China has conditionally approved savolitinib (Orpathys), an oral targeted MET inhibitor, for patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with MET amplification whose disease has progressed after at least two previous lines of treatment. It is the first selective MET inhibitor approved in China for this patient group.
The approval is based on a phase 2 clinical trial in which patients received 600 mg of savolitinib once daily. The drug achieved an objective response rate of 32.3%, while disease control rates ranged from 63.1% to 68.2%. Patients responded quickly, with a median time to response of 1.4 months. Responses lasted a median of 9.2 to 9.7 months. Median progression-free survival was 4.0 months, and median overall survival reached 6.9 months.
Savolitinib showed a manageable safety profile. Treatment-related side effects occurred in 92.3% of patients, with 35.4% experiencing severe side effects. About one-third of patients required dose interruptions or reductions, and 7.7% stopped treatment because of side effects. No treatment-related deaths were reported.