Captatinib, a specific subtype of Novartis lung cancer treatment drug, has been given priority by FDA

Compiling coco On February 11, Novartis announced that the U.S FDA accepted the new drug application (NDA) of capmatinib (inc280), and granted priority review Capmatinib is an oral and selective met inhibitor Incyte authorized the research of the compound to Novartis in 2009 According to the agreement, Novartis obtained the global exclusive right to develop and commercialize all indications of capmatinib Carmatinib is currently being evaluated in patients with locally advanced or non-small cell lung cancer (NSCLC) with metastatic met exon 14 leap (metex14) mutations for first-line and prior treatment If approved, carmatinib would be the first treatment for advanced lung cancer with a mutation in metex14 The priority review will shorten the FDA review period of the drug after receiving NDA to six months and the standard review to 10 months Kamatinib has previously been awarded the title of breakthrough therapy "We are very encouraged that capmatinib has won the FDA's priority review, which is a significant progress in the treatment of this particularly aggressive lung cancer," said John Tsai, global director of drug development and chief medical officer, Novartis The results of the mono-1 trial confirm that metex14 is the driving factor of cancer, and we expect to provide the first metex14 targeted therapy "carmatinib" for lung cancer patients and bring positive prognosis " The NDA submission was supported by the results of the geometry mono-1 phase II clinical study, which showed that the overall remission rates of carbamazepine were 67.9% (95% CI, 47.6-84.1) and 40.6% (95% CI, 28.9-53.1) in untreated patients and in patients who had previously received treatment (failure of one or two rounds of chemotherapy) The study also demonstrated that camatinib provides a sustained response in all patients: the median response duration was 11.14 months (95% CI, 5.55-ne) in the first treatment and 9.72 months (95% CI, 5.55-12.98) in the previous treatment All results were evaluated by the blind independent review committee of RECIST v1.1, and all CT scans of tumors were evaluated by two radiologists in parallel to confirm the efficacy In all cohorts (n = 334), the most common treatment-related adverse events (all grades ≥ 10%) were peripheral edema (42%), nausea (33%), creatinine elevation (20%), vomiting (19%), fatigue (14%), loss of appetite (13%) and diarrhea (11%) Lung cancer is the most common cancer in the world, with 2.1 million new cases and 1.8 million deaths in 2018 There are two main types of lung cancer: small cell lung cancer and non-small cell lung cancer NSCLC accounts for about 85% of lung cancer diagnosis, including known carcinogenic mutations Mutations in exon 14 of met occurred in 3% - 4% of newly diagnosed advanced NSCLC cases At present, there is no approved targeted therapy for advanced lung cancer with metex14 mutation Metex14 mutations are recognized as cancer drivers Novartis, in collaboration with foundation medicine, is developing an accompanying diagnostic agent for carbamazepine for tumor tissue and liquid biopsy, which will be included in foundationone CDX and the upcoming foundation medicine liquid biopsy platform, and is currently under FDA review At the annual meeting of the American Society of clinical oncology in 2019, Novartis and Merck launched their drug data for specific types of lung cancer The study of Merck tepotinib showed that its total remission rate was about 45% - 50% in all patients, and the difference was that the tumor change was determined by liquid biopsy or tissue biopsy Previously, both drugs have been designated by FDA fast track But now, Novartis seems to be one step ahead If approved on time, carmatinib may beat tepatinib to become the first drug specifically designed to treat this subtype of NSCLC At the same time, the future goal of these two drugs is to expand to EGFR mutation and CMET amplification NSCLC patients who are used in the progress of EGFR inhibitor treatment Novartis is experimenting with a combination of carmatini and Iressa from AstraZeneca for such patients Merck combined the third generation EGFR-TKI drug tagrisso with tepotinib in insight 2 study However, in the field Merck is trying to explore, and Huang pharmaceutical savortinib seems to be the fastest player In cooperation with AstraZeneca, it has published some early results of the button test in 2019: in the patients with NSCLC with met driven EGFR gene mutation resistant to tagrisso, the combined response rate of savortinib + tagrisso is 28%, and the median response lasts for 9.7 months The response rate of this combination was 52% in NSCLC patients who relapsed after the first or second generation TKI treatment.