Evidence map›Paper›PMID 33785610›Full record

Trial reportJournal for immunotherapy of cancer2021

Talimogene laherparepvec upregulates immune-cell populations in non-injected lesions: findings from a phase II, multicenter, open-label study in patients with stage IIIB-IVM1c melanoma.

Josep Malvehy, Igor Samoylenko, Dirk Schadendorf, Ralf Gutzmer, Jean-Jacques Grob, Joseph J Sacco, Kevin S Gorski, Abraham Anderson, Cheryl A Pickett, Kate Liu and 1 more

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

Trial report in Journal for immunotherapy of cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02366195 (A Phase 2, Multicenter, Open-label, Single-arm Trial to Evaluate the Correlation Between Objective Response Rate and Baseline Intratumoral CD8+ Cell Density in Subjects With Unresected Stage IIIB to IVM1c Melanoma Treated With Talimogene Laherparepvec), which is not on this map. Cited by 49 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 1 pooled it
10.0field-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.

NCT02366195 phase2completednot on this map

A Phase 2, Multicenter, Open-label, Single-arm Trial to Evaluate the Correlation Between Objective Response Rate and Baseline Intratumoral CD8+ Cell Density in Subjects With Unresected Stage IIIB to IVM1c Melanoma Treated With Talimogene Laherparepvec

TypeinterventionalSponsorAmgenRan2015 to 2020Enrolled112ConditionsUnresected Stage IIIb to IVM1c MelanomaArmsTalimogene Laherparepvec
3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 1 synthesis or guideline pooled it, 74 citations in OpenAlex.

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  13. Next-Generation Oncolytic Viruses to Overcome Resistance to Anti-PD-1 Therapy in Melanoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
    Article
  14. Review
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  16. Oncolytic viruses as cancer therapeutics: From mechanistic insights to clinical translation.Molecular therapy : the journal of the American Society of Gene Therapy · 2025
    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

11 authors at 8 institutions in 7 countries.

Josep MalvehyDermatology Department and IDIBAPS, Hospital Clinic of Barcelona, Barcelona, Catalunya, Spain JMALVEHY@clinic.cat.ORCID 0000-0002-6998-914X
Igor SamoylenkoNN Blokhin Russian Cancer Research Center, Moscow, Russian Federation.
Dirk SchadendorfDepartment of Dermatology, University of Duisburg-Essen, Essen, Germany.
Ralf GutzmerDepartment of Dermatology and Allergy, Skin Cancer Center Hannover, Hannover Medical School, Hannover, Germany.
Jean-Jacques GrobAix-Marseille University and APHM Timone, Marseille, France.
Joseph J SaccoClatterbridge Cancer Centre NHS Foundation Trust, Bebington, Wirral, UK.
Kevin S GorskiAmgen Inc, San Francisco, California, USA.
Abraham AndersonAmgen Inc, Thousand Oaks, California, USA.
Cheryl A PickettAmgen Inc, Thousand Oaks, California, USA.
Kate LiuAmgen Inc, Thousand Oaks, California, USA.
Helen GogasFirst Department of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Amgen (United States) · USAix-Marseille Université · FRGerman Cancer Research Center · DEHospital Clínic de Barcelona · ESMedizinische Hochschule Hannover · DENational and Kapodistrian University of Athens · GRRussian Cancer Research Center NN Blokhin · RUUniversity of Liverpool · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTalimogene laherparepvec (T-VEC), an oncolytic virus, was designed to selectively replicate in and lyse tumor cells, releasing tumor-derived antigen to stimulate a tumor-specific immune response.

methodsIn this phase II study in patients with unresectable stage IIIB-IV melanoma, we evaluated non-injected lesions to establish whether baseline or change in intratumoral CD8

resultsOf 112 enrolled patients, 111 received ≥1 dose of T-VEC. After a median follow-up of 108.0 weeks, objective/complete response rates were 28%/14% in the overall population and 32%/18% in patients with stage IIIB-IVM1a disease. No unexpected toxicity occurred. Baseline and week 6 change from baseline CD8

conclusionsThis study indicates that T-VEC induces systemic immune activity and alters the tumor microenvironment in a way that will likely enhance the effects of other immunotherapy agents in combination therapy. TRIAL REGISTRATION NUMBER: NCT02366195.

Indexed as

Oncolytic VirotherapyAdultAgedAged, 80 and overBiological ProductsCD8-Positive T-LymphocytesEuropeFemaleHerpesvirus 1, HumanHumansLymphocytes, Tumor-InfiltratingMaleMelanomaMiddle AgedNeoplasm StagingOncolytic VirusesBiological Productstalimogene laherparepvecbiomarkersimmunotherapymelanomaoncolytic virotherapyT-lymphocytestumor

Identifiers

PMID33785610
PMCPMC8011715
OpenAlexW3144959724

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.