Drug updated on 10/25/2024
Dosage Form | Tablet (oral; 225 mg) |
Drug Class | Kinase inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
Latest News
Summary
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- Tepotinib demonstrated an objective response rate (ORR) of 44.7% and a disease control rate (DCR) of 69.1% in patients with MET (METex14)-altered non-small cell lung cancer (NSCLC). In specific subgroups, patients with MET exon 14 skipping showed an ORR of 39.3%, and those with intracranial disease had an intracranial response rate of 40.1%.
- Comparative Effectiveness: Tepotinib had a higher ORR (44.7%) compared to other MET inhibitors with a pooled ORR of 28.1%. Targeted MET tyrosine kinase inhibitors (TKIs), including tepotinib, showed superior efficacy (ORR of 50.7%-68.8%) compared to chemotherapy (23.1%-27.0%) and immunotherapy (33.3%) in METex14 skipping NSCLC.
- Subgroup Considerations: Tepotinib was particularly effective in NSCLC patients with exon 14 skipping and those with intracranial metastases, offering higher response rates and disease control compared to other therapies, making it a preferred option in these genetic subgroups.
- In patients treated with tepotinib, 87.2% experienced mild adverse events (grade 1 to 2). The most common grade 3 or higher adverse events were lower extremity edema (3.5%), alanine aminotransferase (ALT) elevation (2.4%), and lipase elevation (2.2%).
- The safety profile of tepotinib, when compared with other MET inhibitors, was favorable, with mostly mild adverse events and a low incidence of severe adverse reactions. There were no significant safety concerns highlighted for specific populations or subgroups.
- These findings are clinically relevant, especially in elderly patients, who are more likely to have MET exon 14 skipping mutations, and in histological subtypes like sarcomatoid (12% frequency of MET exon 14 skipping).
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Tepmetko (tepotinib) Prescribing Information. | 2024 | EMD Serono, Inc., Rockland, MA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Non-small cell lung cancer with MET amplification: review of epidemiology, associated disease characteristics, testing procedures, burden, and treatments | 2023 | Frontiers in Oncology |
MET Exon 14 Skipping in NSCLC: A Systematic Literature Review of Epidemiology, Clinical Characteristics, and Outcomes | 2023 | Clinical Lung Cancer |
MET-targeted therapies for the treatment of non-small-cell lung cancer: A systematic review and meta-analysis | 2022 | Frontiers in Oncology |
MET-Targeted Therapies and Clinical Outcomes: A Systematic Literature Review | 2022 | Molecular Diagnosis & Therapy |