European regulators will review Merck's tepotinib for a specific type of lung cancer, having validated the drug's marketing application.
Tepotinib is designed to treat advanced non-small cell lung cancer (NSCLC) in adults harbouring mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations.
The drug is a highly selective oral MET inhibitor administered once daily, which has shown promise in the pivotal Phase II VISION study. In the study, the primary endpoint was the objective response by independent review among patients with at least nine months' follow-up.
The response was also analysed via liquid or tissue biopsy to determine whether MET exon 14 skipping mutations were present.
Of 99 patients who had been followed for at least nine months, the response rate by independent review was 46%, with a median duration of response of 11.1 months in the combined-biopsy group.
The response rate was found to be 48% among 66 patients in the liquid-biopsy group and 50% among 60 patients in the tissue-biopsy group, and 27 patients had positive results according to both methods.
As Merck notes, METex14 skipping occurs in approximately 3-4% of NSCLC cases and is linked with aggressive tumour behaviour and poor clinical prognosis.
Currently, there are no treatments available in Europe for patients with this type of NSCLC, highlighting significant unmet need.