Merck ensures breakthrough therapy designation for its NSCLC tepotinib

Merck has ensured Breakthrough Therapy Designation for the investigational targeted therapy tepotinib in USA, for patients with metastatic non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations who progressed following platinum-based cancer therapy.

“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 KGaA, Darmstadt, Germany. “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 prognosis.^2-4 

Discovered in-house at Merck KGaA, Darmstadt, Germany, tepotinib is an investigational oral MET kinase inhibitor that is designed to be highly potent and selective⁵ 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.