Evidence map›Paper›PMID 33436023›Full record

Trial reportJournal of hematology & oncology2021

Efficacy and safety of geptanolimab (GB226) for relapsed or refractory peripheral T cell lymphoma: an open-label phase 2 study (Gxplore-002).

Yuankai Shi, Jianqiu Wu, Zhen Wang, Liling Zhang, Zhao Wang, Mingzhi Zhang, Hong Cen, Zhigang Peng, Yufu Li, Lei Fan and 26 more

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

Trial report in Journal of hematology & oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03502629 (A Phase II Clinical Study to Evaluate the Efficacy and Safety of GB226 for the Treatment of Chinese Population With Relapsed and Refractory Peripheral T Cell Lymphoma), which is not on this map. Cited by 45 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 2 pooled it
8.2field-weighted citation impact, top 2% 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.

NCT03502629 phase2unknown statusnot on this map

A Phase II Clinical Study to Evaluate the Efficacy and Safety of GB226 for the Treatment of Chinese Population With Relapsed and Refractory Peripheral T Cell Lymphoma (PTCL)

TypeinterventionalSponsorGenor Biopharma Co., Ltd.Ran2018 to 2022Enrolled86ConditionsPeripheral T Cell LymphomaArmsGB226
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 2 syntheses or guidelines pooled it, 62 citations in OpenAlex.

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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

36 authors at 20 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, Beijing, China. syuankai@cicams.ac.cn.ORCID 0000-0002-8685-6744
Jianqiu WuDepartment of Oncology, Jiangsu Cancer Hospital, Nanjing, China.
Zhen WangDepartment of Oncology, Linyi Cancer Hospital, Linyi, China.
Liling ZhangDepartment of Lymphoma, Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Zhao WangDepartment of Hematology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
Mingzhi ZhangDepartment of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Hong CenDepartment of Hematology, Lymphoma and Pediatric Oncology, Guangxi Medical University Affiliated Tumor Hospital and Oncology Medical College, Nanning, China.
Zhigang PengDepartment of Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China.
Yufu LiDepartment of Hematology, Henan Cancer Hospital, Zhengzhou, China.
Lei FanDepartment of Hematology, Jiangsu Province Hospital, Nanjing, China.
Ye GuoDepartment of Oncology, Shanghai East Hospital, Shanghai, China.
Liping MaDepartment of Hematology, Sun Yat-Sen Memorial Hospital Sun Yat-Sen University, Guangzhou, China.
Jie CuiDepartment of Hematology, Gansu Provincial Cancer Hospital, Lanzhou, China.
Yuhuan GaoDepartment of Hematology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.
Haiyan YangDepartment of Lymphoma, Zhejiang Cancer Hospital, Hangzhou, China.
Hongyu ZhangDepartment of Oncology, The Fifth Affiliated Hospital Sun Yat-Sen University, Zhuhai, China.
Lin WangDepartment of Oncology, Hainan General Hospital, Haikou, China.
Weihua ZhangDepartment of Hematology, The First Affiliated Hospital of Shanxi Medical University, Taiyuan, China.
Huilai ZhangDepartment of Lymphoma, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.
Liping XieDepartment of Hematology, West China Hospital, Sichuan University, Chengdu, China.
Ming JiangDepartment of Oncology, West China Hospital, Sichuan University, Chengdu, China.
Hui ZhouDepartment of Lymphoma and Hematology, Hunan Cancer Hospital, Changsha, China.
Yuerong ShuangDepartment of Lymphoma Hematology and Oncology, Jiangxi Cancer Hospital, Nanchang, China.
Hang SuDepartment of Lymphoma, The Fifth Medical Center of PLA General Hospital, Beijing, China.
Xiaoyan KeDepartment of Hematology, Peking University Third Hospital, Beijing, China.
Chuan JinDepartment of Internal Medicine Section 4, Cancer Center of Guangzhou Medical University, Guangzhou, China.
Xin DuDepartment of Hematology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.
Xin DuDepartment of Hematology, Shenzhen Second People's Hospital, Shenzhen, China.
Li LiuDepartment of Hematology, Tangdu Hospital of the Fourth Military Medical University, Xi'an, China.
Yaming XiDepartment of Hematology, The First Hospital of Lanzhou University, Lanzhou, China.
Zheng GeDepartment of Hematology, Zhongda Hospital Southeast University, Nanjing, China.
Ru FengDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Yang ZhangDepartment of Oncology, The Second Hospital of Dalian Medical University, Dalian, China.
Shengyu ZhouDepartment 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, Beijing, China.
Fan XieDepartment of Medical Science, Genor Biopharma Co., Ltd., Shanghai, China.
Qian WangDepartment of Medical Science, Genor Biopharma Co., Ltd., Shanghai, China.
Sun Yat-sen University · CNCapital Medical University · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNGuangdong Academy of Medical Sciences · CNSichuan University · CNAir Force Medical University · CNChinese PLA General Hospital · CNDalian Medical University · CNFirst Affiliated Hospital of Zhengzhou University · CNFirst Hospital of Lanzhou University · CNGansu Provincial Hospital · CNGuangxi Medical University · CNGuangzhou Medical University · CNHainan General Hospital · CNHebei Medical University · CNHenan Cancer Hospital · CNHunan Cancer Hospital · CNJiangsu Cancer Hospital · CNJiangsu Province Hospital · CNJiangxi Provincial Cancer Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPeripheral T cell lymphoma (PTCL) is a rare disease and recent approved drugs for relapsed/refractory (r/r) PTCL provided limited clinical benefit. We conducted this study to evaluate the efficacy and safety of geptanolimab (GB226), an anti-PD-1 antibody, in r/r PTCL patients.

methodsWe did this single-arm, multicenter phase 2 study across 41 sites in China. Eligible patients with r/r PTCL received geptanolimab 3 mg/kg intravenously every 2 weeks until disease progression or intolerable toxicity. All patients who received at least one dose of geptanolimab and histological confirmed PTCL entered full analysis set (FAS). The primary endpoint was objective response rate (ORR) in FAS assessed by the independent radiological review committee (IRRC) per Lugano 2014 criteria.

resultsBetween July 12, 2018, and August 15, 2019, 102 patients were enrolled and received at least one dose of geptanolimab. At the data cutoff date (August 15, 2020), the median follow-up was 4.06 (range 0.30-22.9) months. For 89 patients in FAS, 36 achieved objective response (40.4%, 95% CI 30.2-51.4), of which 13 (14.6%) were complete response and 23 (25.8%) had partial response assessed by IRRC. The median duration of response (DOR) was 11.4 (95% CI 4.8 to not reached) months per IRRC. Patients with PD-L1 expression ≥ 50% derived more benefit from geptanolimab treatment compared to < 50% ones (ORR, 53.3% vs. 25.0%, p = 0.013; median PFS 6.2 vs. 1.5 months, p = 0.002). Grade ≥ 3 treatment-related adverse events occurred in 26 (25.5%) patients, and the most commonly observed were lymphocyte count decreased (n = 4) and platelet count decreased (n = 3). Serious adverse events were observed in 45 (44.1%) patients and 19 (18.6%) were treatment related.

conclusionsIn this study, geptanolimab showed promising activity and manageable safety profile in patients with r/r PTCL. Anti-PD-1 antibody could be a new treatment approach for this patient population.

trial registrationThis clinical trial was registered at the ClinicalTrials.gov (NCT03502629) on April 18, 2018.

Indexed as

AgedAntineoplastic Agents, ImmunologicalFemaleHumansImmune Checkpoint InhibitorsKaplan-Meier EstimateLymphoma, T-Cell, PeripheralMaleMiddle AgedNeoplasm Recurrence, LocalTreatment OutcomeAntineoplastic Agents, ImmunologicalImmune Checkpoint InhibitorsImmunotherapyPD-1 inhibitorT cell lymphomas

Identifiers

PMID33436023
PMCPMC7802130
OpenAlexW3119864355

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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.