FDA grants regular approval for Tepmetko (tepotinib) for metastatic NSCLC harboring MET exon 14 skipping alterations

In February 2021, the regulatory agency granted accelerated approval to the MET inhibitor for this indication based on findings from the phase II VISION trial (NCT02864992). Tepotinib induced an objective response rate (ORR) of 43% (95% CI, 32%-56%) in 69 treatment-naive patients per blinded independent review committee (BIRC) and RECIST v1.1 criteria. The median duration of response (DOR) was 10.8 months (95% CI, 6.9-not estimable). In 83 previously treated patients, the ORR was also 43% (95% CI, 33%-55%) with a median DOR of 11.1 months (95% CI, 9.5-18.5).

The decision to convert the accelerated approval to a traditional approval was based on data from an additional 161 patients with 28 months of added follow-up time for DOR. Findings indicated that in evaluable treatment-naive patients (n = 164), tepotinib elicited an objective response rate (ORR) of 57% (95% CI, 49%-65%). Forty percent of responders continued to respond for 12 months or longer. In evaluable previously treated patients (n = 149), the ORR achieved with the agent was 45% (95% CI, 37%-53%), with 36% of responders experiencing a DOR of at least 12 months.