Evidence map›Paper›PMID 31409575›Full record

Trial reportEBioMedicine2019

Biodistribution, shedding, and transmissibility of the oncolytic virus talimogene laherparepvec in patients with melanoma.

Robert H I Andtbacka, Thomas Amatruda, John Nemunaitis, Jonathan S Zager, John Walker, Jason A Chesney, Kate Liu, Cheng-Pang Hsu, Cheryl A Pickett, Janice M Mehnert

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in EBioMedicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02014441 (A Phase 2, Multicenter, Single-arm Trial to Evaluate the Biodistribution and Shedding of Talimogene Laherparepvec in Subjects With Unresected, Stage IIIB to IVM1c Melanoma), which is not on this map. Cited by 43 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT02014441 phase2completednot on this map

A Phase 2, Multicenter, Single-arm Trial to Evaluate the Biodistribution and Shedding of Talimogene Laherparepvec in Subjects With Unresected, Stage IIIB to IVM1c Melanoma

TypeinterventionalSponsorAmgenRan2014 to 2018Enrolled61ConditionsMelanomaArmsTalimogene laherparepvec
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Robert H I AndtbackaUniversity of Utah Huntsman Cancer Institute, Salt Lake City, UT, USA.
Thomas AmatrudaMinnesota Oncology and Virginia Piper Cancer Institute, Fridley, MN, USA. Electronic address: thomas.amatruda@usoncology.com.
John NemunaitisCollege of Medicine and Life Sciences, The University of Toledo, Toledo, OH, USA.
Jonathan S ZagerMoffitt Cancer Center, 10920 N. McKinley Drive, Tampa, FL 33612, USA.
John WalkerUniversity of Alberta, Edmonton, AB, Canada.
Jason A ChesneyJames Graham Brown Cancer Center, University of Louisville, 529 South Jackson Street, Louisville, KY 40205, USA.
Kate LiuAmgen Inc., One Amgen Center Drive, Thousand Oaks, CA, USA.
Cheng-Pang HsuAmgen Inc., One Amgen Center Drive, Thousand Oaks, CA, USA.
Cheryl A PickettAmgen Inc., One Amgen Center Drive, Thousand Oaks, CA, USA. Electronic address: cpickett@amgen.com.
Janice M MehnertRutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTalimogene laherparepvec (T-VEC) is an intralesionally delivered, modified herpes simplex virus type-1 oncolytic immunotherapy. The biodistribution, shedding, and potential transmission of T-VEC was systematically evaluated during and after completion of therapy in adults with advanced melanoma.

methodsIn this phase 2, single-arm, open-label study, T-VEC was administered into injectable lesions initially at 10

findingsSixty patients received ≥1 dose of T-VEC. During cycles 1-4, T-VEC DNA was detected in blood (98·3% of patients, 36·7% of samples), urine (31·7% of patients, 3·0% of samples) and swabs from injected lesions (100% of patients, 57·6% of samples), exterior of dressings (80% of patients,19·5% of samples), oral mucosa (8·3% of patients, 2·5% of samples), and anogenital area (8·0% of patients, 1·1% of samples). During the safety follow-up period, T-VEC DNA was only detected on swabs from injected lesions (14% of patients, 5.8% of samples). T-VEC DNA was detected in 4/37 swabs (3/19 patients) of suspected herpetic lesions. Among all samples, only those from the surface of injected lesions tested positive for infectivity (8/740 [1·1%]). Three close contacts reported signs and symptoms of suspected herpetic origin; however, no lesions had detectable T-VEC DNA.

interpretationUsing current guidelines, T-VEC can be administered safely to patients with advanced melanoma and is unlikely to be transmitted to close contacts with appropriate use of occlusive dressings. FUND: This study was funded by Amgen Inc.: ClinicalTrials.gov, NCT02014441.

Indexed as

Oncolytic VirotherapyOncolytic VirusesAdultAgedAged, 80 and overBiological ProductsDNA, ViralDrug Administration ScheduleHerpesvirus 1, HumanHumansMelanomaMiddle AgedMultimodal ImagingNeoplasm StagingTissue DistributionTreatment OutcomeBiological ProductsDNA, Viraltalimogene laherparepvecBiodistributionMelanomaOncolytic immunotherapySheddingTalimogene laherparepvecTransmissionT-VEC

Identifiers

PMID31409575
PMCPMC6796514

What OpenQuestion holds

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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.