Evidence map›Paper›PMID 28168303›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2017

Pembrolizumab as first-line therapy for patients with PD-L1-positive advanced non-small cell lung cancer: a phase 1 trial.

R Hui, E B Garon, J W Goldman, N B Leighl, M D Hellmann, A Patnaik, L Gandhi, J P Eder, M-J Ahn, L Horn and 8 more

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

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01295827 (Phase I Study of Single Agent Pembrolizumab), which is not on this map. Cited by 143 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
143citing papers in PubMed, 14 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.

NCT01295827 phase1completednot on this map

Phase I Study of Single Agent Pembrolizumab (MK-3475) in Patients With Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, and Non-Small Cell Lung Carcinoma (KEYNOTE 001)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2011 to 2018Enrolled1,260ConditionsCancer, Solid TumorArmsPembrolizumab
3 · Its place in the literature

Who cites it

143 citing papers in PubMed, 14 syntheses or guidelines pooled it.

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  17. Efficacy and Safety of Pembrolizumab in Previously Treated Advanced Neuroendocrine Tumors: Results From the Phase II KEYNOTE-158 Study.Clinical cancer research : an official journal of the American Association for Cancer Research · 2020
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  20. Pharmacogenomics in oncology: mutation-targeted therapy and biomarker integration in non-small cell lung cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review

83 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors.

R HuiMedical Oncology, Westmead Hospital and the University of Sydney, Sydney, Australia.
E B GaronHematology/Oncology, David Geffen School of Medicine at UCLA, Santa Monica, USA.
J W GoldmanHematology/Oncology, David Geffen School of Medicine at UCLA, Santa Monica, USA.
N B LeighlDepartment of Medicine, Princess Margaret Cancer Centre, Toronto, Canada.
M D HellmannHematology/Oncology, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, USA.
A PatnaikOncology and Hematology Clinical Research, South Texas Accelerated Research Therapeutics, San Antonio, TX, USA.
L GandhiHematology/Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
J P EderMedical Oncology, Yale University, New Haven, CT, USA.
M-J AhnHematology and Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
L HornThoracic Oncology, Vanderbilt Ingram Cancer Center, Nashville, TN, USA.
E FelipMedical Oncology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.
E CarcerenyMedical Oncology, Catalan Institute of Oncology Badalona, Badalona, Spain.
R RangwalaMedical Oncology, Merck & Co., Inc., Kenilworth, NJ, USA.
G M LubinieckiMedical Oncology, Merck & Co., Inc., Kenilworth, NJ, USA.
J ZhangMedical Oncology, Merck & Co., Inc., Kenilworth, NJ, USA.
K EmancipatorMedical Oncology, Merck & Co., Inc., Kenilworth, NJ, USA.
C RoachCompanion Diagnostics, Dako, an Agilent Technologies Company, Carpinteria, CA, USA.
N A RizviThoracic Oncology, Columbia University, New York, USA.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

Background: Pembrolizumab improved survival as first- and second-line therapy compared with chemotherapy in patients with highly programmed death ligand 1 (PD-L1) expressing advanced non-small cell lung cancer (NSCLC). We report the long-term safety and clinical activity of pembrolizumab as first-line therapy for patients with advanced NSCLC and the correlation between PD-L1 expression and efficacy. Patients and methods: In the open-label phase 1b KEYNOTE-001 trial, treatment-naive patients with advanced NSCLC whose tumors expressed PD-L1 (≥1% staining, assessed using a prototype assay) were randomly assigned to intravenous pembrolizumab 2 or 10 mg/kg every 3 (Q3W) or 2 (Q2W) weeks. Response was assessed per central RECIST v1.1 every 9 weeks in all patients who received ≥1 pembrolizumab dose. Using pre-treatment tumor tissue, a clinical assay quantified the percentage of tumor cells expressing PD-L1 as tumor proportion score (TPS). Results: Between 1 March 2013 and 18 September 2015, 101 patients received pembrolizumab 2 mg/kg Q3W (n = 6), 10 mg/kg Q3W (n = 49), or 10 mg/kg Q2W (n = 46). Of these, 27 (26.7%) had TPS ≥50%, 52 (51.5%) had TPS 1%-49%, and 12 (11.9%) had TPS <1%. The objective response rate (ORR) was 27% (27/101, 95% CI 18-37) and median overall survival was 22.1 months (95% CI 17.1-27.2). In patients with PD-L1 TPS ≥50%, ORR, 12-month PFS, and 12-month OS were higher [14/27 (51.9%; 95% CI 32%-71%), 54%, and 85%, respectively] than the overall population [27/101 (26.7%; 95% CI 18.4%-36.5%), 35%, 71%]. Pembrolizumab was well tolerated, with only 12 (11.9%) patients experiencing grade 3/4 treatment-related adverse events and no treatment-related deaths. Conclusions: Pembrolizumab provides promising long-term OS benefit with a manageable safety profile for PD-L1-expressing treatment-naive advanced NSCLC, with greatest efficacy observed in patients with TPS ≥50%. Clinical trial name and number: KEYNOTE-001 (ClinicalTrials.gov, NCT01295827).

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic AgentsB7-H1 AntigenCarcinoma, Non-Small-Cell LungDisease-Free SurvivalDose-Response Relationship, DrugFemaleHumansKaplan-Meier EstimateLung NeoplasmsMaleMiddle AgedTreatment OutcomeAntibodies, Monoclonal, HumanizedAntineoplastic AgentsB7-H1 AntigenCD274 protein, humanpembrolizumabanti-PD-1immunotherapynon-small cell lung cancerpembrolizumab

Identifiers

PMID28168303
PMCPMC6354672

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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.