Adverse reactions of Tepotinib

In theVISION trial, the primary safety population included 255 patients with NSCLC harboring MET exon 14 skipping alterations who received at least one dose of Tepotinib 450 mg once daily; the median treatment duration was 22 weeks. Forty-two percent of patients were exposed to tepotinib for at least 6 months, and 18% were exposed to tepotinib for at least 1 year. Fifty-three percent of patients experienced grade 3 or worse adverse reactions.

Serious adverse reactions occurred in 45% of patients, the most common being pleural effusion, pneumonia, edema, and dyspnea; fatal adverse reactions were pneumonia, liver failure, and dyspnea due to fluid overload. The patient permanently discontinued tepotinib due to adverse reactions including edema, pleural effusion, dyspnea, worsening general health, and pneumonia. The most common adverse reactions of any grade (incidence≥20%) were edema, fatigue, nausea, and diarrhea. In the safety population, the incidence of interstitial lung disease (ILD)/pneumonitis was 3.1%, and hepatotoxicity was also observed in VISION.

The original drug Tepotinib is already on the market in China, but it is not yet eligible for medical insurance. Tepotinib Original drug currently marketed overseas is relatively expensive, and the price of each box of 225mg*30 tablets may be around RMB 80,000 (the price may fluctuate due to exchange rates). There are already generic Tepotinib drugs produced in other countries. The ingredients of these generic drugs are basically the same as those of the original drug, but the price is relatively cheap. For example, the price of 225mg*60 tablets produced by a Laos pharmaceutical factory may be more than 8,000 yuan per box (the price may fluctuate due to exchange rates).