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GEOMETRY mono-1

Study of Oral cMET Inhibitor INC280 in Patients With EGFR Wild-type (wt), Advanced Non-small Cell Lung Cancer (NSCLC) (Geometry Mono-1)

Phase 2N = 364NCT02414139

Population
Advanced NSCLC with MET exon 14 skipping mutation or MET amplification (364 patients assigned to cohorts)
Design
Multiple-cohort phase 2 study of capmatinib 400 mg tablets twice daily in MET-dysregulated advanced NSCLC; cohorts defined by previous lines of therapy and MET status (exon 14 skipping mutation or MET amplification by gene copy number). Primary endpoint overall response and key secondary endpoint response duration, both by an independent review committee.
Primary endpoint
ORR
Arms
  • Capmatinib (experimental, n = 364): Capmatinib 400 mg tablet orally twice daily
People
Wolf J
Show the numbers
Results reported for GEOMETRY mono-1
EndpointAnalysisCapmatinibControlEffect
ORRMET exon 14 skipping mutation, one or two previous lines of therapy (n=69)Complete or partial response by an independent review committeeprimaryWolf 202041% (29–53%)—69 patients with MET exon 14 skipping had received one or two previous lines of therapy.
DORMET exon 14 skipping mutation, one or two previous lines (n=69)primaryWolf 2020median 9.7 months (5.6–13.0)——
ORRMET exon 14 skipping mutation, previously untreated (n=28)Complete or partial response by an independent review committeeprimaryWolf 202068% (48–84%)——
DORMET exon 14 skipping mutation, previously untreated (n=28)primaryWolf 2020median 12.6 months—95% CI 5.6 to could not be estimated.
Results reported for GEOMETRY mono-1
EndpointAnalysisCapmatinibControlEffect
ORRMET exon 14 skipping mutation, one or two previous lines of therapy (n=69)Complete or partial response by an independent review committeeprimaryWolf 202041% (29–53%)—69 patients with MET exon 14 skipping had received one or two previous lines of therapy.
DORMET exon 14 skipping mutation, one or two previous lines (n=69)primaryWolf 2020median 9.7 months (5.6–13.0)——
ORRMET exon 14 skipping mutation, previously untreated (n=28)Complete or partial response by an independent review committeeprimaryWolf 202068% (48–84%)——
DORMET exon 14 skipping mutation, previously untreated (n=28)primaryWolf 2020median 12.6 months—95% CI 5.6 to could not be estimated.
Illustrative — modelled from reported values, not trial data. DOR, primary.
0%25%50%75%100%05101520Months (modelled)
  • Capmatinib (experimental)

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

Data table (modelled values)
MonthsCapmatinib
0100.0%
665.1%
1242.4%
1827.6%
2418.0%
Illustrative — modelled from reported values, not trial data. DOR, primary.
0%25%50%75%100%051015202530Months (modelled)
  • Capmatinib (experimental)

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

Data table (modelled values)
MonthsCapmatinib
0100.0%
864.4%
1641.5%
2426.7%
3217.2%
Primary publication: Wolf J, Seto T, Han JY, Reguart N, Garon EB, Groen HJM, et al. Capmatinib in MET Exon 14-Mutated or MET-Amplified Non-Small-Cell Lung Cancer. N Engl J Med. 2020;383(10):944-957. PubMedDOI

Appears in

Sources

  1. Wolf J, Seto T, Han JY, Reguart N, Garon EB, Groen HJM, et al. Capmatinib in MET Exon 14-Mutated or MET-Amplified Non-Small-Cell Lung Cancer. N Engl J Med. 2020;383(10):944-957.

    PubMedDOI