Tepotinib (1) – Tepmetko®

• Clinical trials
  • To demonstrate the additional benefit of tepotinib for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with a METex14 skipping mutation who require systemic therapy following platinum-based chemotherapy and/or immunotherapy, the pharmaceutical manufacturer presents results from the ongoing open-label, two-part, uncontrolled, multicentre Phase II VISION trial.
  • These two studies are retrospective, non-interventional studies conducted by the pharmaceutical manufacturer, based on electronic health records from oncology practices in the USA (Study 0015) and patient records from several oncology centres (Study 0035).

a) Adults with advanced non-small cell lung cancer (NSCLC) with MET tyrosine kinase receptor exon 14 (METex14)skipping alterations following first-line treatment with a PD-1/PD-L1 antibody as monotherapy

• An additional benefit is not proven.

b) Adults with advanced non-small cell lung cancer (NSCLC) with MET tyrosine kinase receptor exon 14 (METex14-) skipping mutations following first-line treatment with platinum-based chemotherapy

• The additional benefit is not proven.

c) Adults with advanced non-small cell lung cancer (NSCLC) with MET tyrosine kinase receptor exon 14 (METex14)skipping alterations following first-line treatment with a PD-1/PD-L1 antibody in combination with platinum-based chemotherapy or following sequential treatment with a PD-1/PD-L1 antibody and platinum-based chemotherapy

• The additional benefit is not proven.
• Overall assessment
  • The analyses submitted by the pharmaceutical manufacturer consist of a purely descriptive comparison of individual endpoints from various studies.
  • The results of the single-arm VISION study submitted on their own are not suitable for assessing the additional benefit of tepotinib, as they do not allow for a comparison with the appropriate comparator therapy.
  • Overall, the data submitted are not suitable for assessing additional benefit; consequently, additional benefit of tepotinib over the appropriate comparator therapy is not proven.

Courtesy translation only, please refer to the German original.