Evidence map›Paper›PMID 30082870›Full record

ArticleNature medicine2018

Blood-based tumor mutational burden as a predictor of clinical benefit in non-small-cell lung cancer patients treated with atezolizumab.

David R Gandara, Sarah M Paul, Marcin Kowanetz, Erica Schleifman, Wei Zou, Yan Li, Achim Rittmeyer, Louis Fehrenbacher, Geoff Otto, Christine Malboeuf and 12 more

3 registry-linked trialsAbstract read
PubMed Publisher
In one paragraph

Article in Nature medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 687 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
687citing papers in PubMed, 5 pooled it
59.9field-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.

NCT04010071 phase2unknown statusnot on this mapstarted 2020, after this paper: background citation

Axitinib Plus Toripalimab as Second-line Treatment in Hepatobiliary Malignant Tumors: a Single-arm, Non-randomized, Single-center Phase II Trial

TypeinterventionalSponsorPeking Union Medical College HospitalRan2020 to 2024Enrolled60ConditionsHepatobiliary Neoplasm, Liver Neoplasm, Biliary Tract NeoplasmsArmsaxitinib plus toripalimab
NCT04059887 phase4completednot on this mapstarted 2019, after this paper: background citation

Evaluation of Blood Tumor Mutation Burden (TMB) for Improved Efficacy of Atezolizumab in 2nd Line Non-small Cell Lung Cancer (NSCLC) [BUDDY]

TypeinterventionalSponsorChonnam National University HospitalRan2019 to 2022Enrolled100ConditionsLung Neoplasm MalignantArmsAtezolizumab Injection [Tecentriq]
NCT04263688 unknown statusnot on this mapstarted 2020, after this paper: background citation

Multicenter Observational Study for Correlation Between Tumor Mutation Burden and Immunotherapy Efficacy of Advanced Non-small Cell Lung Cancer With Malignant Pleural Effusion

TypeobservationalSponsorGuangzhou Institute of Respiratory DiseaseRan2020 to 2022Enrolled300ConditionsNon-Small Cell Lung CancerArmsNon-Intervention
3 · Its place in the literature

Who cites it

687 citing papers in PubMed, 5 syntheses or guidelines pooled it, 1,185 citations in OpenAlex.

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  4. Influence ofJCO precision oncology · 2024
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  6. TAPISTRY: A Phase II Study of Atezolizumab in Patients with Tumor Mutational Burden-High Tumors.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
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627 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 4 institutions in 2 countries.

David R GandaraUC Davis Comprehensive Cancer Center, Sacramento, CA, USA. drgandara@ucdavis.edu.
Sarah M PaulGenentech, Inc., San Francisco, CA, USA.
Marcin KowanetzGenentech, Inc., San Francisco, CA, USA.
Erica SchleifmanGenentech, Inc., San Francisco, CA, USA.
Wei ZouGenentech, Inc., San Francisco, CA, USA.
Yan LiGenentech, Inc., San Francisco, CA, USA.
Achim RittmeyerLungenfachklinik Immenhausen, Immenhausen, Germany.
Louis FehrenbacherKaiser Permanente Medical Center, Vallejo, CA, USA.
Geoff OttoFoundation Medicine, Inc., Cambridge, MA, USA.
Christine MalboeufFoundation Medicine, Inc., Cambridge, MA, USA.
Daniel S LieberFoundation Medicine, Inc., Cambridge, MA, USA.
Doron LipsonFoundation Medicine, Inc., Cambridge, MA, USA.
Jacob SilterraFoundation Medicine, Inc., Cambridge, MA, USA.
Lukas AmlerGenentech, Inc., San Francisco, CA, USA.
Todd RiehlGenentech, Inc., San Francisco, CA, USA.
Craig A CummingsGenentech, Inc., San Francisco, CA, USA.
Priti S HegdeGenentech, Inc., San Francisco, CA, USA.
Alan SandlerGenentech, Inc., San Francisco, CA, USA.
Marcus BallingerGenentech, Inc., San Francisco, CA, USA.
David FabrizioFoundation Medicine, Inc., Cambridge, MA, USA.
Tony MokState Key Laboratory of Southern China, Department of Clinical Oncology, Chinese University of Hong Kong, Hong Kong, China. tony@clo.cuhk.edu.hk.
David S ShamesGenentech, Inc., San Francisco, CA, USA. shames.david@gene.com.
Foundation Medicine (United States)Chinese University of Hong Kong · CNKaiser Permanente Vallejo Medical Center · USUniversity of California, Davis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Although programmed death-ligand 1-programmed death 1 (PD-L1-PD-1) inhibitors are broadly efficacious, improved outcomes have been observed in patients with high PD-L1 expression or high tumor mutational burden (TMB). PD-L1 testing is required for checkpoint inhibitor monotherapy in front-line non-small-cell lung cancer (NSCLC). However, obtaining adequate tumor tissue for molecular testing in patients with advanced disease can be challenging. Thus, an unmet medical need exists for diagnostic approaches that do not require tissue to identify patients who may benefit from immunotherapy. Here, we describe a novel, technically robust, blood-based assay to measure TMB in plasma (bTMB) that is distinct from tissue-based approaches. Using a retrospective analysis of two large randomized trials as test and validation studies, we show that bTMB reproducibly identifies patients who derive clinically significant improvements in progression-free survival from atezolizumab (an anti-PD-L1) in second-line and higher NSCLC. Collectively, our data show that high bTMB is a clinically actionable biomarker for atezolizumab in NSCLC.

Indexed as

Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedB7-H1 AntigenBiomarkers, TumorCarcinoma, Non-Small-Cell LungHumansImmunotherapyKaplan-Meier EstimateLung NeoplasmsMutationProgression-Free SurvivalTreatment OutcomeTumor BurdenAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedatezolizumabB7-H1 AntigenBiomarkers, TumorCD274 protein, human

Identifiers

PMID30082870
OpenAlexW2886963239

What OpenQuestion holds

Textmetadata
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.