On February 3, 2021, the FDA accelerated the approval of tepotinib (Tepmetko; EMD Serono), an oral MET kinase inhibitor, for the treatment of patients with metastatic non–small-cell lung cancer (NSCLC) who harbor MET exon 14 skipping alterations.
“In recent years, the treatment of lung cancer has seen powerful progress in the understanding of the genetic mutations that lead to tumor growth, resistance, and progression,” Andrea Ferris, President and Chief Executive Officer, LUNGevity Foundation, Chicago, IL, said in a press release. “The availability of a new precision medicine for NSCLC with METex14 skipping alterations advances patient access to targeted treatment and underscores the importance of routine comprehensive biomarker testing for patients with this challenging cancer,” she added.
The approval of tepotinib was based on results of a multicenter, open-label, phase 2 trial of 152 patients with advanced or metastatic NSCLC with MET exon 14 skipping alterations. Patients in this trial received tepotinib 450 mg orally once daily until disease progression or unacceptable toxicity.
The main efficacy measures were overall response rate (ORR) and response duration. Results showed an ORR of 43% among the 69 treatment-naïve patients, with a median duration of response of 10.8 months. Among the 83 previously treated patients, the ORR was also 43% and the median duration of response was 11.1 months.
The most common (≥20%) adverse reactions were edema, fatigue, nausea, diarrhea, musculoskeletal pain, and dyspnea.
Serious adverse reactions were observed in 45% of patients treated with tepotinib. Serious adverse reactions occurring in >2% of patients included pleural effusion (7%), pneumonia (5%), edema (3.9%), dyspnea (3.9%), general health deterioration (3.5%), pulmonary embolism (2%), and musculoskeletal pain (2%).
The FDA granted tepotinib a priority review and orphan drug and breakthrough therapy designations.