Evidence map›Paper›PMID 26981242›Full record

ArticleJournal for immunotherapy of cancer2016

Systemic versus local responses in melanoma patients treated with talimogene laherparepvec from a multi-institutional phase II study.

Howard L Kaufman, Thomas Amatruda, Tony Reid, Rene Gonzalez, John Glaspy, Eric Whitman, Kevin Harrington, John Nemunaitis, Andrew Zloza, Michael Wolf and 1 more

Registry-linked trialAbstract read
In one paragraph

Article in Journal for immunotherapy of cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03792724 (Phase I-II Study of Intratumoral Urelumab Combined With Nivolumab in Patients With Solid Tumors), which is not on this map. Cited by 57 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed, 2 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.

NCT03792724 phase1 / phase2unknown statusnot on this mapstarted 2019, after this paper: background citation

Phase I-II Study of Intratumoral Urelumab Combined With Nivolumab in Patients With Solid Tumors

TypeinterventionalSponsorClinica Universidad de Navarra, Universidad de NavarraRan2019 to 2023Enrolled32ConditionsNeoplasmsArmsUrelumab + Nivolumab
3 · Its place in the literature

Who cites it

57 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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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.

Howard L KaufmanRutgers Cancer Institute of New Jersey, 195 Little Albany Street, Room 2004, New Brunswick, NJ 08901 USA.ORCID 0000-0003-3538-4166
Thomas AmatrudaMinnesota Oncology, Fridley, MN USA.
Tony ReidUniversity of California San Diego Medical Center, La Jolla, CA USA.
Rene GonzalezUniversity of Colorado Cancer Center, Aurora, CO USA.
John GlaspyUCLA Jonsson Comprehesive Cancer Center, Los Angeles, CA USA.
Eric WhitmanCarol G. Simon Cancer Center, Morristown, NJ USA.
Kevin HarringtonThe Institute of Cancer Research/Royal Marsden NIHR Biomedical Research Centre, London, UK.
John NemunaitisMary Crowley Cancer Research Centers, Dallas, TX USA.
Andrew ZlozaRutgers Cancer Institute of New Jersey, 195 Little Albany Street, Room 2004, New Brunswick, NJ 08901 USA.
Michael WolfAmgen Inc., Thousand Oaks, CA USA.
Neil N SenzerMary Crowley Cancer Research Centers, Dallas, TX USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe previously reported that talimogene laherparepvec, an oncolytic herpes virus encoding granulocyte-macrophage colony-stimulating factor (GM-CSF), resulted in an objective response rate of 26 % in patients with advanced melanoma in a phase II clinical trial. The response of individual lesions, however, was not reported. Since talimogene laherparepvec is thought to mediate anti-tumor activity through both direct tumor cytolysis and induction of systemic tumor-specific immunity, we sought to determine the independent response rate in virus-injected and non-injected lesions.

methodsFifty patients with stage IIIC or IV melanoma were treated with talimogene laherparepvec in a multi-institutional single-arm open-label phase II clinical trial. In this study patients were treated until a complete response was achieved, all accessible tumors disappeared, clinically significant disease progression, or unacceptable toxicity. This report is a post hoc analysis of the systemic effects of talimogene laherparepvec in injected lesions and two types of uninjected lesions-non-visceral lesions and visceral lesions.

resultsEleven of 23 patients (47.8 %) had a ≥ 30 % reduction in the total burden of uninjected non-visceral lesions, and 2 of 12 patients (16.7 %) had a ≥ 30 % reduction in the total burden of visceral lesions. Among 128 evaluable lesions directly injected with talimogene laherparepvec, 86 (67.2 %) decreased in size by ≥ 30 % and 59 (46.1 %) completely resolved. Of 146 uninjected non-visceral lesions, 60 (41.1 %) decreased in size by ≥ 30 %, the majority of which (44 [30.1 %]) completely resolved. Of 32 visceral lesions, 4 (12.5 %) decreased in size by ≥ 30 %, and 3 (9.4 %) completely resolved. The median time to lesion response was shortest for lesions that were directly injected (18.4 weeks), followed by uninjected non-visceral lesions (23.1 weeks) and visceral lesions (51.3 weeks), consistent with initiation of a delayed regional and systemic anti-tumor immune response to talimogene laherparepvec.

conclusionsThese results support a regional and systemic effect of talimogene laherparepvec immunotherapy in patients with advanced melanoma.

Indexed as

Herpes virusImmunotherapyMelanomaOncolytic virusTalimogene laherparepvecT-VEC

Identifiers

PMID26981242
PMCPMC4791835

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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.