Merck KGaA’s Tepotinib Receives FDA’s Breakthrough Therapy Designation for Metastatic NSCLC with METex14 Skipping Alterations

Merck KGaA’s Tepotinib Receives FDA’s Breakthrough Therapy Designation for Metastatic NSCLC with METex14 Skipping Alterations

Shots:

  • The BT designation is based on ongoing VISION study (NCT02864992) assessing Tepotinib in 73 patients with m-NSCLC harboring MET exon 14 skipping alterations detected by liquid biopsy (LBx) or tissue biopsy (TBx) across different lines of treatment
  • The VISION study results: ORR and DOR for LBx identified patients assessed by IRC & investigator (50% & 55.30% and 12.4 & 17.1 mos.); ORR and DOR for TBx identified patients (45.1% & 54.9% and 15.7 & 14.3) respectively
  • Tepotinib is an investigational oral MET inhibitor, also being investigated in the INSIGHT 2 study (NCT03940703) in combination with Osimertinib in EGFR mutated, MET amplified, LA/m-NSCLC having acquired resistance to prior EGFR TKI and has received MHLW’s Sakigake designation in Mar’2018

Click here to­ read full press release/ article | Ref: GlobeNewswire | Image: Glassdoor