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Merck KGaA's Tepmetko Approved in Europe for NSCLC With MET Exon 14 Alterations

NEW YORK – The European Commission on Friday approved Merck KGaA's Tepmetko (tepotinib) for patients with previously treated, advanced non-small cell lung cancer harboring MET exon 14 skipping alterations.

The approval will make Tepmetko available to patients in Europe who require systemic therapy following prior treatment with immunotherapy or platinum-based chemotherapy, a departure from the drug's other regulatory approvals that allow use in patients across different lines of treatment.

The approval was based on data from the Phase II VISION trial. Among 99 evaluable patients with at least nine months of follow-up, the objective response rate was 46 percent, and the median duration of response was 11.1 months. The researchers noted that responses were similar across treatment lines, including treatment-naïve patients and patients who had received prior chemotherapy or immunotherapy.

Last year, Tepmetko was granted accelerated approval in the US for metastatic non-small cell lung cancer patients whose tumors harbor MET exon 14 skipping alterations. The drug was also approved in Japan in 2020 for the same indication, along with ArcherDx's ArcherMET test as a companion diagnostic to identify patients eligible for treatment. Both the US and Japan approvals were for metastatic NSCLC patients with MET exon 14 skipping alterations, regardless of whether they were previously treated or not. The EC and US approvals did not specify a companion diagnostic to select patients for treatment.

In China and Japan, Merck KGaA has partnered with diagnostics firms to develop companion diagnostics for Tepmetko. Along with ArcherDx, the company is also collaborating with Amoy Diagnostics to develop a diagnostic in Japan. In November, Merck KGaA and Burning Rock Biotech entered into a partnership to develop a diagnostic for Tepmetko in China.

Merck KGaA is also exploring Tepmetko in combination with AstraZeneca's Tagrisso (osimertinib) in a Phase II study in patients with EGFR-mutated, MET amplified, locally advanced or metastatic NSCLC that is resistant to EGFR inhibitors.