June 12, 2024, Shanghai, China — Novartis China announced that its non-small cell lung cancer drug Tyrosine Kinase Inhibitor (Toremifene)®(Novartis' Capmatinib Hydrochloride Tablets) have been approved by the National Medical Products Administration of China for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations who have not received prior systemic treatment.® The approval brings 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.
Ian Li, President and Managing Director of Novartis China, said:"Very glad to see Toreada"®Approved in China, becoming a new treatment option for Chinese patients with METex14 skipping non-small cell lung cancer. Novartis has been deeply involved in the field of lung cancer for many years, offering multiple targeted therapy products for driver gene-positive non-small cell lung cancer, including innovative treatments targeting rare mutations like METex14. Moving forward, we will accelerate the development of Toreada.®The marketing process will be pushed forward to improve the drug accessibility and bring benefits to more patients as soon as possible. Meanwhile, we will continue to be patient-centered, constantly explore, and develop innovative therapies to bring new hope to cancer patients and help advance the development of China's oncology treatment field."
In China, the incidence and mortality rates of lung cancer rank first among all types of cancers. In 2022, there were 1.0606 million new cases of lung cancer, accounting for 22.0% of all malignant tumors, and the mortality rate accounted for 28.5% of all malignant tumor deaths.[1]In lung cancer, non-small cell lung cancer (NSCLC) accounts for as high as 80%-85% of patients.[2], and there are multiple driver gene mutations. Among them, METex14 skipping mutation is one of the key driver genes, which has been confirmed as an independent oncogenic factor in non-small cell lung cancer.[3]METex14 skipping mutation leads to the loss of the c-Cbl tyrosine binding site, resulting in reduced proteasome-mediated MET protein degradation and sustained activation of downstream signaling pathways.[4], thereby promoting the migration, proliferation, and invasion of tumor cells. In NSCLC patients, the METex14 skipping mutation rate is approximately 1%-3%.[5][6][7], often occurring in older individuals (median age of 72.5 years), with limited effectiveness from traditional treatments such as chemotherapy and immunotherapy.
Since the disease is caused by abnormal activation of the MET signaling pathway, MET inhibitors have become an important treatment for METex14 skipping mutations. Toremifene®(Capmatinib Hydrochloride Tablets) is an orally bioavailable, highly selective, and specific MET receptor tyrosine kinase inhibitor that effectively inhibits 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.
Professor Wu Yilong from Guangdong Provincial People's Hospital stated:"Although METex14 is a rare target in lung cancer, the population it affects in China is still significant, and the need for treatments targeting this mutation is extremely 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."
Support Toreada®(Capmatinib Hydrochloride Tablets) The clinical research data approved in China are from the global multicenter clinical study GeoMETry mono-1 and the registration clinical study GeoMETry-C for the Chinese population. The GeoMETry mono-1 study showed that, according to the assessment by the blinded independent review committee, the objective response rate (ORR) and disease control rate (DCR) of capmatinib in treating previously untreated patients with advanced non-small cell lung cancer with METex14 skipping mutations were 68.3% and 98.3%, respectively, and the median overall survival (OS) was 25.5 months.[8]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 METex14 skipping mutation advanced non-small cell lung cancer patients was 53.3% (assessed by a 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.[9]。
Notably, to ensure that Chinese patients can access innovative therapies as soon as possible, Toreada...®Before being officially approved in China, it 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 at the beginning of 2022. It has also been applied in specific medical institutions in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan for urgent clinical needs.
In order to better meet the needs of patients in China, as a globally leading innovative pharmaceutical company, Novartis fully utilizes its own advantages, actively responds to national innovation policies, and accelerates the introduction of new drugs. In the future, Novartis will rely on China's pharmaceutical policies to speed up the entry of innovative drugs into the Chinese market, providing more high-quality drug options. At the same time, Novartis will continue to promote the development of the pharmaceutical industry and contribute to the improvement of global health.
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 presence in the Chinese market, from research and development, production to business development. We are committed to providing innovative drugs with high clinical value for Chinese patients. 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 enhance 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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