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Merck Announces FDA Breakthrough Therapy Designation for Investigational Therapy Tepotinib in Patients with Metastatic NSCLC with METex14 Skipping Alterations

Nachrichtenagentur: news aktuell
11.09.2019, 10:40  |  317   |   |   
- Investigational oral MET inhibitor has previously received
SAKIGAKE 'fast-track' regulatory designation in Japan

- MET exon 14 skipping alterations and MET amplifications are
present in 3-5% of non-small cell lung cancer patients and correlate
with poor prognosis

- The designation is based on data from the ongoing VISION study,
which showed preliminary clinical evidence for tepotinib in
metastatic NSCLC harboring METex14 skipping alterations

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Darmstadt, Germany (ots/PRNewswire) - Merck, a leading science and
technology company, today announced that the US Food and Drug
Administration (FDA) has granted Breakthrough Therapy Designation for
the investigational targeted therapy tepotinib* in patients with
metastatic non-small cell lung cancer (NSCLC) harboring MET exon 14
skipping alterations who progressed following platinum-based cancer

"Tepotinib was associated with robust objective responses with
durability that has not previously been seen in patients with
metastatic NSCLC harboring MET exon 14 skipping alterations, selected
by either tissue or liquid biopsy approaches," said Luciano Rossetti,
Global Head of Research & Development for the Biopharma business of
Merck. "This breakthrough therapy designation further underscores the
potential of tepotinib, and we aim to advance this program and
deliver this medicine as quickly as possible to NSCLC patients who
may benefit."

Lung cancer is the most common type of cancer worldwide, with 2
million cases diagnosed annually.[1] Alterations of the MET signaling
pathway are found in various cancer types, including 3-5% of NSCLC
cases, and correlate with aggressive tumor behavior and poor clinical

Discovered in-house at Merck, tepotinib is an investigational oral
MET kinase inhibitor that is designed to be highly potent and
selective[5] and to inhibit the oncogenic signaling caused by MET
(gene) alterations, including both MET exon 14 skipping alterations
and MET amplifications, or MET protein overexpression.

In March 2018, tepotinib's potential was recognized by the
Japanese Ministry of Health, Labour and Welfare (MHLW), which granted
SAKIGAKE 'fast-track' designation for tepotinib in advanced NSCLC
harboring MET exon 14 skipping alterations. SAKIGAKE designation
promotes research and development in Japan, aiming at early practical
application for innovative pharmaceutical products, medical devices
and regenerative medicines.

Tepotinib is also being investigated in the INSIGHT 2 study
(NCT03940703) in combination with the tyrosine kinase inhibitor (TKI)
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