Weigh! First line drugs approved by alectinib will become the new king of ALK + lung cancer Market

Source: Medical magic cube data on November 7, 2017-11-08, Roche announced that FDA approved alecensa (alectinib) supplementary application for the first-line treatment of non-small cell lung cancer patients with positive mutation of anaplastic lymphoma kinase (ALK) At the same time, FDA changed the listing qualification of alectinib second-line treatment ALK + NSCLC from accelerated approval to full approval FDA's approval was based on data from a phase III study, codenamed Alex In the Alex study, alectinib reduced the risk of disease progression and death by 47% and significantly prolonged PFS (25.7 vs 10.4 months) in patients with ALK + NSCLC compared with the first-line standard drug, clozatinib What's more, compared with czotinib, alectinib can also reduce the risk of brain metastasis or continued growth in the brain / central nervous system by 84% CNS orr was 38% (n = 21) and 5% (n = 22) in patients with brain metastasis, respectively In non-small cell lung cancer (NSCLC) patients, the positive rate of ALK + is about 3% ~ 5% About 10000 new cases of ALK + NSCLC are newly confirmed in the United States every year Although the number is far lower than that of EGFR mutation positive patients, most of the ALK + patients are young patients, most of them have no response to chemotherapy drugs, limited treatment options and poor prognosis Pfizer xalkori (czotinib) is the first lung cancer targeting drug for ALK mutation in the world After treatment, Orr can reach 60% and PFS can reach 8-10 months On August 26, 2011, PFS was approved by FDA to treat ALK positive advanced NSCLC Pfizer xalkori is one of the fastest developing drugs in the history of cancer drugs, and it quickly became the standard drug for ALK + NSCLC patients However, most of the patients with ALK + will develop drug resistance after using clozatinib for one year, and the patients with brain metastasis are also very common, and clozatinib can not work through the blood-brain barrier It has become a research hotspot to find out the mechanism of drug resistance of ALK inhibitors and to explore new ALK targeted therapeutic drugs After clozatinib, FDA approved three kinds of ALK inhibitors, which provided a new drug choice for drug resistant patients with ALK + NSCLC Now, after the FDA approved ALK inhibitor, Novartis zykadia (seretinib) and Roche alecensa (alectinib) have been promoted to the first-line medication for ALK + NSCLC patients, which means that patients have more choice of medication But in terms of clinical data, alectinib is better Zykadia was approved as the first-line drug for ALK + NSCLC patients by FDA on May 26 this year with the data of the ascend-4 study Data showed that compared with standard first-line chemotherapy (pemetrexed, platinum, n = 187), zykadia significantly prolonged PFS (16.6 vs 8.1 months) The median PFS of zykadia and chemotherapy group were 26.3 and 8.3 months for patients without brain metastasis, and 10.7 and 6.7 months for patients with brain metastasis For patients with ALK + NSCLC who can detect brain metastasis, the overall intracranial response rate of zykadia treatment group was 57% (n = 28), and that of chemotherapy group was 22% (n = 27) (see: new indications of Novartis zykadia approved: first-line treatment of ALK positive NSCLC) According to the prediction of evaluatepharma, alecensa's market share can anti surpass zykadia in 2018 and xalkori around 2022, becoming the most popular drug in ALK + NSCLC ALK inhibitor sales forecast ($million) source: evaluatepharma