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June 1, 2020 /
Bio-Valley
BIOON /-- According to a new study published in New England Journal of Medicine, the objective response rate of late-stage non-small cell lung cancer (NSCLC) patients with met exoskeleton 14 (METex14) jump mutation to tepotinib treatment is 46.5 percentThe study was carried out by researchers at the University of Texas' MD Anderson Cancer Center" success in this trial and other similar drug studies suggests that METex14 is an active target for non-small cell lung cancer"The study's senior author, Xiuning Le, M.D., an assistant professor of oncologyin chest/head and neck"We are pleased to show that another group of lung cancer patients may benefit from precision medicine"
METex14 gene jump mutation is a mutation that drives cancer growth and has a 3-4% chance of occurring in NSCLC patientsPatients with METex14 gene mutations tend to be older, with a median age of 74, and there are usually no other actionable gene mutations and no targeted treatment options availablethe results represent group A of the single-arm International PHASE II VISION trial, which is still in progress, as well as other groupsMore than 6,700 non-small cell lung cancer patients were preselected for MET mutations through liquid and/or tissue biopsiesTepotinib was treated with 152 patients with non-small cell lung cancer with advanced METex14 gene mutationsPatients who have been treated and/or have stable brain metastasis can participate in the trialParticipants took 500 mg of tepotinib orally daily image source: NIH benefits that are meaningful to older people
the primary endpoint is objective response rate, defined as a full or partial response according to the RECIST v1.1 standard, and confirmed by an independent review After 9 months of follow-up, the objective validity rate of the main therapeutic population with 99 patients was 46.5%, and the sustained validity rate was 11.1 months "The average response time over the past year is very meaningful for this patient population," Said In addition to traditional chemotherapy, it is important for these elderly patients to have another treatment option, which can improve their quality of life over a long period of time "
toxic side effects were controllable, with 27.6% of patients reporting a level 3 treatment-related adverse event The most common side effect is peripheral edema Eleven percent of patients stopped treatment due to adverse events the study also collected patient reports showing an improvement in coughing and maintaining an overall quality of life liquid biopsies are used to biomarkers
detection
VISION studies show that liquid biopsies are a reliable method for detecting mutations The study also showed that liquid biopsies are a useful tool for identifying reactions to drugs 51 patients were given a baseline and pre-treatment matching liquid biopsy samples Next-generation sequencing found that 34 of these patients had molecular reactions, characterized by mutations or significant reductions, and ray imaging confirmed molecular responses in 68 percent of patients "This study marks a significant advance, and we now have an effective oral therapy for patients with non-small cell lung cancer who have no previous targeted treatment options," co-author John Heymach said "We are proud to lead this area forward by providing new treatments for our patients "
Tepotinib was awarded breakthrough therapy by the U.S Food and Drug Administration (
FDA ) in September 2019, based on early data from the VISION study In March 2020, the first oral targeted treatment of MET-positive NSCLC was approved for use in Japan (BioValleyBioon.com) Reference: Targeted with tepotinib for non-small cell lung with MET exon 14 skipping mutation show show end-
Paul K Paik et al.
Tepotinib in Non-Small-Cell Lung With MET Exon 14 Skipping Mutations New England Journal of Medicine DOI: 10.1056/NEJMoa2004407