TKI - September 2020

TKI - September 2020

FDA accepted filing of new drug application for Tepotinib for the treatment of patients with metastatic NSCLC with METex14 skipping alterations

25 Aug 2020

Tepotinib (c-Met kinase inhibitor) – EMD Serono, US subsidiary of Merck KGaA

  • FDA granted Priority Review to the new drug application (NDA) for once-daily, oral tepotinib for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition exon 14 (METex14) skipping
  • The application is based on results from the pivotal ongoing, single-arm Phase 2 VISION study evaluating tepotinib as monotherapy in patients with advanced NSCLC with MET exon 14 (METex14) skipping alterations prospectively assessed by liquid and/or tissue biopsy
  • Results demonstrate consistent response rate and durable anti-tumor activity across lines of treatment (including patients with brain metastases) assessed by both liquid biopsy and tissue biopsy
  • Data from the initial analysis of the VISION study were published in The New England Journal of Medicine on May 29, 2020 and presented at ASCO 2020

FDA granted priority review for tepotinib in metastatic NSCLC with METex14 skipping alterations

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CI Scientists Remarks: 

  • In Mar’20, tepotinib was approved in Japan for advanced NSCLC harboring MET gene alterations
  • In Sep’19, FDA granted Breakthrough Therapy Designation for tepotinib in patients with metastatic NSCLC harboring METex14 skipping alterations whose disease progressed following platinum-based cancer therapy
  • Tepotinib in METex14 mutation NSCLC is “line-agnostic”

Other products in the same class

  • Capmatinib (Novartis) approved in May’20 – had superior overall response (68% in treatment-naive & 41% in previously-treated patients) compared to tepotinib (45% to 50% in all patients)
  • To further expand in NSCLC, Merck KGaA is also evaluating tepotinib in a Phase 2 INSIGHT 2 study in combination with osimertinib in MET amplified, advanced or metastatic NSCLC harboring activating EGFR mutations that has progressed following first-line treatment with osimertinib

– Dr. Kowndinya, CI Scientists

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