Gadgeel SShaw A.TBarlesi FCrino LCHIH-HSIN YANGDingemans A.-MKim D.-WMarinis FSchulz MLiu SGupta RSmoljanovic VOu S.-H.I.2020-05-262020-05-2620191179-2728https://www.scopus.com/inward/record.uri?eid=2-s2.0-85075088528&doi=10.2147%2fLCTT.S209231&partnerID=40&md5=924fe75f23480729fba0dfea7cfcfdaahttps://scholars.lib.ntu.edu.tw/handle/123456789/494903Introduction: Alectinib is a highly selective and potent ALK inhibitor, approved for the treatment of patients with metastatic ALK+ NSCLC based on results from the Phase II global NP28673 (NCT01801111) and North American NP28761 (NCT01871805) studies. Methods: This exploratory analysis of two Phase II studies of alectinib (NP28673/ NP28761) investigated time to systemic response (TTR) and time to central nervous system (CNS) response (TTCR) in patients with previously treated advanced anaplastic lymphoma kinase fusion gene-positive (ALK+) non-small-cell lung cancer. Patients (n=225) received 600 mg oral alectinib twice daily and had scans every 6/8 weeks (NP28673/NP28761). Results: For NP28673 and NP28761, respectively: median follow-up was 21.3 months/17.0 months; most responders (72.6%/82.9%) responded by the first disease assessment; median TTR was 8 weeks (95% confidence interval [CI]: 8.00–8.14)/6 weeks (95% CI: 5.86–6.14); median TTCR in responders with measurable baseline CNS disease was 8 weeks (95% CI: 7.86–10.29)/6 weeks (95% CI: 5.71–not evaluable). Similar results were observed regardless of measurable/non-measurable disease. Discussion: These data suggest that alectinib achieves a rapid response in patients, both systemically and in the CNS. ? 2019 Gadgeel et al.Alectinib; Non-small-cell lung cancer; NP28673; NP28761; Time to response[SDGs]SDG3alectinib; anaplastic lymphoma kinase; advanced cancer; ALK gene; Article; cancer patient; central nervous system metastasis; clinical assessment; controlled study; drug efficacy; exploratory research; follow up; human; major clinical study; multicenter study (topic); non small cell lung cancer; phase 2 clinical trial (topic); radiodiagnosis; time to central nervous system response; treatment response timejournal article10.2147/LCTT.S2092312-s2.0-85075088528