The FDA transitioned the small-molecule inhibitor tepotinib (Tepmetko) from accelerated to full approval for metastatic non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations.
The action occurred after enrollment of more patients in a nonrandomized, open-label, multicohort study and additional follow up to assess duration of response. The agency granted accelerated approval of tepotinib in 2021.
Support for accelerated approval came from the multicenter VISION trial, which initially enrolled 151 patients with NSCLC and MET exon 14 skipping mutations. The trial had primary efficacy endpoints of objective response rate (ORR) and duration of response. The primary analysis showed an ORR of 46% in 99 patients followed for at least 9 months.
Full approval came after investigators enrolled another 161 patients and accrued an additional 28 months of follow-up. An updated analysis showed an ORR of 57% in 164 previously untreated patients, with 40% of responses lasting at least 12 months. Among 149 previously treated patients, single-agent tepotinib led to an ORR of 45%, with 36% of responses lasting 12 months or more.
Adverse events occurring in at least 20% of patients included edema, nausea, fatigue, musculoskeletal pain, diarrhea, dyspnea, decreased appetite, and rash. The drug is administered once daily with food.
Tepotinib is one of two MET inhibitors approved for NSCLC with exon 14 skipping alterations, the other being capmatinib (Tabrecta).
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