FDA Grants Breakthrough Therapy Designation for Tepotinib In Patients With NSCLC


The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for the investigational precision cancer medicine tepotinib in patients with non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations.

Alterations of the MET signaling pathway are found in various cancer types, including 3-5% of individuals with NSCLC. MET mutations correlate with aggressive tumor behavior and poor clinical prognosis. (1-3)

About Tepotinib

Tepotinib is an oral MET kinase inhibitor that is designed to selectively inhibit the oncogenic signaling caused by MET (gene) alterations, including both MET exon 14 skipping alterations and MET amplifications, or MET protein overexpression. (4)

The Breakthrough Therapy Designation is based on data from the ongoing VISION clinical trial (NCT02864992), showing a 50% response rate and an overall response duration of 14 to 17 months in patients with metastatic NSCLC harboring MET exon 14 skipping alterations detected by liquid or tissue biopsy.

Tepotinib is also being investigated in the INSIGHT 2 study (NCT03940703) in combination with the tyrosine kinase inhibitor Tagrisso (osimertinib) in epidermal growth factor receptor (EGFR) mutated, MET amplified, locally advanced or metastatic NSCLC having acquired resistance to prior EGFR TKI.

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  1. Reungwetwattana T, et al. Lung Cancer 2017;103:27-37.
  2. Mo HN, et al. Chronic Dis Transl Med 2017; 3(3):148-153.
  3. Lutterbach B, et al. Cancer Res 2007;67:2081–8.
  4. Bladt, F, et al. Clin Cancer Res 2013;19:2941-2951.
  5. Paik P, et al. J Clin Oncol 2019;37: (suppl; abstr 9005).

Lung Cancer