Evidence map›Paper›PMID 36863095›Full record

ArticleESMO open2023

Phase Ib study of talimogene laherparepvec in combination with atezolizumab in patients with triple negative breast cancer and colorectal cancer with liver metastases.

J R Hecht, S S Raman, A Chan, K Kalinsky, J-F Baurain, M M Jimenez, M M Garcia, M D Berger, U M Lauer, A Khattak and 8 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in ESMO open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03256344 (A Phase 1b Study of Talimogene Laherparepvec in Combination With Atezolizumab in Subjects With Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases), which is not on this map. Cited by 28 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 3 pooled it
7.6field-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.

NCT03256344 phase1completednot on this map

A Phase 1b Study of Talimogene Laherparepvec in Combination With Atezolizumab in Subjects With Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases

TypeinterventionalSponsorAmgenRan2018 to 2021Enrolled36ConditionsMetastatic Triple Negative Breast Cancer, Metastatic Colorectal CancerArmsTalimogene Laherparepvec, Atezolizumab
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 3 syntheses or guidelines pooled it, 33 citations in OpenAlex.

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  17. Immunotherapy in Breast Cancer: Beyond Immune Checkpoint Inhibitors.International journal of molecular sciences · 2025
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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

18 authors at 14 institutions in 6 countries.

J R HechtDivision of Hematology/Oncology, David Geffen School of Medicine at UCLA, Santa Monica, USA. Electronic address: jrhecht@mednet.ucla.edu.
S S RamanDepartment of Radiology, David Geffen School of Medicine at UCLA, Santa Monica, USA.
A ChanBreast Cancer Research Centre - WA & Curtin University, Perth Breast Cancer Institute Hollywood Consulting Centre, Nedlands, Australia.
K KalinskyEmory Winship Cancer Institute, Atlanta, USA.
J-F BaurainCliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium.
M M JimenezHospital General Universitario Gregorio Marañon, Universidad Complutense, CIBERONC, Madrid, Spain.
M M GarciaDepartment of Medical Oncology, Hospital del Mar, CIOCC Barcelona, CIBERONC, Barcelona, Spain.
M D BergerDepartment of Medical Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
U M LauerDepartment of Medical Oncology and Pneumology, Virotherapy Center Tübingen, University Hospital Tübingen, Tübingen, Germany; German Cancer Consortium (DKTK), German Cancer Research Center (DKFZ), partner site Tübingen, Tübingen, Germany.
A KhattakFiona Stanley Hospital & Edith Cowan University, Perth, Australia.
A CarratoMedical Oncology Department, Ramon y Cajal University Hospital, Alcala University, IRYCIS, CIBERONC, Madrid, Spain; Pancreatic Cancer Europe Chairman, Brussels, Belgium.
Y ZhangVirginia Oncology Associates, Norfolk, USA.
K LiuAmgen Inc., Thousand Oaks, USA.
E ChaGenentech, South San Francisco, USA.
A KeeganAmgen Inc., Thousand Oaks, USA.
S BhattaAmgen Inc., Thousand Oaks, USA.
C P StrassburgDepartment of Medicine I, University Hospital Bonn, Medical Clinic and Polyclinic I, Bonn, Germany.
A RoohullahLiverpool Hospital, Liverpool, Australia.
Amgen (United States) · USBreast Cancer Research Foundation · USCentro de Investigación Biomédica en Red de Cáncer · ESCliniques Universitaires Saint-Luc · BEEdith Cowan University · AUEmory Healthcare · USGerman Cancer Research Center · DEHospital General Universitario Gregorio Marañón · ESInstituto Cajal · ESLiverpool Hospital · AUUCLA Health · USUniversity Hospital Bonn · DEUniversity of Bern · CHVirginia Oncology Associates · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTalimogene laherparepvec (T-VEC), a first-in-class oncolytic viral immunotherapy, enhances tumor-specific immune activation. T-VEC combined with atezolizumab, which blocks inhibitor T-cell checkpoints, could provide greater benefit than either agent alone. Safety/efficacy of the combination was explored in patients with triple negative breast cancer (TNBC) or colorectal cancer (CRC) with liver metastases.

methodsIn this phase Ib, multicenter, open-label, parallel cohort study of adults with TNBC or CRC with liver metastases, T-VEC (10

resultsBetween 19 March 2018 and 6 November 2020, 11 patients with TNBC were enrolled (safety analysis set: n = 10); between 19 March 2018 and 16 October 2019, 25 patients with CRC were enrolled (safety analysis set: n = 24). For the 5 patients in the TNBC DLT analysis set, no patient had DLT; for the 18 patients in the CRC DLT analysis set, 3 (17%) had DLT, all serious AEs. AEs were reported by 9 (90%) TNBC and 23 (96%) CRC patients, the majority with grade ≥3 [TNBC, 7 (70%); CRC, 13 (54%)], and 1 was fatal [CRC, 1 (4%)]. Evidence of efficacy was limited. Overall response rate was 10% (95% confidence interval 0.3-44.5) for TNBC; one (10%) patient had a partial response. For CRC, no patients had a response; 14 (58%) were unassessable.

conclusionsThe safety profile reflected known risks with T-VEC including risks of intrahepatic injection; no unexpected safety findings from addition of atezolizumab to T-VEC were observed. Limited evidence of antitumor activity was observed.

Indexed as

Colorectal NeoplasmsLiver NeoplasmsMelanomaOncolytic VirotherapyTriple Negative Breast NeoplasmsAdultAntibodies, Monoclonal, HumanizedBiological ProductsCohort StudiesHerpesvirus 1, HumanHumansAntibodies, Monoclonal, HumanizedatezolizumabBiological Productstalimogene laherparepvecbreast neoplasmsdrug therapy combinationgastrointestinal neoplasmsviral immunotherapyvirotherapy

Identifiers

PMID36863095
PMCPMC10163149
OpenAlexW4322632254

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.