HUTCHMED (China) Limited announced that the supplemental New Drug Application (sNDA) for savolitinib has been accepted for review by the China National Medical Products Administration (NMPA). This application seeks to expand the use of savolitinib to include treatment-naive adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) exhibiting mesenchymal epithelial transition factor (MET) exon 14 skipping alterations. Savolitinib, marketed under the brand name ORPATHYS® in China, was previously granted conditional approval for patients who have progressed following prior systemic therapy or are unable to receive chemotherapy.
Data from the confirmatory Phase IIIb clinical trial, presented at the European Lung Cancer Congress, demonstrated promising efficacy and safety profiles for savolitinib. In treatment-naive patients, the objective response rate (ORR) was 62.1%, with a disease control rate (DCR) of 92.0% and a median duration of response (DoR) of 12.5 months. The median progression-free survival (PFS) was 13.7 months, and the median overall survival (OS) was not reached with a median follow-up of 20.8 months. For previously treated patients, the ORR was 39.2%, DCR was 92.4%, and median DoR was 11.1 months, with a median PFS of 11.0 months.
Savolitinib is an oral, potent, and highly selective MET tyrosine kinase inhibitor that targets the atypical activation of the MET receptor tyrosine kinase pathway due to mutations, gene amplification, or protein overexpression. It represents the first selective MET inhibitor approved in China, addressing a significant unmet need given that more than a third of the world’s lung cancer patients are in China, with approximately 2-3% of NSCLC patients globally having tumors with MET exon 14 skipping alterations.
The safety profile of savolitinib was found to be tolerable, with the most common drug-related treatment-emergent adverse events of Grade 3 or above including abnormal hepatic function, increased alanine aminotransferase, increased aspartate aminotransferase, peripheral edema, and increased gamma-glutamyltransferase. No new safety signals were observed.
This development underscores the potential of savolitinib as a targeted treatment option for NSCLC patients with MET exon 14 skipping alterations, both treatment-naive and previously treated, offering hope for improved outcomes in this patient population.
