June 23, 2021—Savolitinib was approved in China for treatment of patients with NSCLC with MET exon 14 skipping alterations whose disease has progressed following systemic treatment or who are unable to receive chemotherapy.
The National Medical Products Administration based its approval on a phase II trial of 70 patients with NSCLC that included a subgroup (35.7%) with pulmonary sarcomatoid carcinoma. Patients received a 600-mg dose of the TKI orally once-daily.
At a median follow-up of 17.6 months, savolitinib demonstrated an overall response rate (ORR) of 42.9% (95% CI: 31.1%, 55.3%) and a median PFS of 6.8 months (95% CI: 4.2, 9.6) in the overall trial population and a clinically meaningful PFS across subgroups. For patients with pulmonary sarcomatoid carcinoma, ORR was (40.0%; 95% CI: 21.1%, 61.3%), consistent with that of other patients with NSCLC (44.4%; 95% CI: 29.6%, 60.0%).
The most common adverse events included abnormal hepatic function and pyrexia, as well as toxicity-induced liver injury and drug hypersensitivity that led to discontinuation of treatment. One participant experienced a fatal, treatment-related case of tumor lysis syndrome.