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Bending the Curve Trial by Trial
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VISION

Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)

Phase 2N = 152NCT02864992

Population
Advanced or metastatic NSCLC with a confirmed MET exon 14 skipping mutation (152 patients had received tepotinib as of 1 January 2020; 99 had at least 9 months of follow-up)
Design
Open-label phase 2 study of tepotinib 500 mg once daily in advanced or metastatic NSCLC with a confirmed MET exon 14 skipping mutation. Primary endpoint objective response by independent review among patients with at least 9 months of follow-up; response also analysed by liquid-biopsy or tissue-biopsy detection.
Primary endpoint
ORR
Arms
  • Tepotinib (experimental, n = 152): Tepotinib 500 mg orally once daily
People
Paik PK
Show the numbers
Results reported for VISION
EndpointAnalysisTepotinibControlEffect
ORRPatients with at least 9 months of follow-up, combined-biopsy group (n=99)Objective response by independent reviewprimaryPaik 202046% (36–57%)—Liquid-biopsy group (n=66): 48% (95% CI 36 to 61); tissue-biopsy group (n=60): 50% (95% CI 37 to 63); 27 patients were positive by both methods.
DORCombined-biopsy group (n=99)primaryPaik 2020median 11.1 months—95% CI 7.2 to could not be estimated.
ORREfficacy population (n=99, at least 9 months of follow-up, combined-biopsy group)Investigator-assessed objective responseexploratoryPaik 202056% (45–66%)—Investigator-assessed response rate, reported as similar regardless of the previous therapy received (abstract). Grade 3 or higher tepotinib-related adverse events 28%, including peripheral oedema 7%. 'Exploratory' is used as the closest label in the schema's analysis vocabulary; the paper does not use it.
Results reported for VISION
EndpointAnalysisTepotinibControlEffect
ORRPatients with at least 9 months of follow-up, combined-biopsy group (n=99)Objective response by independent reviewprimaryPaik 202046% (36–57%)—Liquid-biopsy group (n=66): 48% (95% CI 36 to 61); tissue-biopsy group (n=60): 50% (95% CI 37 to 63); 27 patients were positive by both methods.
DORCombined-biopsy group (n=99)primaryPaik 2020median 11.1 months—95% CI 7.2 to could not be estimated.
ORREfficacy population (n=99, at least 9 months of follow-up, combined-biopsy group)Investigator-assessed objective responseexploratoryPaik 202056% (45–66%)—Investigator-assessed response rate, reported as similar regardless of the previous therapy received (abstract). Grade 3 or higher tepotinib-related adverse events 28%, including peripheral oedema 7%. 'Exploratory' is used as the closest label in the schema's analysis vocabulary; the paper does not use it.
Illustrative — modelled from reported values, not trial data. DOR, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Tepotinib (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsTepotinib
0100.0%
764.6%
1441.7%
2126.9%
2817.4%
Primary publication: Paik PK, Felip E, Veillon R, Sakai H, Cortot AB, Garassino MC, et al. Tepotinib in Non-Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations. N Engl J Med. 2020;383(10):931-943. PubMedDOI

Appears in

Sources

  1. Paik PK, Felip E, Veillon R, Sakai H, Cortot AB, Garassino MC, et al. Tepotinib in Non-Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations. N Engl J Med. 2020;383(10):931-943.

    PubMedDOI