Key findings from Novaral Tabrecta's treatment of patients with METex14 mutations have been published.

Introduction: The New England Journal of Medicine (NEJM) published positive results from a key Phase 2 clinical study of NOVAR Tabrecta (formerly KNOWN280).
September 2nd, the New England Journal of Medicine (NEJM) published positive results from NOVAR Tabrecta (formerly KNOWN280) critical Phase 2 clinical study GEOMETRY mono-1.
data show that Tabrecta's total response rate (ORR) was positive in adult patients with metastasis non-small cell lung cancer (NSCLC) mutations in the treatment of MET exon 14 jump (METex14) and positive for remission duration (DOR).
a multi-queue Phase 2 clinical study that assessed the role of capmatinib in patients with late-stage NSCLC with MET regulatory disorders, in a total of 364 patients.
group patients based on previous treatment routes and patient MET status (METex14 mutations or MET amplification based on the number of copies of genes in tumor tissue).
patients take capmatinib (400 mg tablets) twice daily.
the main endpoint of the study was the overall response (OR, including full or partial mitigation);
the latest data published in these studies include the confirmation by the Independent Radiology Commission (BIRC) of the efficacy of capmatinib treatment in patients with the METex14 mutation (n=97): ORR was 68% (95% CI, 48-84) of patients who had been treated (n=28) and or in patients who had previously received first- or second-line treatment (n=69) R was 41% (95% CI, 29-53); 5.6-unestimated); in patients who had been treated in the past (28 respondents), the medium DOR was 9.7 months (95%CI, 5.6-13.0).
for patients who had previously received treatment, MET amplification, and gene copies of less than 10, capmatinib had limited efficacy, with AN of 7%-12%.
For patients with MET amplification and gene copy numbers of 10 or higher: OR was 29% (95% CI, 19-41) in patients who had previously been treated, and 40% (95% CI, 16-68) in patients who had not been treated in the past.
13 of the 14 METex14 mutation patients in the trial had brain metastasis during baseline tests (3 were untreated and 10 had been treated).
post-mortem analysis, seven patients were observed to have intracranial reactions, including four complete reactions.
addition, the most common treatment-related adverse events in capmatinib (the occurrence rate was 20%): exostular edema (43%), nausea (34%), elevation of blood creatinine (18%) and vomiting (19%).
most adverse events are level 1 or 2.
results showed significant anti-tumor activity in patients with advanced NSCLC mutation METex14, especially in those who were not treated.
in patients with met amplification late NSCLC, capmatinib was more effective for tumors with high gene copies than tumors with low gene copies.
, the study adds to the scientific consensus that METex14 is a carcinogenic driver.
to determine the presence of METex14 is a viable option for patients with metastatic lung cancer, the study also highlights the importance of wide molecular testing in NSCLC patients.
NSCLC accounts for about 85% of the 2 million new lung cancer patients diagnosed worldwide each year.
nearly 70 percent of NSCLC patients carry genomic mutations.
met is a tyrosine kinase encoded by the MET gene, which usually plays an important role in cell signaling, proliferation and survival.
many cancers are associated with abnormal signals in the MET subject pathway, which are caused by a variety of mechanisms, including point mutations, insertions/absences that cause 144 exons to skip.
until recently, there were obstacles to effective targeting of mets, one of which was to determine the best biomarker.
METex14 is a recognized carcinogenic driver, and about 3% to 4% of newly diagnosed patients with advanced NSCLC are found to carry the gene mutation.
the emergence of drugs such as Tabrecta, which allowed METex14 to become a predictive biomarker for MET-directed therapy.
the active pharmaceutical ingredient of capmatinib chemical structure Tabrecta is capmatinib, an oral, powerful, selective MET inhibitor licensed by Novartic from Incyte in 2009.
May, the drug was approved by the FDA as the first treatment for metastasis NSCLC adult patients with METex14 mutations.
source: 1. Novartis announces NEJM publication of pivotal study of Tabrecta in patients with METex14 metastatic non-small cell lung cancer2. Capmatinib in MET Exon 14-Mutate or MET-Amplified Non-Small-Cell Lung Cancer.