FDA grants Merck MET inhibitor tepotinib breakthrough therapy designation
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Last Update: 2020-06-08
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Source: Internet
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Author: User
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Today, Merck KGaA announced that the U.SFDA(http://granted its MET inhibitor tepotinib breakthrough therapy to treat mettostatic non-small cell lung cancer (NSCLC) patients with MET exmetro 14 jump mutationsAbout Tepotinib
Tepotinib is a highly selective oral MET inhibitor developed by Merck, Germany, that shows antitumor activity in patients with Met overexpression or amplification of NSCLCIn addition to being used in clinicaltrial(http://for treatment of Patients with NSCLC, tepotinib is also treated in Phase 2 clinical trials for patients with hepatocellular carcinomaThe breakthrough therapy is based on a Phase 2 clinical study called VISION, which is currently under wayA total of 73 patients with metastatic NSCLC with met met exon 14 jump mutations were involved in the trial, identified by tissue biopsy (TBx) or liquid biopsy (LBx)Trial data suggest that tepotinib may improve treatment choices in these patientsFor patients identified by LBx, the Total Mitigation Rate (ORR) obtained by the Independent Review Board (IRC) was 50% and the researchers' results were 55.3%For patients identified with TBx, the two figures were 45.1% and 54.9%, respectivelyIn terms of median mitigation duration (DOR), the IRC gave 12.4 months and 15.7 months, respectively, for patients identified by LBx and TBx For both groups of patients, the researchers gave 17.1 months and 14.3 months, respectively
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