indication
Used for the treatment of locally advanced or metastatic non-small cell lung cancer patients with MET exon 14 jump mutation positivity
effectiveness
On June 22, 2021, the National Medical Products Administration (NMPA) of China announced the approval of the marketing application for Savotinib (formerly known as Waritinib) for the treatment of locally advanced or metastatic non-small cell lung cancer patients with MET exon 14 jump mutation positivity.
The approval of Savotinib for market is of great significance. It is the first MET inhibitor in China and the first domestically produced targeted drug for treating cancer with MET exon 14 jump mutation.
The MET exon 14 jump mutation is a type of gene mutation in lung cancer patients, with a prevalence of 2% to 3% in non-small cell lung cancer patients in China. Cancer patients carrying MET-14 mutations generally have poor prognosis, and there is an urgent need for targeted drugs specifically targeting this mutation. Capmatinib and Tepotinib from abroad are used to treat non-small cell lung cancer with MET exon 14 jump mutation, but they have not yet been approved for marketing in China. The launch of the domestically produced targeted drug Savotinib fills this gap and provides drugs for domestic patients.
The efficacy of sevotinib in the treatment of MET-14 mutant lung cancer
The latest clinical trial results show that in the treatment of 70 patients with advanced lung cancer carrying MET exon 14 skipping mutations, the objective response rate (tumor shrinkage of over 30%) was 42.9%, the disease control rate was 82.9%, and the median response duration was 8.3 months. Among them, 7 patients (10%) had a response duration of at least 12 months.
The median progression free survival (PFS) of patients was 6.8 months, with progression free survival rates of 52% and 31.9% at 6 and 12 months, respectively. The median overall survival (OS) was 12.5 months.
From the clinical trial results, it can be seen that sevotinib has significant therapeutic effects on advanced lung cancer carrying MET exon 14 jump mutations.
What are the common side effects and adverse reactions of sevotinib? In clinical trials, most patients experience side effects of 1-2 grades after using sevotinib, mainly including nausea, elevated transaminase levels, edema, vomiting, etc. The incidence of grade 3 or above side effects is 31.7%, which is within a controllable range.
The cancer that can be treated with Savotinib is not only lung cancer. Currently, the global development of Savotinib has covered various solid tumors with MET abnormal mutations, including lung cancer, kidney cancer, gastric cancer, colorectal cancer, etc. Looking forward to the approval of more indications for Savotinib, benefiting more cancer patients.