Evidence map›Paper›PMID 31446994›Full record

ArticleLung cancer (Amsterdam, Netherlands)2019

Safety and efficacy of pembrolizumab monotherapy in elderly patients with PD-L1-positive advanced non-small-cell lung cancer: Pooled analysis from the KEYNOTE-010, KEYNOTE-024, and KEYNOTE-042 studies.

Kaname Nosaki, Hideo Saka, Yukio Hosomi, Paul Baas, Gilberto de Castro, Martin Reck, Yi-Long Wu, Julie R Brahmer, Enriqueta Felip, Takeshi Sawada and 5 more

3 registry-linked trialsAbstract read
PubMed Publisher
In one paragraph

Article in Lung cancer (Amsterdam, Netherlands), 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 162 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
162citing papers in PubMed, 8 pooled it
14.9field-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.

NCT01905657 phase2 / phase3completednot on this map

A Phase II/III Randomized Trial of Two Doses of MK-3475 (SCH900475) Versus Docetaxel in Previously Treated Subjects With Non-Small Cell Lung Cancer

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2013 to 2020Enrolled1,034ConditionsNon Small Cell Lung Cancer (NSCLC)ArmsPembrolizumab, Docetaxel
NCT02142738 phase3completednot on this map

A Randomized Open-Label Phase III Trial of Pembrolizumab Versus Platinum Based Chemotherapy in 1L Subjects With PD-L1 Strong Metastatic Non-Small Cell Lung Cancer

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2014 to 2021Enrolled305ConditionsNon-Small Cell Lung CarcinomaArmsPembrolizumab, Paclitaxel, Carboplatin, Pemetrexed, Cisplatin
NCT02220894 phase3completednot on this map

A Randomized, Open Label, Phase III Study of Overall Survival Comparing Pembrolizumab (MK-3475) Versus Platinum Based Chemotherapy in Treatment Naïve Subjects With PD-L1 Positive Advanced or Metastatic Non-Small Cell Lung Cancer (Keynote 042)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2014 to 2022Enrolled1,274ConditionsNon-small Cell Lung CancerArmspembrolizumab, carboplatin, paclitaxel, pemetrexed
3 · Its place in the literature

Who cites it

162 citing papers in PubMed, 8 syntheses or guidelines pooled it, 277 citations in OpenAlex.

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  17. Current and future immunotherapies for NSCLC.Journal of hematology & oncology · 2026
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102 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 12 institutions in 8 countries.

Kaname NosakiNational Hospital Organization Kyushu Cancer Center, Minami-ku, Fukuoka-shi, Fukuoka 811-1395, Japan. Electronic address: knosaki@east.ncc.go.jp.
Hideo SakaNational Hospital Organization Nagoya Medical Center, 4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi 460-0001, Japan. Electronic address: hideosaka@me.com.
Yukio HosomiTokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan. Electronic address: yhosomi@cick.jp.
Paul BaasThe Netherlands Cancer Institute, Postbus 90203, 1006 BE Amsterdam, the Netherlands. Electronic address: p.baas@nki.nl.
Gilberto de CastroInstituto do Câncer do Estado de São Paulo, Av. Dr. Arnaldo, 251 - Cerqueira César, São Paulo, SP 01246-000, Brazil. Electronic address: gilberto.castro@usp.br.
Martin ReckLung Clinic Grosshansdorf, Airway Research Center North (ARCN), member of the German Center for Lung Research (DZL), Wöhrendamm 80, 22927 Grosshansdorf, Germany. Electronic address: M.Reck@lungenclinic.de.
Yi-Long WuGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, and Guangdong Academy of Medical Sciences, Guangdong, 106 Zhongshan 2nd Rd, Yuexiu Qu, Guangzhou Shi, Guangdong Sheng 510080, China. Electronic address: syylwu@live.cn.
Julie R BrahmerSidney Kimmel Comprehensive Cancer Center at Johns Hopkins, 1650 Orleans St, Baltimore, 21287 MD, USA. Electronic address: brahmju@jhmi.edu.
Enriqueta FelipVall d'Hebron University Hospital, P. Vall d'Hebron, 119-129, 08035 and IOB Quiron, Barcelona, Spain. Electronic address: efelip@vhio.net.
Takeshi SawadaMSD K.K., Kitanomaru Square, 1-13-12, Kudan Kita, Chiyoda-ku, Tokyo 102-8667, Japan. Electronic address: takeshi.sawada@merck.com.
Kazuo NoguchiMSD K.K., Kitanomaru Square, 1-13-12, Kudan Kita, Chiyoda-ku, Tokyo 102-8667, Japan. Electronic address: kazuo.noguchi@merck.com.
Shi Rong HanMSD K.K., Kitanomaru Square, 1-13-12, Kudan Kita, Chiyoda-ku, Tokyo 102-8667, Japan. Electronic address: shi.rong.han@merck.com.
Bilal PiperdiMerck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA. Electronic address: bilal.piperdi@merck.com.
Debra A KushMerck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA. Electronic address: debra_kush@merck.com.
Gilberto LopesSylvester Comprehensive Cancer Center at the University of Miami, 1475 NW 12th Ave, Miami, FL 33136, USA. Electronic address: glopes.md@gmail.com.
MSD K.K. (Japan) · JPMerck & Co., Inc., Rahway, NJ, USA (United States) · USGerman Center for Lung Research · DEGuangdong Academy of Medical Sciences · CNHebron University · PSInstituto do Câncer do Estado de São Paulo · BRNational Hospital Organization · JPNational Hospital Organization Kyushu Cancer Center · JPSidney Kimmel Comprehensive Cancer Center · USThe Netherlands Cancer Institute · NLTokyo Metropolitan Komagome Hospital · JPUniversity of Miami · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesMost lung cancer diagnoses occur in elderly patients, who are underrepresented in clinical trials. We present a pooled analysis of safety and efficacy in elderly patients (≥75 years) who received pembrolizumab (a programmed death 1 inhibitor) for advanced non-small-cell lung cancer (NSCLC) with programmed death ligand 1 (PD-L1)‒positive tumors.

methodsThe pooled analysis included patients aged ≥18 years with advanced NSCLC with PD-L1-positive tumors from the KEYNOTE-010 (NCT01905657), KEYNOTE-024 (NCT02142738), and KEYNOTE-042 (NCT02220894) studies. In KEYNOTE-010, patients were randomized to pembrolizumab 2 or 10 mg/kg every 3 weeks (Q3W) or docetaxel, as second- or later-line therapy. In KEYNOTE-024 and KEYNOTE-042, patients were randomized to first-line pembrolizumab 200 mg Q3W or platinum-based chemotherapy. Overall survival (OS) was estimated by the Kaplan-Meier method, and safety data were summarized in elderly patients (≥75 years).

resultsThe analysis included 264 elderly patients with PD-L1-positive tumors (PD-L1 tumor proportion score [TPS] ≥1%); among these, 132 had PD-L1 TPS ≥ 50%. Pembrolizumab improved OS among elderly patients with PD-L1 TPS ≥ 1% (hazard ratio [HR], 0.76 [95% CI, 0.56-1.02]) and PD-L1 TPS ≥ 50% (HR, 0.40 [95% CI, 0.25-0.64]). Pembrolizumab as first-line therapy also improved OS among elderly patients with PD-L1 TPS ≥ 50% (from KEYNOTE-024 and KEYNOTE-042) compared with chemotherapy (HR, 0.41 [95% CI, 0.23‒0.73]). Pembrolizumab was associated with fewer treatment-related adverse events (AEs) in elderly patients (overall, 68.5% vs 94.3%; grade ≥3, 24.2% vs 61.0%) versus chemotherapy. Immune-mediated AEs and infusion reactions were more common with pembrolizumab versus chemotherapy (overall, 24.8% vs 6.7%; grade 3‒4: 9.4% vs 0%; no grade 5 events).

conclusionsIn this pooled analysis of elderly patients with advanced NSCLC with PD-L1‒positive tumors, pembrolizumab improved OS versus chemotherapy, with a more favorable safety profile. Outcomes with pembrolizumab in patients ≥75 years were comparable to those in the overall populations in the individual studies.

Indexed as

AgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalB7-H1 AntigenBiomarkers, TumorCarcinoma, Non-Small-Cell LungFemaleHumansLung NeoplasmsMaleMutationNeoplasm StagingRandomized Controlled Trials as TopicTreatment OutcomeAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalB7-H1 AntigenBiomarkers, TumorCD274 protein, humanpembrolizumabChemotherapyElderlyNon–small-cell lung cancerPembrolizumabPhase 3Pooled analysis

Identifiers

PMID31446994
OpenAlexW2962053530

What OpenQuestion holds

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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.