Updated Efficacy and Safety Data and Impact of the EML4-ALK Fusion Variant on the Efficacy of Alectinib in Untreated ALK-Positive Advanced Non–Small Cell Lung Cancer in the Global Phase III ALEX Study

Alectinib continues to demonstrate superior investigator-assessed PFS versus crizotinib in untreated ALK-positive NSCLC, irrespective of EML4-ALK variant. READ HERE

Journal of Thoracic Oncology DOI: 10.1016/j.jtho.2019.03.007

Authors: D. Ross Camidge, Rafal Dziadziuszko, Solange Peters, Tony Mok,Johannes Noe, Malgorzata Nowicka, Shirish M. Gadgeel, Parneet Cheema, MD, Nick Pavlakis, Filippo de Marinis, Byoung Chul Cho, Li Zhang, Denis Moro-Sibilot, Ting Liu, Walter Bordogna, Bogdana Balas, Barbara Müller,Alice T. Shaw

Clinical TrialsKirk SmithMarch 1, 2019ALEX Study, alectinib, ALK variants

Alectinib versus crizotinib in patients with ALK-positive non-small-cell lung cancer (J-ALEX): an open-label, randomised phase 3

These results provide the first head-to-head comparison of alectinib and crizotinib and have the potential to change the standard of care for the first-line treatment of ALK-positive non-small-cell lung cancer. The dose of alectinib (300 mg twice daily) used in this study is lower than the approved dose in countries other than Japan; however, this limitation is being addressed in the ongoing ALEX study. READ ARTICLE

Lancet DOI: 10.1016/S0140-6736(17)30565-2

Authors: Toyoaki Hida MD, Hiroshi Nokihara MD, Masashi Kondo MD, Young Hak Kim MD, Koichi Azuma MD, Takashi Seto MD, Yuichi Takiguchi MD, Makoto Nishio MD, Hiroshige Yoshioka MD, Fumio Imamura MD, Katsuyuki Hotta MD, Satoshi Watanabe MD, Koichi Goto MD, Miyako Satouchi MD, Toshiyuki Kozuki MD, Takehito Shukuya MD, Kazuhiko Nakagawa MD, Tetsuya Mitsudomi MD, Nobuyuki Yamamoto MD,Takashi Asakawa PhD, Ryoichi Asabe MS, Tomohiro Tanaka MS, Tomohide Tamura MD

Clinical TrialsKirk SmithJuly 1, 2017ALEX Study, alectinib, crizotinib

Alectinib (ALC) versus crizotinib (CRZ) in ALK-inhibitor naive ALK-positive non-small cell lung cancer (ALK+ NSCLC): Primary results from the J-ALEX study.

At J-ALEX IA, Alectinib demonstrated significantly prolonged PFS compared with Crizotinib and was well tolerated with a favorable AE profile. READ ARTICLE

Journal of Clinical Oncology DOI: 10.1200/JCO.2016.34.15_suppl.9008

Authors: Hiroshi Nokihara, Toyoaki Hida, Masashi Kondo, Young Hak Kim, Koichi Azuma, Takashi Seto, Yuichi Takiguchi, Makoto Nishio, Hiroshige Yoshioka, Fumio Imamura, Katsuyuki Hotta, Satoshi Watanabe, Koichi Goto, Kazuhiko Nakagawa, Tetsuya Mitsudomi, Nobuyuki Yamamoto, Hiroshi Kuriki, Ryoichi Asabe, Tomohiro Tanaka, Tomohide Tamura