Evidence map›Paper›PMID 31154919›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2019

Five-Year Overall Survival for Patients With Advanced Non‒Small-Cell Lung Cancer Treated With Pembrolizumab: Results From the Phase I KEYNOTE-001 Study.

Edward B Garon, Matthew D Hellmann, Naiyer A Rizvi, Enric Carcereny, Natasha B Leighl, Myung-Ju Ahn, Joseph Paul Eder, Ani S Balmanoukian, Charu Aggarwal, Leora Horn and 9 more

3 registry-linked trialsAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2019. 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 704 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
704citing papers in PubMed, 5 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.

NCT05378334 narecruitingnot on this mapstarted 2022, after this paper: background citation

Efficacy and Safety of Bone-protecting and Mass-dispersesing Decoction (HuGuXiaoJiTang, HGXJT) Combining With ICIs in Bone Metastatic NSCLC Patients

TypeinterventionalSponsorGuangzhou University of Traditional Chinese MedicineRan2022 to 2028Enrolled82ConditionsNon-small Cell Lung CancerArmsICI, Chemotherapy, Placebo, Bone-protecting and Mass-dispersesing Decoction
NCT05885815 unknown statusnot on this mapstarted 2023, after this paper: background citation

Application of Surface-enhanced Raman Scatting (SERS) Technology in Clinical Diagnosis and Prognosis of Lung Cancer Immunotherapy

TypeobservationalSponsorShanghai Pulmonary Hospital, Shanghai, ChinaRan2023 to 2025Enrolled500ConditionsLung Cancer
NCT06518018 unknown statusnot on this mapstarted 2023, after this paper: background citation

Exploring the Efficacy and Safety of High-Dose Rate Brachytherapy Combined With Immunotherapy and Chemotherapy as a Second-Line Treatment in Patients With Advanced Non-Small Cell Lung Cancer: A Single-Center, Retrospective, Propensity Score-Matched Study

TypeobservationalSponsorThe First People's Hospital of NeijiangRan2023 to 2025Enrolled80ConditionsAdvanced Stage NSCLC, Second-line Treatment, Patients Without Targetable Driver MutationsArmsHDR brachytherapy (30Gy single fraction), Immunotherapy
3 · Its place in the literature

Who cites it

704 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Guideline
  6. Trial
  7. Rilvegostomig for Metastatic Non-Small Cell Lung Cancer: A First-In-Human Phase I/II Clinical Study.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Trial
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  9. Trial
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  11. Trial
  12. Article
  13. Article
  14. Review
  15. Article
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  18. Fully intravenous split-dose administration of the oncolytic adenovirus TILT-123 in advanced solid tumors.Molecular therapy : the journal of the American Society of Gene Therapy · 2026
    Article
  19. Review
  20. Article

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors.

Edward B GaronUniversity of California, Los Angeles, Los Angeles, CA.
Matthew D HellmannMemorial Sloan Kettering Cancer Center, New York, NY.
Naiyer A RizviColumbia University Medical Center, New York, NY.
Enric CarcerenyCatalan Institute of Oncology Badalona, Badalona, Spain.
Natasha B LeighlPrincess Margaret Cancer Centre, Toronto, Ontario, Canada.
Myung-Ju AhnSamsung Medical Center, Seoul, South Korea.
Joseph Paul EderYale University, New Haven, CT.
Ani S BalmanoukianThe Angeles Clinic and Research Institute, Los Angeles, CA.
Charu AggarwalUniversity of Pennsylvania, Philadelphia, PA.
Leora HornVanderbilt-Ingram Cancer Center, Nashville, TN.
Amita PatnaikSouth Texas Accelerated Research Therapeutics, San Antonio, TX.
Matthew GubensUniversity of California, San Francisco, San Francisco, CA.
Suresh S RamalingamEmory University, Atlanta, GA.
Enriqueta FelipVall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain.
Jonathan W GoldmanUniversity of California, Los Angeles, Los Angeles, CA.
Cathie ScalzoMerck & Co., Inc., Kenilworth, NJ.
Erin JensenMerck & Co., Inc., Kenilworth, NJ.
Debra A KushMerck & Co., Inc., Kenilworth, NJ.
Rina HuiWestmead Hospital, University of Sydney, Sydney, NSW, Australia.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposePembrolizumab monotherapy has demonstrated durable antitumor activity in advanced programmed death ligand 1 (PD-L1)-expressing non PATIENTS AND

methodsEligible patients had confirmed locally advanced/metastatic NSCLC and provided a contemporaneous tumor sample for PD-L1 evaluation by immunohistochemistry using the 22C3 antibody. Patients received intravenous pembrolizumab 2 mg/kg every 3 weeks or 10 mg/kg every 2 or 3 weeks. Investigators assessed response per immune-related response criteria. The primary efficacy end point was objective response rate. Overall survival (OS) and duration of response were secondary end points.

resultsWe enrolled 101 treatment-naive and 449 previously treated patients. Median follow-up was 60.6 months (range, 51.8 to 77.9 months). At data cutoff-November 5, 2018-450 patients (82%) had died. Median OS was 22.3 months (95% CI, 17.1 to 32.3 months) in treatment-naive patients and 10.5 months (95% CI, 8.6 to 13.2 months) in previously treated patients. Estimated 5-year OS was 23.2% for treatment-naive patients and 15.5% for previously treated patients. In patients with a PD-L1 tumor proportion score of 50% or greater, 5-year OS was 29.6% and 25.0% in treatment-naive and previously treated patients, respectively. Compared with analysis at 3 years, only three new-onset treatment-related grade 3 adverse events occurred (hypertension, glucose intolerance, and hypersensitivity reaction, all resolved). No late-onset grade 4 or 5 treatment-related adverse events occurred.

conclusionPembrolizumab monotherapy provided durable antitumor activity and high 5-year OS rates in patients with treatment-naive or previously treated advanced NSCLC. Of note, the 5-year OS rate exceeded 25% among patients with a PD-L1 tumor proportion score of 50% or greater. Pembrolizumab had a tolerable long-term safety profile with little evidence of late-onset or new toxicity.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCarcinoma, Non-Small-Cell LungFemaleHumansLung NeoplasmsMaleMiddle AgedSurvival RateTime FactorsAntibodies, Monoclonal, HumanizedAntineoplastic Agents, Immunologicalpembrolizumab

Identifiers

PMID31154919
PMCPMC6768611

What OpenQuestion holds

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LicenceCC BY-NC-ND
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.