bristol township school district Appendix A-21

In 20, entrectinib received United States and European Union approval/marketing authorizations for the treatment of patients ≥12 years old with NTRK fusion-positive solid tumors and adults with ROS1 fusion-positive non–small cell lung cancer (NSCLC).

Entrectinib is a potent inhibitor of TRK, ROS1, and ALK and was specifically designed to penetrate and remain in the central nervous system (CNS refs. NTRK fusion-positive solid tumors can be treated using targeted therapies, such as larotrectinib and entrectinib, the first two TRK inhibitors approved in the United States ( 5). These results confirm data that supported the United States (2019) and European (2020) approvals and inform physicians of the latest advances in the field of tumor-agnostic therapies, improving patient access to treatments tailored for their condition. In line with previous reports, entrectinib had a manageable safety profile, with most treatment-related adverse events grade 1/2 and reversible.

At clinical cut-off (August 31, 2020), the overall and intracranial efficacy of entrectinib were confirmed with response rate 61.2%, median duration of response 20.0 months, median progression-free survival 13.8 months, and intracranial response rate 63.6% (in 11 patients with measurable central nervous system disease by blinded independent review). We report updated results from this analysis with a longer follow-up and a larger patient cohort ( n = 121). In previous reports of an integrated analysis of three phase I/II trials, entrectinib yielded deep and durable overall and intracranial responses in 54 patients with NTRK fusion-positive solid tumors, including rare tumor types.

Bristol township school district Appendix A-21