Ensartinib is a second-generation anaplastic lymphoma kinase (ALK) inhibitor developed by Xcovery. In approximately 3–5% of all non-small cell lung cancer (NSCLC) patients, abnormal ALK configuration leads to the production of proteins that promote and maintain the malignant behavior of cancer cells. In particular, inversions in chromosome 2 cause ALK to fuse to echinoderm microtubule-associated protein-like 4. This activates the ALK kinase domain and downstream signaling pathways responsible for excess cancer cell proliferation. Early-phase trials of second-generation ALK inhibitors such as ensartinib have demonstrated their ability to cross the blood-brain barrier and act on tumors in the central nervous system, a common site for distant metastases in ALK-positive NSCLC.
4 Drug Overview
5 Product Profiles
5 ensartinib : Non-small cell lung cancer (NSCLC)
LIST OF FIGURES
8 Figure 73: Datamonitor Healthcare’s drug assessment summary for Xalkori in non-small cell lung cancer
9 Figure 74: Xalkori sales for NSCLC across the US, Japan, and five major EU markets, by country, 2017–26
12 Figure 3: Ensartinib sales for NSCLC across the US, Japan, and five major EU markets, by country, 2017–26
LIST OF TABLES
6 Table 1: Ensartinib drug profile
7 Table 2: Ensartinib Phase III trial in non-small cell lung cancer
7 Table 3: Ensartinib early-phase data in non-small cell lung cancer
13 Table 4: Ensartinib sales for NSCLC across the US, Japan, and five major EU markets, by country ($m), 2017–26
15 Table 5: Ensartinib patient numbers for NSCLC across the US, Japan, and five major EU markets, by country, 2017–26
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