CCO_Clin_Phase III JALEX Alectinib vs Crizotinib in ALK Inhibitor–Na概要1.ppt

CCO Independent Conference Coverage*of the 2016 ASCO Annual Meeting, June 3 -7, 2016 Phase III J-ALEX: Alectinib vs Crizotinib in ALK Inhibitor–Naive, ALK-Positive NSCLC *CCO is an independent medical education company that provides state-of-the-art medical information to healthcare professionals through conference coverage and other educational programs. This activity is supported by educational grants from Amgen, Ariad,Bayer Healthcare Pharmaceuticals, Celgene Corporation, Genentech, Incyte, Merck, and Taiho Pharmaceuticals. Alectinib in ALK Inhibitor–Naive ALK+ NSCLC (J-ALEX): Background Approximately 4% to 5% of white and Asian pts with advanced NSCLC have ALK gene rearrangements[1] Crizotinib, the first ALK inhibitor to be approved, considered standard frontline treatment of pts with ALK-positive NSCLC Crizotinib has demonstrated PFS of 10.9 mos in ALK inhibitor–naive pts,[2] but pts eventually relapse, mainly because of secondary ALK mutations/amplification or CNS metastases ALK inhibitor, alectinib, demonstrated activity in intracranial tumors and against ALK resistance mutations in preclinical investigation[3-5] AF-001 JP phase I/II study: efficacy in ALK inhibitor–naive ALK+ NSCLC[6, 7] J-ALEX: randomized phase III study of alectinib vs crizotinib in ALK inhibitor–naive pts with ALK-positive NSCLC[8] 1. Chia PL, et al. Clin Epidemiol. 2014;6:423-432. 2. Solomon BJ, et al. N Engl J Med. 2014;371:2167-2177. 3. Sakamoto H, et al. Cancer Cell. 2011;19:679-690. 4. Kodama T, et al. Mol Cancer Ther. 2014;13:2910-2918. 5. Kodama T, et al. Cancer Chemother Pharmacol. 2014;74:1023-1028. 6. Kozuki T, et al. JSMO 2015. Abstract ISS1-2-1. 7. Takeuchi K, et al. Ann Oncol. 2016; 27:185-192. 8. Nokihara H, et al. ASCO 2016. Abstract 9008. Slide credit: Primary endpoint: PFS by independent review facility Secondary endpoint: OS, ORR, PK, QoL, CNS PFS, safety J-ALEX: Study Design Alectinib 300 mg twice daily PO28-day cycle (n = 103) Crizotinib 250 mg twice daily PO