Evidence map›Paper›PMID 30717797›Full record

ArticleJournal for immunotherapy of cancer2019

Avelumab (anti-PD-L1) as first-line switch-maintenance or second-line therapy in patients with advanced gastric or gastroesophageal junction cancer: phase 1b results from the JAVELIN Solid Tumor trial.

Hyun Cheol Chung, Hendrik-Tobias Arkenau, Jeeyun Lee, Sun Young Rha, Do-Youn Oh, Lucjan Wyrwicz, Yoon-Koo Kang, Keun-Wook Lee, Jeffrey R Infante, Sung Sook Lee and 11 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal for immunotherapy of cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01772004 (A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Avelumab), which is not on this map. Cited by 55 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 4 pooled it
7.9field-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.

NCT01772004 phase1completednot on this map

A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Avelumab (MSB0010718C) in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications

TypeinterventionalSponsorEMD Serono Research & Development Institute, Inc.Ran2013 to 2019Enrolled1,756ConditionsSolid TumorsArmsAvelumab
3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 4 syntheses or guidelines pooled it, 82 citations in OpenAlex.

  1. Pooled it
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  17. Immune checkpoint inhibitors and cellular immunotherapy for advanced gastric, gastroesophageal cancer: a long pathway.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2023
    Review
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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

21 authors at 20 institutions in 12 countries.

Hyun Cheol ChungYonsei Cancer Center, Yonsei University College of Medicine, Yonsei University Health System, Seoul, 03722, South Korea. unchung8@yuhs.ac.
Hendrik-Tobias ArkenauSarah Cannon Research Institute/University College London, London, UK.
Jeeyun LeeSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Sun Young RhaYonsei Cancer Center, Yonsei University College of Medicine, Yonsei University Health System, Seoul, 03722, South Korea.
Do-Youn OhSeoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.
Lucjan WyrwiczCentrum Onkologii-Instytut im. M. Sklodowskiej Curie, Warszawa, Poland.
Yoon-Koo KangAsan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Keun-Wook LeeSeoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.
Jeffrey R InfanteSarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, USA.
Sung Sook LeeInje University College of Medicine, Busan, South Korea.
Margaret KemenyQueens Cancer Center, Mt Sinai School of Medicine, New York, USA.
Ulrich KeilholzCharité Comprehensive Cancer Center, Charitéplatz 1, Berlin, Germany.
Bohuslav MelicharPalacky University Medical School and Teaching Hospital, I.P. Pavlova 6, Olomouc, Czech Republic.
Alain MitaSamuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, USA.
Ruth PlummerNorthern Centre for Cancer Care and Newcastle University, Freeman Hospital, Newcastle upon Tyne, UK.
Denis SmithMedical Oncology, Bordeaux University Hospital, Bordeaux CEDEX, France.
Arnold B GelbEMD Serono, Inc, Billerica, USA.
Huiling XiongEMD Serono, Inc, Billerica, USA.
Janet HongEMD Serono, Inc, Billerica, USA.
Vikram ChandEMD Serono, Inc, Billerica, USA.
Howard SafranBrown University, Providence, USA.
Ono Pharmaceutical (United States) · USAstraZeneca (Brazil) · BRBordeaux Population Health · FRBrown University · USCentrum Onkologii · PLInje University Busan Paik Hospital · KRMerck Serono (Italy) · ITMount Sinai Hospital · USPalacký University Olomouc · CZSamueli Institute · USSarah Cannon · USSarah Cannon Research Institute · GBSeoul National University · KRSeoul National University Hospital · KRSungkyunkwan University · KRUlsan College · KRU-M Rogel Cancer Center · USUniversity Health System · USUniversity of Newcastle Australia · AUYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe evaluated the antitumor activity and safety of avelumab, a human anti-PD-L1 IgG1 antibody, as first-line switch-maintenance (1 L-mn) or second-line (2 L) treatment in patients with advanced gastric/gastroesophageal cancer (GC/GEJC) previously treated with chemotherapy.

methodsIn a phase 1b expansion cohort, patients without (1 L-mn) or with (2 L) disease progression following first-line chemotherapy for advanced GC/GEJC received avelumab 10 mg/kg intravenously every 2 weeks. Endpoints included best overall response, progression-free survival (PFS), overall survival (OS), and safety.

resultsOverall, 150 patients were enrolled (1 L-mn, n = 90; 2 L, n = 60) and median follow-up in the 1 L-mn and 2 L subgroups was 36.0 and 33.7 months, respectively. The confirmed objective response rate was 6.7% in both subgroups (95% CI, 2.5-13.9% and 1.8-16.2%, respectively), including complete responses in 2.2% of the 1 L-mn subgroup (n = 2). In the 1 L-mn and 2 L subgroups, median duration of response was 21.4 months (95% CI, 4.0-not estimable) and 3.5 months (95% CI, 2.8-8.3) and disease control rates were 56.7 and 28.3%, respectively. Median PFS in the 1 L-mn and 2 L subgroups was 2.8 months (95% CI, 2.3-4.1) and 1.4 months (95% CI, 1.3-1.5), with 6-month PFS rates of 23.0% (95% CI, 14.7-32.4%) and 7.9% (95% CI, 2.6-17.2%), and median OS was 11.1 months (95% CI, 8.9-13.7) and 6.6 months (95% CI, 5.4-9.4), respectively. In the 1 L-mn subgroup, median OS measured from start of 1 L chemotherapy was 18.7 months (95% CI, 15.4-20.6). Across both subgroups, 20.7% had an infusion-related reaction of any grade. Other common treatment-related adverse events (TRAEs) of any grade included fatigue (10.0%) and nausea (6.7%). Treatment-related serious adverse events occurred in 4.0% of patients. Overall, 8.7% had a grade ≥3 TRAE, including 1 treatment-related death.

conclusionAvelumab showed clinical activity and an acceptable safety profile in patients with GC/GEJC.

trial registrationClinicalTrials.gov NCT01772004 ; registered 21 January 2013.

Indexed as

AgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalB7-H1 AntigenEsophageal NeoplasmsEsophagogastric JunctionFemaleHumansImmunoglobulin GKaplan-Meier EstimateMaleMiddle AgedStomach NeoplasmsSurvival AnalysisAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalavelumabB7-H1 AntigenCD274 protein, humanImmunoglobulin GAdenocarcinomaAvelumabEsophagogastric junctionGastricMaintenanceMetastatic

Identifiers

PMID30717797
PMCPMC6362598
OpenAlexW2919913683

What OpenQuestion holds

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LicenceCC BY
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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.