FDA Approves Tepotinib in NSCLC With MET Exon 14 Mutation
Results from the phase 2 VISION trial have allowed for tepotinib to receive full approval by the FDA in non–small cell lung cancer harboring MET exon 14 skipping alterations.
Data from the phase 2 VISION study (NCT02864992) supported the FDA approval of tepotinib in non–small cell lung cancer harboring MET exon 14 skipping alterations.
The FDA has approved tepotinib for patients with non–small cell lung cancer (NSCLC) who have MET exon 14 skipping alterations, according to a press release from the agency.1
The approval is based on results from the phase 2 VISION trial (NCT02864992) evaluating the agent in the aforementioned population.2 The agent previously received accelerated approval in February 2021; the full approval is based on the evaluation of 161 additional patients with 28 extra months of follow-up in the VISION trial.
Efficacy for the trial was evaluated in 313 patients who were given 450 mg of tepotinib once daily until patients had disease progression or unacceptable toxicity. In 164 patients who did not receive prior treatment, the overall response rate (ORR) was 57% (95% CI, 49%-65%), and 40% of patients had a duration of response (DOR) of 12 months or more. Of 149 patients who were previously treated, the ORR was 45% (95% CI, 37%-53%), and 36% of patients had a DOR of 12 months or more.
Common adverse effects observed in 20% or more of patients included edema, nausea, fatigue, musculoskeletal pain, diarrhea, dyspnea, decreased appetite, and rash.
The approval mentions the recommended dose of tepotinib being 450 mg orally once daily with food.
References
- FDA approves tepotinib for metastatic non-small cell lung cancer. News release. FDA. February 15, 2024. Accessed February 15, 2024. https://bit.ly/3SJD4Wl
- Paik PK, Felip E, Veillon R, et al. Tepotinib in non-small-cell lung cancer with MET exon 14 skipping mutations. N Engl J Med. doi:10.1056/NEJMoa2004407.
