Pharmacist Medication Insights: Tepotinib for Non-Small Cell Lung Cancer
Earlier this year, the FDA granted accelerated approval to tepotinib (Tepmetko, EMD Serono Inc) for the treatment of adults with metastatic non-small cell lung cancer who are harboring MET exon 14 skipping alterations.
Tepotinib (Tepmetko, EMD Serono Inc) is indicated for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) who are harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
According to earlier research, MET exon 14 alterations cause increased MET protein levels because they disrupt ubiquitin-mediated degradation. They occur in approximately 3% of adenocarcinomas and approximately 2% in other lung neoplasms and are thus attractive potential targets for lung cancer treatment, according to an FDA press release.
The FDA granted the drug accelerated approval based on overall response rate and duration.
The efficacy of tepotinib was demonstrated in the VISION trial, which was a multicenter, non-randomized, open label, multicohort study with 152 patients who had advanced or metastatic NSCLC with MET exon 14 skipping alterations. The participants received tepotinib 450 mg orally once daily until either disease progression or unacceptable toxicity.
The main outcome measures were overall response rate (ORR) and response duration. According to a press release, the 69 treatment-naïve patients had an ORR of 43% with a median response duration of 10.8 months. Among 83 previously treated patients, the ORR was 43% with a median response duration of 11.1 months.