Evidence map›Paper›PMID 27342831›Full record

Trial reportAnnals of surgical oncology2016

Patterns of Clinical Response with Talimogene Laherparepvec (T-VEC) in Patients with Melanoma Treated in the OPTiM Phase III Clinical Trial.

Robert H I Andtbacka, Merrick Ross, Igor Puzanov, Mohammed Milhem, Frances Collichio, Keith A Delman, Thomas Amatruda, Jonathan S Zager, Lee Cranmer, Eddy Hsueh and 3 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Annals of surgical oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03972046 (Neoadjuvant Use of Talimogene Laherparepvec and BRAF/MEK Inhibitor for Advanced Nodal BRAF Mutant Melanoma), which is not on this map. Cited by 179 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
179citing papers in PubMed, 3 pooled it
15.9field-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.

NCT03972046 phase2withdrawnnot on this mapstarted 2019, after this paper: background citation

Neoadjuvant Use of Talimogene Laherparepvec and BRAF/MEK Inhibitor for Advanced Nodal BRAF Mutant Melanoma: A Pilot Study

TypeinterventionalSponsorTriHealth Inc.Ran2019 to 2020Enrolled0ConditionsMelanoma (Skin), Melanoma Stage IIIb-IVM1a, Metastasis Skin, Tumor SkinArmsTalimogene laherparepvec (T-Vec), Dabrafenib (BRAF Inhibitor), Trametinib (MEK Inhibitor)
3 · Its place in the literature

Who cites it

179 citing papers in PubMed, 3 syntheses or guidelines pooled it, 296 citations in OpenAlex.

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  16. Article
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  18. Fully intravenous split-dose administration of the oncolytic adenovirus TILT-123 in advanced solid tumors.Molecular therapy : the journal of the American Society of Gene Therapy · 2026
    Article
  19. Observational
  20. Review

119 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

13 authors at 12 institutions in 1 country.

Robert H I AndtbackaHuntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA. Robert.Andtbacka@hci.utah.edu.
Merrick RossUniversity of Texas MD Anderson Cancer Center, Houston, TX, USA.
Igor PuzanovVanderbilt University Medical Center, Nashville, TN, USA.
Mohammed MilhemUniversity of Iowa Hospitals and Clinics, Iowa City, IA, USA.
Frances CollichioUniversity of North Carolina, Chapel Hill, NC, USA.
Keith A DelmanEmory University, Atlanta, GA, USA.
Thomas AmatrudaMinnesota Oncology, Fridley, MN, USA.
Jonathan S ZagerMoffitt Cancer Center, Tampa, FL, USA.
Lee CranmerUniversity of Washington School of Medicine, Seattle, WA, USA.
Eddy HsuehSaint Louis University Cancer Center, St Louis, MO, USA.
Lisa ChenAmgen Inc., Thousand Oaks, CA, USA.
Mark ShilkrutAmgen Inc., Thousand Oaks, CA, USA.
Howard L KaufmanRutgers Cancer Institute of New Jersey, Rutgers, NJ, USA.
Amgen (United States) · USEmory University · USMinnesota Oncology · USMoffitt Cancer Center · USRutgers Cancer Institute of New JerseySaint Louis University · USThe University of Texas MD Anderson Cancer Center · USUniversity of Iowa Hospitals and Clinics · USUniversity of North Carolina at Chapel Hill · USUniversity of Utah · USUniversity of Washington · USVanderbilt University Medical Center · US

Funding

Viral VectorP30CA086862 · NCI · UNIVERSITY OF IOWA · PI Douglas Robert Spitz · 2000 to 2026
$70.0M
6 · The paper itself

Abstract

purposeTalimogene laherparepvec (T-VEC) is an oncolytic immunotherapy designed to induce tumor regression of injected lesions through direct lytic effects, and of uninjected lesions through induction of systemic antitumor immunity. In this study, we describe the patterns and time course of response to T-VEC from the phase III OPTiM trial of 436 patients with unresected stages IIIB-IV melanoma.

methodsLesion-level response analyses were performed based on the type of lesion (injected or uninjected cutaneous, subcutaneous, or nodal lesions; or visceral lesions [uninjected]), and the best percentage change from baseline of the sum of products of the longest diameters was calculated. Patients randomized to T-VEC (n = 295) who experienced a durable response (continuous partial or complete response for ≥6 months) were evaluated for progression prior to response (PPR), defined as the appearance of a new lesion or >25 % increase in total baseline tumor area.

resultsT-VEC resulted in a decrease in size by ≥50 % in 64 % of injected lesions (N = 2116), 34 % of uninjected non-visceral lesions (N = 981), and 15 % of visceral lesions (N = 177). Complete resolution of lesions occurred in 47 % of injected lesions, 22 % of uninjected non-visceral lesions, and 9 % of visceral lesions. Of 48 patients with durable responses, 23 (48 %) experienced PPR, including 14 who developed new lesions only. No difference in overall survival was observed, and median duration of response was not reached in patients with PPR versus those without PPR.

conclusionsResponses in uninjected lesions provide validation of T-VEC-induced systemic immunotherapeutic effects against melanoma. PPR did not negatively impact the clinical effectiveness of T-VEC.

Indexed as

Oncolytic VirotherapyAdrenal Gland NeoplasmsFemaleGastrointestinal NeoplasmsGranulocyte-Macrophage Colony-Stimulating FactorHerpesvirus 1, HumanHumansInjections, IntralesionalKidney NeoplasmsLiver NeoplasmsLung NeoplasmsLymphatic MetastasisMaleMelanomaPancreatic NeoplasmsSkin NeoplasmsGranulocyte-Macrophage Colony-Stimulating Factor

Identifiers

PMID27342831
PMCPMC5090012
OpenAlexW2473956396

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.