Tepmetko ( Tepotinib ) was granted accelerated approval by Food and Drug Administration for adult patients with metastatic non-small cell lung cancer ( NSCLC ) harboring mesenchymal-epithelial transition ( MET ) exon 14 skipping alterations.

Efficacy was demonstrated in the VISION, a multicenter, non-randomized, open-label, multicohort study enrolling 152 patients with advanced or metastatic non-small cell lung cancer with MET exon 14 skipping alterations.
Patients received Tepotinib 450 mg orally once daily until disease progression or unacceptable toxicity.

The main efficacy outcome measures were overall response rate ( ORR ) determined by a blinded independent review committee using RECIST 1.1 and response duration.
Among the 69 treatment naïve patients, the overall response rate was 43% ( 95% CI: 32%, 56% ) with a median response duration of 10.8 months ( 95% CI: 6.9, not-estimable ).
Among the 83 previously treated patients, the overall response rate was 43% ( 95% CI: 33%, 55% ) with a median response duration of 11.1 months ( 95% CI: 9.5, 18.5 ).

The most common adverse reactions ( greater than or equal to 20% of patients ) were edema, fatigue, nausea, diarrhea, musculoskeletal pain, and dyspnea. Tepotinib can also cause interstitial lung disease, hepatotoxicity, and embryo-fetal toxicity.

The recommended Tepotinib dose is 450 mg orally once daily with food.

This indication is approved under accelerated approval based on overall response rate and response duration. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. ( Xagena_2021 )

Source: FDA, 2021

Xagena_Medicine_2021