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

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

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  • 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

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Ref: GlobeNewswire | Image: Merck KGaA


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