Tepotinib Granted Traditional Approval for Metastatic Non–Small Cell Lung Cancer

The FDA has granted traditional approval to tepotinib (Tepmetko®, EMD Serono, Inc.) for adult patients with metastatic non–small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. Tepotinib was previously granted accelerated approval for this indication on February 3, 2021.  

Why it matters: “MET inhibitors have recently demonstrated clinical activity in patients with MET exon 14–skipping NSCLC; however, data with longer follow-up and in larger populations are needed to further optimize therapeutic approaches,” wrote Julien Mazieres, MD, PhD, a Professor of Medicine at the Claudius Regaud Institute University Hospital in Toulouse, France, and colleagues, in their published results of the VISION trial (NCT02864992), on which approval was based.

What they studied: Efficacy was evaluated in the phase 2, open-label, non-randomized, multicohort trial, in which 313 patients—164 treatment-naive and 149 previously treated—with metastatic NSCLC harboring MET exon skipping alterations were enrolled. Patients received 450 mg of tepotinib once daily until disease progression or unacceptable toxicity.

Initially, the accelerated approval was based on the overall response rate and duration of response results. The update to traditional approval was granted due to the results of an additional 161 patients and an added 28 months of follow-up to assess duration of response.

The primary end points remained overall response rate and duration of response determined by a blinded independent review committee.

What they found: Among those in the treatment-naive population, the overall response rate was seen at 57%, and 40% of those who responded had a duration of response ≥12 months. Among those in the previously treated population, the overall response rate was seen at 45%, and 36% of those who responded had a duration of response ≥12 months.

Adverse events: The most common adverse events experienced by ≥20% of patients receiving tepotinib were edema, nausea, fatigue, musculoskeletal pain, diarrhea, dyspnea, decreased appetite, and rash. 

Conclusion: “The long-term outcomes of VISION demonstrated robust and durable clinical activity following treatment with tepotinib, particularly in the treatment-naive setting, in the largest known clinical trial of patients with MET exon 14–skipping NSCLC, supporting the global approvals of tepotinib and enabling clinicians to implement this therapeutic approach for such patients,” concluded Dr. Mazieres and colleagues.

Instructions: The recommended dosage is 450 mg of tepotinib orally, once daily with food.

For More Information

Mazieres J, Paik PK, Garassino MC, et al (2023). Tepotinib treatment in patients with MET exon 14-skipping non-small cell lung cancer: long-term follow-up of the VISION phase 2 nonrandomized clinical trial. JAMA Oncol, 9(9):1260-1266. DOI:10.1001/jamaoncol.2023.1962

Clinicaltrials.gov (2023). Tepotinib phase II in NSCLC harboring MET alterations (VISION). NLM identifier: NCT02864992.

Tepmetko® (tepotinib) prescribing information (2024). EMD Serono Inc. Available at: https://www.emdserono.com/us-en/pi/tepmetko-pi.pdf

US Food and Drug Administration (2024). FDA approves tepotinib for metastatic non-small cell lung cancer. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tepotinib-metastatic-non-small-cell-lung-cancer

Image credit: Yale Rosen. Licensed under CC BY-SA 2.0

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