Novartis Announces NMPA Approval of Capmatinib in China for First-Line Treatment of METex14 Skipping Mutation-Positive Advanced NSCLC

Jun 13, 2024 07:46 CST Updated 07:46

Novartis

Drug Development and Manufacturing

June 12,NovartisAnnounced that the company's hydrochloric acidCapmatinibToremifene Tablets (Toreada®) have been approved for marketing by the China National Medical Products Administration for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying mesenchymal-epithelial transition factor (MET) exon 14 skipping mutations who have not received systemic treatment.

Capmatinib Hydrochloride Tablets are an orally bioavailable, highly selective, and specific MET receptor tyrosine kinase (c-Met) inhibitor that effectively inhibits the phosphorylation of MET and MET-mediated downstream signaling proteins, thereby suppressing tumor cell proliferation and migration while effectively inducing apoptosis, demonstrating anti-tumor activity.

The clinical research data supporting the approval of capmatinib hydrochloride tablets in China include the global multicenter clinical study GeoMETry mono-1 and the registration clinical study for the Chinese population, GeoMETry-C. The GeoMETry mono-1 study showed that, according to assessments by the blinded independent review committee, the objective response rate (ORR) and disease control rate (DCR) of capmatinib in first-line treatment of advanced non-small cell lung cancer patients with METex14 skipping 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, the ORR of capmatinib in first-line treatment of patients with METex14 skipping mutation advanced non-small cell lung cancer was 53.3% (assessed by the blinded independent review committee) and 60% (investigator-assessed), consistent with the data observed globally. A complete intracranial response rate (iCR) of 50% was observed in patients with brain metastases. In terms of safety, the overall incidence of adverse reactions in Chinese patients was similar to that in the global population.

From May 2020 to present, Capmatinib has been successively approved in the United States, Japan, the European Union, and Switzerland., Brazil, Singapore, and other countries and regions, and is prioritized in international guidelines for the treatment of METex14 exon-skipping non-small cell lung cancer.

Notably, to ensure that Chinese patients can access innovative therapies as soon as possible, Toreada® was included in the second list of urgently needed imported drugs and medical devices from Hong Kong and Macao for clinical use in the mainland of the Guangdong-Hong Kong-Macao Greater Bay Area in early 2022, before its official approval in China. Additionally, it has been applied in specific medical institutions within the Boao Lecheng International Medical Tourism Pilot Zone in Hainan for urgent clinical needs.

Professor Wu Yilong stated: "Although METex14 is a rare target in lung cancer, the population it affects in China is also significant, and the need for treatment targeting this mutation is very urgent. The approval of Capmatinib Hydrochloride Tablets in China has opened a new chapter in the treatment of NSCLC in China, bringing new hope to a large number of patients."

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