Evidence map›Paper›PMID 31413923›Full record

ArticleOncoimmunology

Vaccinia-based oncolytic immunotherapy Pexastimogene Devacirepvec in patients with advanced hepatocellular carcinoma after sorafenib failure: a randomized multicenter Phase IIb trial (TRAVERSE).

M Moehler, J Heo, H C Lee, W Y Tak, Y Chao, S W Paik, H J Yim, K S Byun, A Baron, G Ungerechts and 27 more

Open access · goldAbstract read
In one paragraph

Article in Oncoimmunology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 89 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
89citing papers in PubMed, 3 pooled it
12.5field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

89 citing papers in PubMed, 3 syntheses or guidelines pooled it, 127 citations in OpenAlex.

  1. Pooled it
  2. Gene therapy for people with hepatocellular carcinoma.The Cochrane database of systematic reviews · 2024
    Pooled it
  3. Pooled it
  4. Review
  5. Article
  6. Review
  7. Review
  8. Oncolytic viruses: advanced strategies in cancer therapy.Signal transduction and targeted therapy · 2026
    Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. Review
  14. Review
  15. Article
  16. Article
  17. Advancements in second-line treatment research for hepatocellular carcinoma.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
    Review
  18. Review
  19. Article
  20. Cancer vaccines: current status and future directions.Journal of hematology & oncology · 2025
    Review

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

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

37 authors at 20 institutions in 6 countries.

M MoehlerFirst Department of Medicine, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.
J HeoCollege of Medicine, Pusan National University and Medical Research Institute, Pusan National University Hospital, Busan, Republic of Korea.ORCID 0000-0003-0961-7851
H C LeeAsan Medical Center, University of Ulsan College of Medicine, Ulsan, Republic ofKorea.
W Y TakSchool of Medicine, Kyungpook National University Medical Center, Daegu, Republic of Korea.ORCID 0000-0002-1914-5141
Y ChaoDepartment of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan.
S W PaikDepartment of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
H J YimDepartment of Internal Medicine, Korea University Ansan Hospital, Ansan-si, Republic of Korea.ORCID 0000-0002-6036-2754
K S ByunDepartment of Internal Medicine, Korea UniversityCollege of Medicine, Seoul, Republic of Korea.
A BaronDepartment of Medicine, California Pacific Medical Center, San Francisco, CA, USA.
G UngerechtsDepartment of Medical Oncology, National Center for Tumor Diseases (NCT) and Heidelberg University Hospital, Heidelberg, Germany.
D JonkerThe Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Canada.
L RuoDepartment of Surgery, Juravinski Hospital and Cancer Centre, McMaster University, Hamilton, Canada.
M ChoDepartment of Internal Medicine, Pusan National University Yangsan Hospital, Busan, Republic of Korea.
A KaubischDepartment of Medicine, Montefiore Medical Center, New York, NY, USA.
H WegeDepartment of Medicine, Gastroenterology and Hepatology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
P MerleHepatology Unit, Croix-Rousse Hospital, Lyon, France.
O EbertKlinik und Poliklinik für Innere Medizin II, Klinikum rechts der Isar, Technical University, Munich, Germany.
F HabersetzerPôle Hépato-Digestif, Hôpitaux Universitaires de Strasbourg, INSERM 1110, IHU de Strasbourg and Université de Strasbourg, Strasbourg, France.
J F BlancHepato-Gastroenterology and Digestive Oncology Department, CHU Bordeaux, Bordeaux, France.
Olivier RosmorducSorbonne Université, AP-HP, Hôpital Paul Brousse, Villejuif, France.
R LencioniSylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, FL, USA.
R PattRad-MD, New York, NY, USA.
A M LeenDepartment of Pediatrics, Baylor College of Medicine, Houston, TX, USA.
F FoersterFirst Department of Medicine, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.ORCID 0000-0002-3234-8891
M HomerinMedical Affairs, Transgene S.A., Illkirch-Graffenstaden, France.
N StojkowitzClinical Operations, Transgene S.A., 400 Bd Gonthier d'Andernach, Parc d'Innovation, 67405 Illkirch-Graffenstaden, France.
M LuskyProgram Management, Transgene S.A., 400 Bd Gonthier d'Andernach, Parc d'Innovation, 67405 Illkirch-Graffenstaden, France.
J M LimacherMedical Affairs, Transgene S.A., 400 Bd Gonthier d'Andernach, Parc d'Innovation, 67405 Illkirch-Graffenstaden, France.
M HennequiBiostatistics, Transgene S.A., 400 Bd Gonthier d'Andernach, Parc d'Innovation, 67405 Illkirch-Graffenstaden, France.
N GasparClinical Assays, SillaJen Inc., San Francisco, CA, USA.
B McFaddenAnalytical Development and Quality Control, SillaJen Inc., San Francisco, CA, USA.
N De SilvaClinical, SillaJen Inc., San Francisco, CA, USA.
D ShenClinical, SillaJen Inc., San Francisco, CA, USA.
A PelusioClinical, SillaJen Inc., San Francisco, CA, USA.
D H KirnSillaJen Inc., San Francisco, CA, USA.
C J BreitbachClinical, SillaJen Inc., San Francisco, CA, USA.
J M BurkeClinical, SillaJen Inc., San Francisco, CA, USA.
SillaJen (United States) · USTransgene (France) · FRJohannes Gutenberg University Mainz · DEKorea University · KRBaylor College of Medicine · USCalifornia Pacific Medical Center · USCentre Hospitalier Universitaire de Bordeaux · FRHeidelberg University · DEHôpital de la Croix-Rousse · FRInserm · FRJuravinski Hospital · CAKyungpook National University Medical Center · KRMontefiore Medical Center · USPusan National University Hospital · KRPusan National University Yangsan Hospital · KRSamsung Medical Center · KRSorbonne Université · FRTaipei Veterans General Hospital · TWTUM Klinikum · DEUlsan College · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Pexastimogene devacirepvec (Pexa-Vec) is a vaccinia virus-based oncolytic immunotherapy designed to preferentially replicate in and destroy tumor cells while stimulating anti-tumor immunity by expressing GM-CSF. An earlier randomized Phase IIa trial in predominantly sorafenib-naïve hepatocellular carcinoma (HCC) demonstrated an overall survival (OS) benefit. This randomized, open-label Phase IIb trial investigated whether Pexa-Vec plus Best Supportive Care (BSC) improved OS over BSC alone in HCC patients who failed sorafenib therapy (TRAVERSE). 129 patients were randomly assigned 2:1 to Pexa-Vec plus BSC vs. BSC alone. Pexa-Vec was given as a single intravenous (IV) infusion followed by up to 5 IT injections. The primary endpoint was OS. Secondary endpoints included overall response rate (RR), time to progression (TTP) and safety. A high drop-out rate in the control arm (63%) confounded assessment of response-based endpoints. Median OS (ITT) for Pexa-Vec plus BSC vs. BSC alone was 4.2 and 4.4 months, respectively (HR, 1.19, 95% CI: 0.78-1.80; p = .428). There was no difference between the two treatment arms in RR or TTP. Pexa-Vec was generally well-tolerated. The most frequent Grade 3 included pyrexia (8%) and hypotension (8%). Induction of immune responses to vaccinia antigens and HCC associated antigens were observed. Despite a tolerable safety profile and induction of T cell responses, Pexa-Vec did not improve OS as second-line therapy after sorafenib failure. The true potential of oncolytic viruses may lie in the treatment of patients with earlier disease stages which should be addressed in future studies.

Indexed as

Hepatocellular carcinomaoncolytic immunotherapyoncolytic vacciniaPexa-Vecsorafenib

Identifiers

PMID31413923
PMCPMC6682346
OpenAlexW2948320538

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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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.