Evidence map›Paper›PMID 27895500›Full record

ArticleOncoTargets and therapy2016

Efficacy and safety of talimogene laherparepvec versus granulocyte-macrophage colony-stimulating factor in patients with stage IIIB/C and IVM1a melanoma: subanalysis of the Phase III OPTiM trial.

Kevin J Harrington, Robert Hi Andtbacka, Frances Collichio, Gerald Downey, Lisa Chen, Zsolt Szabo, Howard L Kaufman

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in OncoTargets and therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00769704 (A Randomized Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Treatment With OncoVEX^GM-CSF Compared to Subcutaneously Administered GM-CSF in Melanoma Patients With Unresectable Stage IIIb, IIIc and IV Disease), which is not on this map. Cited by 48 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 1 pooled it
6.6field-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.

NCT00769704 phase3completednot on this map

A Randomized Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Treatment With OncoVEX^GM-CSF Compared to Subcutaneously Administered GM-CSF in Melanoma Patients With Unresectable Stage IIIb, IIIc and IV Disease

TypeinterventionalSponsorBioVex LimitedRan2009 to 2014Enrolled437ConditionsMelanomaArmsTalimogene laherparepvec, GM-CSF
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 1 synthesis or guideline pooled it, 99 citations in OpenAlex.

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  14. Advances in the clinical development of oncolytic viruses.American journal of translational research · 2022
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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

7 authors at 6 institutions in 3 countries.

Kevin J HarringtonThe Institute of Cancer Research/The Royal Marsden Hospital NIHR Biomedical Research Centre, London, UK.
Robert Hi AndtbackaHuntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.
Frances CollichioDivision of Hematology and Oncology, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Gerald DowneyAmgen Ltd, Cambridge, UK.
Lisa ChenAmgen Inc, Thousand Oaks, CA, USA.
Zsolt SzaboAmgen GmbH, Zug, Switzerland.
Howard L KaufmanRutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.
Amgen (Switzerland) · CHAmgen (United Kingdom) · GBRoyal Marsden Hospital · GBRutgers Cancer Institute of New JerseyUniversity of North Carolina at Chapel Hill · USUniversity of Utah · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTalimogene laherparepvec is the first oncolytic immunotherapy to receive approval in Europe, the USA and Australia. In the randomized, open-label Phase III OPTiM trial (NCT00769704), talimogene laherparepvec significantly improved durable response rate (DRR) versus granulocyte-macrophage colony-stimulating factor (GM-CSF) in 436 patients with unresectable stage IIIB-IVM1c melanoma. The median overall survival (OS) was longer versus GM-CSF in patients with earlier-stage melanoma (IIIB-IVM1a). Here, we report a detailed subgroup analysis of the OPTiM study in patients with IIIB-IVM1a disease. PATIENTS AND

methodsThe patients were randomized (2:1 ratio) to intralesional talimogene laherparepvec or subcutaneous GM-CSF and were evaluated for DRR, overall response rate (ORR), OS, safety, benefit-risk and numbers needed to treat. Descriptive statistics were used for subgroup comparisons.

resultsAmong 249 evaluated patients with stage IIIB-IVM1a melanoma, DRR was higher with talimogene laherparepvec compared with GM-CSF (25.2% versus 1.2%;

conclusionThe subgroup of patients with stage IIIB, IIIC and IVM1a melanoma (57.1% of the OPTiM intent-to-treat population) derived greater benefit in DRR and ORR from talimogene laherparepvec compared with GM-CSF. Talimogene laherparepvec was well tolerated.

Indexed as

benefit–riskclinical trialdurable response rateimmunotherapyoncolytic virustalimogene laherparepvec

Identifiers

PMID27895500
PMCPMC5119624
OpenAlexW2555619826

What OpenQuestion holds

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LicenceCC BY-NC
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.