Indexed as

Lymphoma, Large B-Cell, DiffuseThymus NeoplasmsAdultAntibodies, MonoclonalHumansImmune Checkpoint InhibitorsNeoplasm Recurrence, LocalAntibodies, MonoclonalImmune Checkpoint InhibitorsEfficacyGeptanolimab (GB226)Primary mediastinal large B-cell lymphomaRelapsed/refractorySafety

Identifiers

PMID37289256
PMCPMC10992796
OpenAlexW4379769099

What OpenQuestion holds

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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.