Tepotinib Approved by European Commission for Advanced MET exon 14+ NSCLC

Tepotinib (Tepmetko) received approval from the European Commission for patients with advanced non–small cell lung cancer (NSCLC) with MET exon 14 skipping alterations who need systemic therapy after previous immunotherapy and/or platinum-based chemotherapy, according to a press release from Merck.¹

The decision was based on findings from the pivotal phase 2 VISION study (NCT02864992), which assessed the agent alone in patients with advanced NSCLC with MET exon 14 skipping alterations.² In the population of 152 patients, treatment with tepotinib resulted in a response rate of 46% and a median duration of response of 11.1 months by independent review in the overall population.2 Additionally, responses of 48% and 50% were observed in the liquid (n = 66) and tissue (n = 60) biopsy cohorts, respectively.

“The approval of [tepotinib] provides a much-needed targeted treatment option for patients with advanced [NSCLC] with MET exon 14 skipping alterations,” investigator Egbert Smit, MD, PhD, a professor of pulmonary medicine in the Department of Thoracic Oncology at the Netherlands Cancer Institute and at Department of Pulmonary Diseases at Vrije Universiteit Medical Centre, said in a press release. “[Tepotinib] has demonstrated durable and consistent response rates and has the potential to help patients with this challenging cancer.”

Accelerated approval was granted to tepotinib by the FDA for patients with metastatic NSCLC and MET exon 14 skipping alterations in February 2021.

References

1. European Commission approves Tepmetko (tepotinib) for patients with advanced NSCLC with METex14 skipping alterations. News release. Merck. February 18, 2022. Accessed February 18, 2022. https://bwnews.pr/3uX3hpR
2. Paik PK, Felip E, Veillon R, et al. Tepotinib in non–small-cell lung cancer with MET Exon 14 skipping mutations. N Engl J Med. 2020;383:931-943. doi:10.1056/NEJMoa2004407