Evidence map›Paper›PMID 34607285›Full record

Trial reportESMO open2021

First-line nivolumab plus ipilimumab with two cycles of chemotherapy versus chemotherapy alone (four cycles) in advanced non-small-cell lung cancer: CheckMate 9LA 2-year update.

M Reck, T-E Ciuleanu, M Cobo, M Schenker, B Zurawski, J Menezes, E Richardet, J Bennouna, E Felip, O Juan-Vidal and 17 more

Erratum issuedOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in ESMO open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 106 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
106citing papers in PubMed, 15 pooled it
13.9field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

106 citing papers in PubMed, 15 syntheses or guidelines pooled it, 185 citations in OpenAlex.

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  3. Use of PD-1/PD-L1 inhibitors in non-small cell lung cancer in elderly patients: a meta-analysis and systematic review of randomized clinical trials.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
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46 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors at 20 institutions in 12 countries.

M ReckDepartment of Thoracic Oncology, Airway Research Center North, German Center for Lung Research, LungClinic, Grosshansdorf, Germany. Electronic address: m.reck@lungenclinic.de.
T-E CiuleanuDepartment of Oncology, Institutul Oncologic Prof Dr Ion Chiricuta and UMF Iuliu Hatieganu, Cluj-Napoca, Romania.
M CoboDepartment of Medical Oncology, Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen de la Victoria, IBIMA, Málaga, Spain.
M SchenkerDepartment of Oncology, SF Nectarie Oncology Center, Craiova, Romania.
B ZurawskiDepartment of Clinical Oncology, Ambulatorium Chemioterapii, Bydgoszcz, Poland.
J MenezesDepartment of Oncology, Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil.
E RichardetDepartment of Clinical Oncology, Instituto Oncológico de Córdoba, Córdoba, Argentina.
J BennounaDepartment of Thoracic Oncology, University Hospital of Nantes and INSERM, CRCINA, Nantes, France.
E FelipDepartment of Medical Oncology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona.
O Juan-VidalDepartment of Medical Oncology, Hospital Universitario La Fe, Valencia, Spain.
A AlexandruDepartment of Oncology, Institute of Oncology Prof Dr Alexandru Trestioreanu Bucha, Bucharest, Romania.
H SakaiDepartment of Thoracic Oncology, Saitama Cancer Center, Saitama, Japan.
A LinguaDepartment of Medical Oncology, Instituto Medico Rio Cuarto, SA, Córdoba, Argentina.
F ReyesDepartment of Medical Oncology, Fundación Arturo López Pérez, Santiago, Metropolitana, Chile.
P-J SouquetDepartment of Pneumology, Hôpital Lyon Sud, Lyon, Pierre Bénite, France.
P De MarchiDepartment of Oncology, Barretos Cancer Hospital, Barretos, Brazil.
C MartinDepartment of Thoracic Oncology, Instituto Alexander Fleming, Buenos Aires, Argentina.
M PérolDepartment of Thoracic Oncology, Léon Bérard Cancer Center, Lyon, France.
A ScherpereelDepartment of Pulmonary and Thoracic Oncology, University of Lille, CHU Lille, INSERM U1189, OncoThAI, Lille, France.
S LuDepartment of Medical Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai JiaoTong University, Shanghai, China.
L Paz-AresDepartment of Medical Oncology, Hospital Universitario 12 de Octubre, CNIO-H12o Lung Cancer Clinical Research Unit, Universidad Complutense & CiberOnc, Madrid, Spain.
D P CarboneDepartment of Medical Oncology, The Ohio State University Comprehensive Cancer Center, Columbus, USA.
A MemajBristol Myers Squibb, Princeton, USA.
S MarimuthuBristol Myers Squibb, Princeton, USA.
X ZhangBristol Myers Squibb, Princeton, USA.
P TranBristol Myers Squibb, Princeton, USA.
T JohnDepartment of Medical Oncology, Austin Hospital, Heidelberg, Australia.
Bristol-Myers Squibb (United States) · USAustin Hospital · AUCentre de Recherche en Cancérologie de Lyon · FRCentre Hospitalier Universitaire de Lille · FRFundación Arturo López Pérez · CLGerman Center for Lung Research · DEHebron University · PSHôpital Lyon Sud · FRHospital de Câncer de Barretos · BRHospital Nossa Senhora da Conceição · BRHospital Universitari i Politècnic La Fe · ESHospital Universitario 12 De Octubre · ESInserm · FRInstitute of Oncology Prof. Dr. Ion Chiricuta · ROInstituto Alexander Fleming · ARInstituto de Investigación Biomédica de Málaga · ESInstituto Médico Río Cuarto · ARInstituto Oncológico de Córdoba · ARInstitutul Oncologic Bucuresti · ROSaitama Cancer Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo further characterize survival benefit with first-line nivolumab plus ipilimumab with two cycles of chemotherapy versus chemotherapy alone, we report updated data from the phase III CheckMate 9LA trial with a 2-year minimum follow-up. PATIENTS AND

methodsAdult patients were treatment naïve, with stage IV/recurrent non-small-cell lung cancer, no known sensitizing EGFR/ALK alterations, and an Eastern Cooperative Oncology Group performance status ≤1. Patients were randomized 1 : 1 to nivolumab 360 mg every 3 weeks plus ipilimumab 1 mg/kg every 6 weeks with two cycles of chemotherapy, or four cycles of chemotherapy. Updated efficacy and safety outcomes are reported, along with progression-free survival (PFS) after next line of treatment (PFS2), treatment-related adverse events (TRAEs) by treatment cycle, and efficacy outcomes in patients who discontinued all treatment components in the experimental arm due to TRAEs.

resultsWith a median follow-up of 30.7 months, nivolumab plus ipilimumab with chemotherapy continued to prolong overall survival (OS) versus chemotherapy. Median OS was 15.8 versus 11.0 months [hazard ratio 0.72 (95% confidence interval 0.61-0.86)]; 2-year OS rate was 38% versus 26%. Two-year PFS rate was 20% versus 8%. ORR was 38% versus 25%, respectively; 34% versus 12% of all responses were ongoing at 2 years. Median PFS2 was 13.9 versus 8.7 months. Improved efficacy outcomes in the experimental versus control arm were observed across most subgroups, including by programmed death-ligand 1 and histology. No new safety signals were observed; onset of grade 3/4 TRAEs was mostly observed during the first two treatment cycles in the experimental arm. In patients who discontinued all components of nivolumab plus ipilimumab with chemotherapy treatment due to TRAEs (n = 61) median OS was 27.5 months; 56% of responders had an ongoing response ≥1 year after discontinuation.

conclusionsWith a 2-year minimum follow-up, nivolumab plus ipilimumab with two cycles of chemotherapy provided durable efficacy benefits over chemotherapy with a manageable safety profile and remains an efficacious first-line treatment of advanced non-small-cell lung cancer.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsHumansIpilimumabNeoplasm Recurrence, LocalNivolumabIpilimumabNivolumabdual immunotherapyfirst-lineipilimumabnivolumabNSCLC

Identifiers

PMID34607285
PMCPMC8493593
OpenAlexW3204952685

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.