Evidence map›Paper›PMID 36308296›Full record

Trial reportCancer2023

Patient-reported outcomes with cemiplimab monotherapy for first-line treatment of advanced non-small cell lung cancer with PD-L1 of ≥50%: The EMPOWER-Lung 1 study.

Mahmut Gümüş, Chieh-I Chen, Cristina Ivanescu, Saadettin Kilickap, Igor Bondarenko, Mustafa Özgüroğlu, Miranda Gogishvili, Haci M Turk, Irfan Cicin, James Harnett and 10 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03088540 (A Global, Randomised, Phase 3, Open-label Study of REGN2810), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.8field-weighted citation impact, top 13% 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.

NCT03088540 phase3completednot on this map

A Global, Randomised, Phase 3, Open-label Study of REGN2810 (ANTI-PD 1 Antibody) Versus Platinum Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic PD L1+Non-small Cell Lung Cancer

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2017 to 2025Enrolled712ConditionsCarcinoma,Non-Small-Cell Lung, Lung Carcinomas, Non-Small-Cell, Non-small-cell Lung Carcinoma, Nonsmall Cell Lung CancerArmsPemetrexed, Paclitaxel, Gemcitabine, Cisplatin, Carboplatin
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 20 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 12 institutions in 5 countries.

Mahmut GümüşIstanbul Medeniyet University, Faculty of Medicine, Istanbul, Turkey.ORCID 0000-0003-3550-9993
Chieh-I ChenRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Cristina IvanescuIQVIA, Amsterdam, The Netherlands.
Saadettin KilickapDepartment of Medical Oncology, Istinye University Faculty of Medicine Liv Hospital, Ankara, Turkey.
Igor BondarenkoDnipropetrovsk State Medical Academy, City Multifield Clinical Hospital, Dnipropetrovsk, Ukraine.
Mustafa ÖzgüroğluCerrahpaşa Medical Faculty, Istanbul University-Cerrahpaşa, Istanbul, Turkey.
Miranda GogishviliHigh Technology Medical Centre, Tbilisi, Georgia.
Haci M TurkDepartment of Medical Oncology, Bezmialem Vakif University, Medical Faculty, Istanbul, Turkey.
Irfan CicinDepartment of Medical Oncology, Trakya University, İskender/Edirne Merkez/Edirne, Turkey.
James HarnettRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Vera MasteyRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Ulrike NaumannIQVIA, Reading, UK.
Matthew ReaneyIQVIA, Reading, UK.
Gerasimos KonidarisSanofi, Reading, UK.
Medha SasaneSanofi, Bridgewater, New Jersey, USA.
Keri J S BradySanofi, Cambridge, Massachusetts, USA.
Siyu LiRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Giuseppe GulloRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Petra RietschelRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Ahmet SezerDepartment of Medical Oncology, Başkent University, Etimesgut, Ankara, Turkey.
Regeneron (United States) · USIQVIA (United Kingdom) · GBSanofi (United States) · USBaşkent University · TRBezmiâlem Vakıf Üniversitesi · TRDnipro State Medical University · UAIstanbul Medeniyet University · TRIstanbul University-Cerrahpaşa · TRIstinye University · TRSanofi (United Kingdom) · GBTbilisi State Medical University · GETrakya University · TR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the EMPOWER-Lung 1 trial (ClinicalTrials.gov, NCT03088540), cemiplimab conferred longer survival than platinum-doublet chemotherapy for advanced non-small cell lung cancer (NSCLC) with programmed cell death-ligand 1 (PD-L1) ≥50%. Patient-reported outcomes were evaluated among trial participants.

methodsAdults with NSCLC and Eastern Cooperative Oncology Group performance status 0 to 1 were randomly assigned cemiplimab 350 mg every 3 weeks or platinum-doublet chemotherapy. At baseline and day 1 of each treatment cycle, patients were administered the European Organization for Research and Treatment of Cancer Quality of Life-Core 30 (QLQ-C30) and Lung Cancer Module (QLQ-LC13) questionnaires. Mixed-model repeated measures analysis estimated overall change from baseline for PD-L1 ≥50% and intention-to-treat populations. Kaplan-Meier analysis estimated time to definitive deterioration.

resultsIn PD-L1 ≥50% patients (cemiplimab, n = 283; chemotherapy, n = 280), baseline QLQ-C30 and QLQ-LC13 scores showed moderate-to-high functioning and low symptom burden. Change from baseline favored cemiplimab on global health status/quality of life (GHS/QOL), functioning, and most symptom scales. Risk of definitive deterioration across functioning scales was reduced versus chemotherapy; hazard ratios were 0.48 (95% CI, 0.32-0.71) to 0.63 (95% CI, 0.41-0.96). Cemiplimab showed lower risk of definitive deterioration for disease-related (dyspnea, cough, pain in chest, pain in other body parts, fatigue) and treatment-related symptoms (peripheral neuropathy, alopecia, nausea/vomiting, appetite loss, constipation, diarrhea) (nominal p < .05). Results were similar in the intention-to-treat population.

conclusionsResults support cemiplimab for first-line therapy of advanced NSCLC from the patient's perspective. Improved survival is accompanied by improvements versus platinum-doublet chemotherapy in GHS/QOL and functioning and reduction in symptom burden.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCarcinoma, Non-Small-Cell LungLung NeoplasmsAdultB7-H1 AntigenHumansLungPainPatient Reported Outcome MeasuresPlatinumQuality of LifeAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalB7-H1 AntigencemiplimabPlatinumcemiplimabnon-small cell lung cancerpatient-reported outcomesquality of lifesymptom burden

Identifiers

PMID36308296
PMCPMC10092585
OpenAlexW4307583706

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.