{"entity":{"id":"paper-nct02864992-jama-oncol-2023-update","kind":"paper","name":"Tepotinib Treatment in Patients With MET Exon 14-Skipping Non-Small Cell Lung Cancer: Long-term Follow-up of the VISION Phase 2 Nonrandomized Clinical Trial","aka":[],"tldr":"Later report from the trial registered as NCT02864992, in JAMA Oncology (2023); its title describes an updated or longer-term analysis.","summary":"Importance: MET inhibitors have recently demonstrated clinical activity in patients with MET exon 14 (METex14)-skipping non-small cell lung cancer (NSCLC); however, data with longer follow-up and in larger populations are needed to further optimize therapeutic approaches.\n\nObjective: To assess the long-term efficacy and safety of tepotinib, a potent and highly selective MET inhibitor, in patients with METex14-skipping NSCLC in the VISION study.\n\nDesign, setting, and participants: The VISION phase 2 nonrandomized clinical trial was a multicohort, open-label, multicenter study that enrolled patients with METex14-skipping advanced/metastatic NSCLC (cohorts A and C) from September 2016 to May 2021. Cohort C (>18 months' follow-up) was an independent cohort, designed to confirm findings from cohort A (>35 months' follow-up). Data cutoff was November 20, 2022.\n\nIntervention: Patients received tepotinib, 500 mg (450 mg active moiety), once daily.\n\nMain outcomes and measures: The primary end point was objective response by independent review committee (RECIST v1.1). Secondary end points included duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety.\n\nResults: Cohorts A and C included 313 patients (50.8% female, 33.9% Asian; median [range] age, 72 [41-94] years). The objective response rate (ORR) was 51.4% (95% CI, 45.8%-57.1%) with a median (m)DOR of 18.0 (95% CI, 12.4-46.4) months. In cohort C (n = 161), an ORR of 55.9% (95% CI, 47.9%-63.7%) with an mDOR of 20.8 (95% CI, 12.6-not estimable [NE]) months was reported across treatment lines, comparable to cohort A (n = 152). In treatment-naive patients (cohorts A and C; n = 164), ORR was 57.3% (95% CI, 49.4%-65.0%) and mDOR was 46.4 (95% CI, 13.8-NE) months. In previously treated patients (n = 149), ORR was 45.0% (95% CI, 36.8%-53.3%) and mDOR was 12.6 (95% CI, 9.5-18.5) months. Peripheral edema, the most common treatment-related adverse event, occurred in 210 patients (67.1%) (35 [11.2%] experienced grade ≥3 events).\n\nConclusions and relevance: The findings from cohort C in this nonrandomized clinical trial supported the results from original cohort A. Overall, the long-term outcomes of VISION demonstrated robust and durable clinical activity following treatment with tepotinib, particularly in the treatment-naive setting, in the largest known clinical trial of patients with METex14-skipping NSCLC, supporting the global approvals of tepotinib and enabling clinicians to implement this therapeutic approach for such patients.\n\nTrial registration: ClinicalTrials.gov Identifier: NCT02864992.\n\nIndexed on Europe PMC as PubMed record 37270698 (DOI 10.1001/jamaoncol.2023.1962). Its abstract cites the registry id NCT02864992, which is how it was matched to this trial; no figure has been checked by an editor.","asOf":"2026-09-22","links":[{"label":"JAMA Oncol 2023","url":"https://doi.org/10.1001/jamaoncol.2023.1962"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/37270698/"},{"label":"Europe PMC","url":"https://europepmc.org/article/MED/37270698"},{"label":"ClinicalTrials.gov NCT02864992","url":"https://clinicaltrials.gov/study/NCT02864992"}],"tags":["europepmc-ingest"],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["nct02864992"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["jama-oncology"],"dependsOn":[],"notes":[],"journal":"JAMA Oncology","year":2023,"doi":"10.1001/jamaoncol.2023.1962","pmid":"37270698","authors":"Mazieres J, Paik PK, Garassino MC, et al.","paperType":"observational","findings":[],"whatItMeans":"A second publication from the trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.","caveats":["Matched to the trial by the registry id cited in the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.","Chosen as a later report by words in its title (updated, long-term, final, overall survival or a year count), not by reading the paper."]},"route":"/key-papers/paper-nct02864992-jama-oncol-2023-update/","neighbours":{"trial":[{"id":"nct02864992","kind":"trial","name":"Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)","route":"/trials/nct02864992/"}],"journal":[{"id":"jama-oncology","kind":"journal","name":"JAMA Oncology","route":"/journals/jama-oncology/"}]}}