Recently, the British Medicines and Health Products Administration (MHRA) published a report on Merck’s targeted anticancer drug Teppetko (tepotinib) for the treatment of advanced non-small cell lung cancer (NSCLC) patients with MET gene exon 14 skipping (METex14 skipping) Received positive scientific opinions.

MHRA’s positive review opinions have been issued through MHRA’s Early Access to Medicines Program (EAMS). The plan aims to enable a group of patients with serious illnesses with significant unmet medical needs to obtain drugs that have not yet been approved for marketing in the UK.

NSCLC is the most common type of lung cancer, accounting for 80-85% of lung cancer diagnosed cases. In these cases, METex14 changes occur in approximately 3-4% of patients, which has a worse clinical prognosis compared with other types of NSCLC.

Tepmetko is a highly selective MET inhibitor that is taken orally once a day. The drug was the first to be approved in Japan in March 2020, becoming the world's first oral MET inhibitor approved for the treatment of advanced NSCLC patients with MET genetic changes. In February of this year, Teppetko was also approved by the US FDA.

MHRA approved the scientific opinion on Tepmetko based on the results of the Phase II trial of the VISION study. The study was carried out in patients with advanced or metastatic NSCLC who carried METex14 skip changes, and evaluated the efficacy and safety of Teppetko as a monotherapy. In this study, after independent evaluation of the combined biopsy group (liquid biopsy + tissue biopsy), the objective response rate (ORR) of Teppetko treatment reached 46%.