Evidence map›Paper›PMID 31236579›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2019

Safety, efficacy and tumor mutational burden as a biomarker of overall survival benefit in chemo-refractory gastric cancer treated with toripalimab, a PD-1 antibody in phase Ib/II clinical trial NCT02915432.

F Wang, X L Wei, F H Wang, N Xu, L Shen, G H Dai, X L Yuan, Y Chen, S J Yang, J H Shi and 15 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02915432 (A Multi-Center, Open Label Phase Ib/II Clinical Study to Evaluate JS001 in Patients With Advanced Gastric Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Nasopharyngeal Carcinoma and Head and Neck Squamous Cell Carcinoma), which is not on this map. Cited by 312 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
312citing papers in PubMed, 7 pooled it
44.8field-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.

NCT02915432 phase1 / phase2unknown statusnot on this map

A Multi-Center, Open Label Phase Ib/II Clinical Study to Evaluate JS001 in Patients With Advanced Gastric Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Nasopharyngeal Carcinoma and Head and Neck Squamous Cell Carcinoma

TypeinterventionalSponsorShanghai Junshi Bioscience Co., Ltd.Ran2016 to 2022Enrolled401ConditionsGastric Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Nasopharyngeal Carcinoma, Head and Neck Squamous Cell CarcinomaArms3 mg/kg anti-PD-1 mAb JS001 Q2W, 360 mg anti-PD-1 mAb JS001 Q3W, 240mg anti-PD-1 mAb JS001 Q3W
3 · Its place in the literature

Who cites it

312 citing papers in PubMed, 7 syntheses or guidelines pooled it, 471 citations in OpenAlex.

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252 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors at 17 institutions in 1 country.

F WangState Key Laboratory of Oncology in South China, Department of Medical Oncology, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou.
X L WeiState Key Laboratory of Oncology in South China, Department of Medical Oncology, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou.
F H WangState Key Laboratory of Oncology in South China, Department of Medical Oncology, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou.
N XuDepartment of Medical Oncology, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou.
L ShenLaboratory of Carcinogenesis & Translational Research for the Ministry of National Education, Department of GI Oncology, Peking University School of Oncology, Beijing Cancer Hospital & Institute, Beijing.
G H DaiDepartment of Medical Oncology, Chinese PLA General Hospital & Chinese PLA Medical Academy, Beijing.
X L YuanDepartment of Oncology, Tongji Hospital, Huazhong University of Science and Technology, Wuhan.
Y ChenThe State Key Laboratory of Biotherapy, Department of Abdominal Cancer, West China Medical School, Cancer Center, West China Hospital, Sichuan University, Chengdu.
S J YangDepartment of Internal Medicine, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou.
J H ShiDepartment of Medical Oncology, Linyi Cancer Hospital, Linyi.
X C HuDepartment of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai.
X Y LinDepartment of Medical Oncology, Fujian Medical University Union Hospital, Fuzhou.
Q Y ZhangDepartment of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin.
J F FengDepartment of Oncology, Nanjing Medical University Affiliated Cancer Hospital, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, Nanjing.
Y BaDepartment of Gastrointestinal Oncology, Tianjin Cancer Hospital, Tianjin.
Y P LiuDepartment of Medical Oncology, The First Hospital of China Medical University, Shenyang.
W LiDepartment of Medical Oncology, The First Hospital of Jilin University, Changchun.
Y Q ShuDepartment of Oncology, Jiangsu Provincial Hospital, Nanjing.
Y JiangDigestive Medical Oncology, Cancer Hospital of Shantou University Medical College, Shantou.
Q LiDepartment of Medical Oncology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai.
J W WangState Key Laboratory of Oncology in South China, Department of Ultrasonography, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou.
H WuShanghai Junshi Biosciences Co., Ltd, Shanghai, China.
H FengShanghai Junshi Biosciences Co., Ltd, Shanghai, China.
S YaoShanghai Junshi Biosciences Co., Ltd, Shanghai, China.
R H XuState Key Laboratory of Oncology in South China, Department of Medical Oncology, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou. Electronic address: xurh@sysucc.org.cn.
Sun Yat-sen University · CNChinese PLA General Hospital · CNFirst Hospital of China Medical University · CNFujian Medical University · CNHarbin Medical University · CNJiangsu Cancer Hospital · CNJiangsu Provincial Hospital of Traditional Chinese Medicine · CNJilin University · CNPeking University · CNShanghai Jiao Tong University · CNShanghai Medical College of Fudan University · CNShantou University · CNSichuan University · CNTianjin Medical University Cancer Institute and Hospital · CNTongji Hospital · CNZhejiang University · CNZhengzhou University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHigh tumor mutational burden (TMB-H) is correlated with enhanced objective response rate (ORR) and progression-free survival (PFS) for certain cancers receiving immunotherapy. This study aimed to investigate the safety and efficacy of toripalimab, a humanized programmed death-1 (PD-1) antibody, in advanced gastric cancer (AGC), and the predictive survival benefit of TMB and PD-L1. PATIENTS AND

methodsWe reported on the AGC cohort of phase Ib/II trial evaluating the safety and activity of toripalimab in patients with AGC, oesophageal squamous cell carcinoma, nasopharyngeal carcinoma and head and neck squamous cell carcinoma. In cohort 1, 58 chemo-refractory AGC patients received toripalimab (3 mg/kg d1, Q2W) as a monotherapy. In cohort 2, 18 chemotherapy-naive AGC patients received toripalimab (360 mg d1, Q3W) with oxaliplatin 130 mg/m2 qd, d1, capecitabine 1000 mg/m2 b.i.d., d1-d14, Q3W as first-line treatment. Primary end point was ORR. Biomarkers such as PD-L1 and TMB were evaluated for correlation with clinical efficacy.

resultsIn cohort 1, the ORR was 12.1% and the disease control rate (DCR) was 39.7%. Median PFS was 1.9 months and median OS was 4.8 months. The TMB-H group showed significant superior OS than the TMB-L group [14.6 versus 4.0 months, HR = 0.48 (96% CI 0.24-0.96), P = 0.038], while PD-L1 overexpression did not correlate with significant survival benefit. A 77.6% of patients experienced at least one treatment-related adverse event (TRAE), and 22.4% of patients experienced a grade 3 or higher TRAE. In cohort 2, the ORR was 66.7% and the DCR was 88.9%. A 94.4% of patients experienced at least one TRAE and 38.9% of patients experienced grade 3 or higher TRAEs.

conclusionsToripalimab has demonstrated a manageable safety profile and promising antitumor activity in AGC patients, especially in combination with XELOX. High TMB may be a predictive marker for OS of AGC patients receiving toripalimab as a single agent.

trial registrationClinicalTrials.gov NCT02915432.

Indexed as

AdolescentAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalBiomarkers, TumorDisease-Free SurvivalFemaleHumansKaplan-Meier EstimateMaleMiddle AgedMutationProgrammed Cell Death 1 ReceptorStomach NeoplasmsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalBiomarkers, TumorPDCD1 protein, humanProgrammed Cell Death 1 Receptortoripalimabgastric cancerimmunotherapyprogrammed death ligand-1tumor mutational burden

Identifiers

PMID31236579
PMCPMC6771223
OpenAlexW2954094199

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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.