▎WuXi AppTec Content Team Report

Today (June 12), Novartis announced that the marketing application for capmatinib tablets has been officially accepted.Approved by the National Medical Products Administration (NMPA) of China，For untreated patients with mesenchymal-epithelial transition factor (MET) exon 14 skipping mutation（METex14Mutation)Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)。

Capmatinib Hydrochloride Tablets are aHigh oral bioavailability, highly selective specific MET receptor tyrosine kinase inhibitor, effectively inhibits the phosphorylation of MET and MET-mediated downstream signaling proteins., thereby inhibiting the proliferation and migration of tumor cells and effectively inducing apoptosis, demonstrating anti-tumor activity. The drug was initially discovered by Incyte, and Novartis obtained its R&D and marketing license in 2009. According to an earlier press release from Novartis, capmatinib is the first FDA-approved treatment forMETex14Targeted drugs for metastatic NSCLC with leap mutations. Previously, the product has been approved for marketing in countries and regions such as the United States, Japan, and the European Union.

Support for Capmatinib Hydrochloride TabletsThe clinical research data approved in China isGlobal Multicenter Clinical StudyGeoMETry mono-1 andRegistration Clinical Study Targeting the Chinese PopulationGeoMETry-C。

The GeoMETry mono-1 study showed that, according to the assessment by the Blinded Independent Review Committee,Capmatinib in the treatmentTherapy METex14The objective response rate (ORR) and disease control rate (DCR) in treatment-naïve patients with advanced non-small cell lung cancer harboring jumping mutations were 68.3% and 98.3%, respectively., with a median overall survival (OS) of 25.5 months。

The Chinese GeoMETry-C clinical study showed that, as of the data cutoff date of November 30, 2022, capmatinib in first-line treatmentMETex14Patients with advanced non-small cell lung cancerORR was 53.3%(Blinded Independent Review Committee assessment) and60% (Investigator Assessment)`, consistent with the data observed globally,`And observed in patients with brain metastasesThe complete response rate (iCR) of intracranial lesions reached 50%.In terms of safety, the overall incidence of adverse reactions in Chinese patients is similar to that of the global population.

In terms of safety, the safety data of capmatinib in this study was generally consistent with that observed in previous studies. The most common adverse reactions were peripheral edema and elevated alanine aminotransferase, mostly grade 1-2 adverse reactions, and overall manageable and controllable. No fatal adverse reactions occurred, no drug interruptions due to adverse reactions, and the incidence of treatment-related serious adverse reactions was 13.3%.