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Association details:
Evidence:
Evidence Level:
Sensitive: A2 - Guideline
Source:
Published date:
12/07/2021
Excerpt:
EMERGING BIOMARKERS TO IDENTIFY NOVEL THERAPIES FOR PATIENTS WITH METASTATIC NSCLC...High-level MET amplification...Tepotinib
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Tepotinib With Gefitinib in Participants With Locally Advanced or Metastatic NSCLC (INSIGHT)

Excerpt:
...- MET+ status, as determined by the central laboratory i.e. c-Met overexpression as determined by IHC (i.e., IHC 2+ or IHC 3+) and/or c-Met amplification and/or increased c-Met gene copy number (GCN), both determined by ISH;...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2)

Excerpt:
...- MET amplification as determined by either FISH testing (central or local) on tumor tissue (TBx) or central blood-based next generation sequencing (LBx)....
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

CNS Dose Escalation/Expansion of Tepotinib in MET-driven NSCLC

Excerpt:
...MET amplifications (defined as MET/CEP7 ≥ 4 using FISH) 3....
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Tepotinib in patients with non-small cell lung cancer with high-level MET amplification detected by liquid biopsy: VISION Cohort B

Published date:
11/10/2023
Excerpt:
Cohort B of the phase 2 VISION trial evaluates tepotinib, an oral MET inhibitor, in patients with advanced NSCLC with high-level METamp who were enrolled by liquid biopsy....In exploratory biomarker analyses, focal METamp, RB1 wild-type, MYC diploidy, low circulating tumor DNA (ctDNA) burden at baseline, and early molecular response are associated with better outcomes.
DOI:
10.1016/j.xcrm.2023.101280
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

2304P - A phase II study of tepotinib in patients with advanced solid cancers harboring MET exon 14 skipping mutations or amplification (KCSG AL19 -17)

Published date:
10/16/2023
Excerpt:
At a median follow-up of 19 months, the ORR was 57.6% for all patients, 52.2% for METex14, and 70% for MET amplification. Median PFS was 8 months (95% CI, 4.5-11.5) and median OS was 14 months (95% CI, 7.8-20.2) in all patients...Tepotinib demonstrated promising antitumor activity and manageable toxicity profiles in patients with various solid cancers harboring METex14 or amplification.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

A Phase II Study of Tepotinib in Advanced Solid Cancers with MET exon 14 Skipping Mutation or Amplification; Results of Non-small Cell Lung Cancer

Published date:
08/08/2023
Excerpt:
We conducted a phase 2, multicenter, single arm study evaluating tepotinib in patients with advanced or metastatic solid cancers who progressed after standard treatment, harboring either MET exon 14 skipping mutation or MET amplification (copy number gain ≥6) detected by tissue-based next generation sequencing (NGS)....Tepotinib showed a favorable antitumor activity in NSCLC patients with MET exon 14 skipping mutation or amplification.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Patients with EGFR mutant (m) MET-altered NSCLC receiving tepotinib with an EGFR tyrosine kinase inhibitor (TKI): A case series.

Published date:
05/25/2023
Excerpt:
Clinical benefit was reported in 18/21 (86%) pts with METamp (12 PR, 57%), in 5/5 with MET overexpression (2 PR), and 2/2 with MET exon 14 skipping (2 PR)….Tepotinib plus an EGFR TKI showed promising clinical activity in pts with MET-altered NSCLC who have progressed on a previous EGFR TKI, including those with several lines of prior treatment.
Secondary therapy:
EGFR inhibitor
DOI:
10.1200/JCO.2023.41.16_suppl.9070
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Tepotinib in patients (pts) with advanced non-small cell lung cancer (NSCLC) with MET amplification (METamp).

Published date:
05/19/2021
Excerpt:
Objective response rate (ORR) by IRC was 42% (10/24 pts) overall, 71% (5/7 pts) in 1L, 30% (3/10 pts) in 2L and 29% (2/7 pts) in 3L….In the first study of a MET inhibitor in NSCLC with METamp prospectively detected by liquid biopsy, tepotinib showed high and clinically meaningful activity, especially in 1L, and was generally well tolerated.
DOI:
10.1200/JCO.2021.39.15_suppl.9021
Trial ID:
Evidence Level:
Sensitive: D – Preclinical
Source:
Title:

1146 - Tepotinib treatment inhibits tumor growth and affects tumor permeability in an intracranial PDX model of MET-amplified NSCLC brain metastasis

Published date:
03/15/2023
Excerpt:
...we report a detailed analysis of the effects of high-dose tepotinib in preclinical models of MET-amplified NSCLC brain metastases….By D16, tumor measurements (±SD) in tepotinib-treated mice (5.5 ± 3.4 mm3) were approximately 20-fold smaller than those in control mice (109.3 ± 50.1 mm3)....These preclinical analyses of tepotinib treatment of MET-amplified NSCLC brain metastases provide new insights, considering the observed tumor regression...