Starting September 14, Novartis' innovative oral medication Taurida for the treatment of non-small cell lung cancer (NSCLC) with MET exon 14 skipping mutations (METex14)®(Capmatinib Hydrochloride Tablets) have been supplied to pharmacies in multiple provinces and cities, including Beijing, Tianjin, Hebei, Jiangsu, Shandong, Shanghai, Guangdong, Zhejiang, Shaanxi, and Fujian. Currently, the first prescriptions have been issued at the Cancer Hospital of the Chinese Academy of Medical Sciences, Guangdong Provincial People's Hospital, the First Affiliated Hospital of Zhejiang University School of Medicine, and Nantong Tumor Hospital.
Capmatinib Hydrochloride Tablets were approved in China in June 2024 for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition factor (MET) exon 14 skipping mutations who have not received systemic treatment. It is also the world's first MET inhibitor approved by the U.S. Food and Drug Administration (FDA).From approval to supply and clinical application, the Cammetinib Hydrochloride Tablets provide a new solution to address the challenges of METex14 skipping NSCLC treatment, offering patients a new option and hope.
In China, lung cancer is the cancer with the highest incidence and mortality rate.1, of which, non-small cell lung cancer (NSCLC) patients account for as high as 80%-85%.2，With the development of precision diagnosis and treatment, an increasing number of lung cancer patients have achieved longer survival benefits. However, compared with common targets, rare/uncommon targets should not be ignored. Among them, METex14 skipping mutation, as one of the driver genes of advanced NSCLC, has a mutation rate of approximately 0.9%–2.0% in the non-small cell lung cancer population in mainland China.3, the prognosis of the disease is poor. Conventional treatments such as chemotherapy, immunotherapy, and some targeted drugs have limited efficacy for NSCLC patients carrying this mutation. Real-world studies show that the objective response rate (ORR) of chemotherapy is only 27.8% in first-line treatment and 30.0% in second-line treatment.4; Immunotherapy also has limited efficacy in this patient population, with an ORR of only 17% and a median progression-free survival (mPFS) of 1.9 months.5Therefore, there is a significant unmet clinical need for such patients.
Since the disease is caused by abnormal activation of the MET signaling pathway, the advent of specific MET inhibitors targeting the mutation mechanism has become an important treatment for METex14 skipping mutation NSCLC.
Capmatinib Hydrochloride Tablets are an orally highly bioavailable, highly selective, and specific MET receptor tyrosine kinase inhibitor. It can inhibit the phosphorylation of MET and MET-mediated downstream signaling proteins, thereby suppressing tumor cell proliferation and migration, and effectively inducing apoptosis, demonstrating anti-tumor activity. This provides a new treatment option for patients with non-small cell lung cancer in China.
Global multicenter and multiple clinical studies in China have confirmed that capmatinib hydrochloride tablets have demonstrated significant anti-tumor activity in patients with advanced NSCLC carrying MET exon 14 skipping mutations. Data from the GEOMETRY mono-1 study showed that in 60 treatment-naïve patients, the objective response rate (ORR) assessed by the Blinded Independent Review Committee (BIRC) reached 68.3%, with a median overall survival (mOS) of 25.5 months.6。
Moreover, among patients with advanced METex14 skipping NSCLC, approximately 37% have brain metastases, adversely affecting their quality of life and prognosis.7Cametinib, as a small molecule MET inhibitor, has been found in studies to be able to cross the blood-brain barrier and inhibit intracranial metastatic lesions.8In the GEOMETRY mono-1 study, which enrolled 13 patients with brain metastases who had measurable intracranial lesions at baseline, 7 patients experienced intracranial responses, and 4 patients achieved complete resolution of brain lesions. The intracranial complete response rate (iCR) assessed by BIRC was 31%, and the intracranial objective response rate (iORR) was 54%.6. While in the Chinese registration clinical study GEOMETRY-C9, it was also observed that 2 out of 4 patients with baseline brain metastases achieved complete intracranial response, with an iCR rate of 50%.9。
The first batch of prescriptions for Capmatinib Hydrochloride Tablets has been issued in China,To provide new solutions for addressing the treatment challenges of METex14 skipping NSCLC and offer new treatment options for non-small cell lung cancer patients in China., helping doctors and patients better address disease challenges and improve patients' quality of life.
About Novartis
Novartis is a global leading innovative pharmaceutical company. Our mission is to reimagine medicine to improve people's quality of life and extend human lifespan. In 2023, approximately 284 million patients worldwide benefited from Novartis products. Adhering to the concept of "Commitment to China," Novartis has comprehensively laid out its strategy in the Chinese market, spanning research and development, production, and business development. We are committed to providing innovative drugs with high clinical value to patients in China. Since 1987, Novartis has received approval in China for over 100 innovative drugs and new indications. By deepening multi-faceted cooperation with all parties in China’s healthcare ecosystem, Novartis continuously helps improve disease diagnosis and treatment standards, actively fulfills corporate responsibilities, promotes the implementation of the Healthy China strategy, and thereby makes tangible and positive contributions to China's development.
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2. The information contained in this material is for reference only. Please follow the advice or guidance of doctors or other healthcare professionals.