Evidence map›Paper›PMID 36971777›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2023

Randomized Trial of Tepotinib Plus Gefitinib versus Chemotherapy in EGFR-Mutant NSCLC with EGFR Inhibitor Resistance Due to MET Amplification: INSIGHT Final Analysis.

Chong Kin Liam, Azura Rozila Ahmad, Te-Chun Hsia, Jianying Zhou, Dong-Wan Kim, Ross Andrew Soo, Ying Cheng, Shun Lu, Sang Won Shin, James Chih-Hsin Yang and 6 more

Open access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 2 pooled it
9.8field-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

28 citing papers in PubMed, 2 syntheses or guidelines pooled it, 38 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 14 institutions in 7 countries.

Chong Kin LiamDepartment of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.ORCID 0000-0002-3639-9231
Azura Rozila AhmadBeacon International Specialist Centre Sdn Bhd, Selangor, Malaysia.ORCID 0000-0003-3301-8656
Te-Chun HsiaChina Medical University Hospital, Taichung City, Taiwan.ORCID 0000-0003-4297-9918
Jianying ZhouThe First Affiliated Hospital, Zhejiang University, Hangzhou, China.ORCID 0000-0002-8924-935X
Dong-Wan KimSeoul National University Hospital, Seoul, South Korea.ORCID 0000-0001-5124-7132
Ross Andrew SooNational University Cancer Institute, Singapore.ORCID 0000-0002-3053-3997
Ying ChengJilin Province Cancer Hospital, Changchun, China.ORCID 0000-0001-9908-597X
Shun LuShanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.ORCID 0000-0001-8833-7262
Sang Won ShinKorea University Anam Hospital, Seoul, South Korea.ORCID 0000-0002-9182-1589
James Chih-Hsin YangNational Taiwan University Hospital, Taipei, Taiwan.ORCID 0000-0002-5586-5138
Yiping ZhangZhejiang Cancer Hospital, Hangzhou, China.ORCID 0009-0000-2833-8626
Jun ZhaoDepartment of Thoracic Oncology, Peking University Cancer Hospital and Institute, Beijing, China.ORCID 0000-0003-1464-7158
Karin BerghoffGlobal Patient Safety, the healthcare business of Merck KGaA, Darmstadt, Germany.ORCID 0000-0002-6310-3379
Rolf BrunsDepartment of Biostatistics, the healthcare business of Merck KGaA, Darmstadt, Germany.ORCID 0000-0003-2305-3765
Andreas JohneGlobal Clinical Development, the healthcare business of Merck KGaA, Darmstadt, Germany.ORCID 0000-0003-2690-2857
Yi-Long WuGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital & Guangdong Academy of Medical Sciences, Guangzhou, China.ORCID 0000-0002-3611-0258
Merck (Germany) · DEChina Medical University · TWCity University College of Science and Technology · MYFirst Affiliated Hospital Zhejiang University · CNGuangdong Academy of Medical Sciences · CNJilin Province Tumor Hospital · CNKorea University · KRNational Taiwan University Hospital · TWNational University Cancer Institute, Singapore · SGPeking University · CNSeoul National University Hospital · KRShanghai Chest Hospital · CNUniversity of Malaya · MYZhejiang Cancer Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe final analyses of the INSIGHT phase II study evaluating tepotinib (a selective MET inhibitor) plus gefitinib versus chemotherapy in patients with MET-altered EGFR-mutant NSCLC (data cut-off: September 3, 2021). PATIENTS AND

methodsAdults with advanced/metastatic EGFR-mutant NSCLC, acquired resistance to first-/second-generation EGFR inhibitors, and MET gene copy number (GCN) ≥5, MET:CEP7 ≥2, or MET IHC 2+/3+ were randomized to tepotinib 500 mg (450 mg active moiety) plus gefitinib 250 mg once daily, or chemotherapy. Primary endpoint was investigator-assessed progression-free survival (PFS). MET-amplified subgroup analysis was preplanned.

resultsOverall (N = 55), median PFS was 4.9 months versus 4.4 months [stratified HR, 0.67; 90% CI, 0.35-1.28] with tepotinib plus gefitinib versus chemotherapy. In 19 patients with MET amplification (median age 60.4 years; 68.4% never-smokers; median GCN 8.8; median MET/CEP7 2.8; 89.5% with MET IHC 3+), tepotinib plus gefitinib improved PFS (HR, 0.13; 90% CI, 0.04-0.43) and overall survival (OS; HR, 0.10; 90% CI, 0.02-0.36) versus chemotherapy. Objective response rate was 66.7% with tepotinib plus gefitinib versus 42.9% with chemotherapy; median duration of response was 19.9 months versus 2.8 months. Median duration of tepotinib plus gefitinib was 11.3 months (range, 1.1-56.5), with treatment >1 year in six (50.0%) and >4 years in three patients (25.0%). Seven patients (58.3%) had treatment-related grade ≥3 adverse events with tepotinib plus gefitinib and five (71.4%) had chemotherapy.

conclusionsFinal analysis of INSIGHT suggests improved PFS and OS with tepotinib plus gefitinib versus chemotherapy in a subgroup of patients with MET-amplified EGFR-mutant NSCLC, after progression on EGFR inhibitors.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsAdultAntineoplastic Combined Chemotherapy ProtocolsDisease-Free SurvivalErbB ReceptorsGefitinibHumansMiddle AgedMutationPiperidinesProtein Kinase InhibitorsPyridazinesPyrimidinesEGFR protein, humanErbB ReceptorsGefitinibPiperidinesProtein Kinase InhibitorsPyridazinesPyrimidinestepotinib

Identifiers

PMID36971777
PMCPMC10183805
OpenAlexW4361000448

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

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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.