The first domestic MET inhibitor "Volitini" listing application was sponsored by CDE.

This application for a new drug is based on an open-label Phase II Registration Data Support (NCT02897479).
the latest data, presented at the 2020 ASCO Conference, included 70 cases of MET14-mutant non-small cell lung cancer, of which 57.1% were lung adenocarcinoma, up to 35.7% were lung sarcoma -like cancer (PSC), and up to 22% combined with brain metastasis.
phase, 92.9% of patients were in stage IV and 60% were treated.
all patients are treated with volitinib (600 mg (50 kg or more);
the main research endpoint is ORR.
results showed that in 61 patients with an evaluative efficacy, the overall effectiveness rate was 47.5% and the disease control rate was 93.4%.
median PFS is 6.8 months (first in a combined high proportion of PSC patients, the overall PFS is more than half a year). the most common adverse reactions
included peripheral edema, nausea, elevated AST/ALT levels, vomiting, and low proteinuria.
the met14 exoon jump mutation in the abnormal lyson-driven gene of lung cancer, the incidence rate in lung adenocarcinoma is 3% to 4%, MET gene mutation is the cause of drug resistance in many tumors, usually met14 exoon jump mutation of lung cancer patients with poor prognosis.
patients carrying this mutation are insensitive to chemotherapy and treatment is not ideal.
and lung sarcoma-like cancer (PSC) is a rare type of lung cancer with a very poor prognosis, psC is more prone to invasion and metastasis than other NSCLCs, and met Exon14 plus in PSC can be as high as 31.8 percent, the emergence of Volitinib brings new hope to such patients, we hope that the drug can be approved early, for this type of patient syllitas.
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