Tepotinib

An open-label phase II study (VISION [NCT02864992]) enrolled patients with MET exon 14-skipping variants. The trial included 152 patients who received tepotinib (500 mg orally once daily). MET status was determined centrally either via liquid biopsy (from circulating free DNA obtained from plasma; n = 66) or via tissue biopsy (n = 60). Twenty-seven patients had positive results from both methods. The primary end point was objective response.[55][Level of evidence C3]

An open-label phase II study (VISION [NCT02864992]) enrolled patients with MET exon 14-skipping variants. The trial included 152 patients who received tepotinib (500 mg orally once daily). MET status was determined centrally either via liquid biopsy (from circulating free DNA obtained from plasma; n = 66) or via tissue biopsy (n = 60). Twenty-seven patients had positive results from both methods. The primary end point was objective response.[55][Level of evidence C3]

Among the 99 patients who had been followed for at least 9 months (i.e., the efficacy population), the objective response rate as assessed by independent review was 46% (95% CI, 36%–57%), with a median DOR of 11.1 months (95% CI, 7.2 –NE). Response rates were similar in the liquid biopsy and tissue biopsy groups.

An open-label phase II study (VISION [NCT02864992]) enrolled patients with MET exon 14-skipping variants. The trial included 152 patients who received tepotinib (500 mg orally once daily). MET status was determined centrally either via liquid biopsy (from circulating free DNA obtained from plasma; n = 66) or via tissue biopsy (n = 60). Twenty-seven patients had positive results from both methods. The primary end point was objective response.[55][Level of evidence C3]

Responses were similar regardless of prior therapy.

An open-label phase II study (VISION [NCT02864992]) enrolled patients with MET exon 14-skipping variants. The trial included 152 patients who received tepotinib (500 mg orally once daily). MET status was determined centrally either via liquid biopsy (from circulating free DNA obtained from plasma; n = 66) or via tissue biopsy (n = 60). Twenty-seven patients had positive results from both methods. The primary end point was objective response.[55][Level of evidence C3]

Grade 3 or higher adverse events occurred in 28% of patients, including peripheral edema in 7% of patients. Adverse events led to therapy discontinuation in 11% of patients.