Data Sharing

Qualified researchers may request access to individual patient-level data through the clinical study data request platform ( Further details on Roche’s criteria for eligible studies are available here ( For further details on Roche’s Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here.


Continue Reading

The authors would like to acknowledge Dr Leena Gandhi for her contributions to this analysis. The authors thank the patients, their families, and the participating study centers. Third-party medical writing assistance, under the direction of the authors, was provided by Emma Evans, PhD, of Gardiner-Caldwell Communications, and was funded by F. Hoffmann-La Roche Ltd. This work was supported by F. Hoffmann-La Roche Ltd.

Author Contributions

All authors contributed to data analysis, drafting and revising the article, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.


SG has received consultancy fees from Araid, Genentech/Roche, and AstraZeneca and personal fees from Genentech/Roche, Takeda, AstraZeneca, Xcovery, and Boehringer-Ingelheim, during the conduct of the study. ATS has received fees for consulting and advisory boards from Pfizer, Novartis, Chugai, Genentech/Roche, Ariad, Daiichi-Sankyo, and Blueprint Medicines; consultancy fees from Ignyta, Taiho, and Foundation Medicine; and advisory board fees from Loxo, EMD Serono, and Natera. FB has received consulting fees and honorarium from F. Hoffmann-La Roche Ltd.; and consultancy fees from AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Clovis Oncology, Eli Lilly Oncology, Novartis, Merck, MSD, Pierre Fabre, Takeda, and Pfizer. JCHY has received fees for advisory board/speech from Boehringer Ingelheim, AstraZeneca, Roche/Genentech, Chugai, BMS, Ono Pharmaceuticals, and Pfizer; and advisory board fees from Bayer, Eli Lilly, MSD, Merck Serono, Novartis, Celgene, Merrimack, Yuhan Pharmaceuticals, Hansoh Pharmaceuticals, Takeda Pharmaceuticals, Blueprint Medicines, G1 Therapeutics, and Daiichi Sankyo. AMD has received consulting fees and honorarium from Roche; and consulting fees from BMS, Eli Lilly, AstraZeneca, Clovis, MSD, Takeda, and Boehringer Ingelheim. DWK has received non-financial support from F. Hoffmann-La Roche Ltd. for travel to meetings for the study or other purposes, and provision of writing assistance, medicines, equipment, or administrative support; and non-financial support from Novartis Oncology for travel to advisory meetings. FDM has received personal fees from AstraZeneca, MSD, Bristol-Myers Squibb, and Roche. MS is an employee of Genentech and holds Roche shares and Settled Stock Appreciation Rights. SL was an employee of Genentech during the study conduct. RG is an employee of Genentech. VS is an employee of F. Hoffmann-La Roche Ltd. SHIO has received personal fees from Pfizer, Roche, AstraZeneca, Merck, and Takeda/ARIAD, Foundation Medicine Inc., owns stock from and a member of the Scientific Advisory Board of Turning Point Therapeutics Inc., outside the submitted work. The authors report no other conflicts of interest in this work.

Shirish Gadgeel,1 Alice T Shaw,2 Fabrice Barlesi,3 Lucio Crino,4 James CH Yang,5 Anne-Marie Dingemans,6 Dong-Wan Kim,7 Filippo de Marinis,8 Mathias Schulz,8 Shiyao Liu,9 Ravindra Gupta,9 Vlatka Smoljanovic,10 Sai-Hong Ignatius Ou11

1Department of Internal Medicine, Division of Hematology and Oncology, The University of Michigan, Ann Arbor, MI 48109, USA; 2Center for Thoracic Cancers, Massachusetts General Hospital, Boston, MA, USA; 3Multidisciplinary Oncology and Therapeutic Innovations Department, Aix-Marseille University, Assistance Publique Hôpitaux de Marseille, Marseille 13005, France; 4Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Srl I.R.C.C.S., Meldola, FC 47014, Italy; 5National Taiwan University Hospital and National Taiwan University Cancer Centre, Taipei City, Taiwan; 6Department of Pulmonology, Maastricht University Medical Centre, Maastricht 6229 HX, The Netherlands; 7Department of Internal Medicine, Seoul National University Hospital, Jongno-Gu, Seoul 03080, South Korea; 8Division of Thoracic Oncology, European Institute of Oncology IRCCS, Milan 20146, Italy; 9Genentech Inc., South San Francisco, CA, USA; 10F. Hoffmann-La Roche Ltd., Basel CH-4070, Switzerland; 11Division of Hematology-Medical Oncology, Department of Internal Medicine, University of California, Irvine School of Medicine, Orange, CA 92617, USA

Correspondence: Sai-Hong Ignatius Ou
University of California, Irvine School of Medicine, 1001 Health Sciences Road, Irvine, Orange, CA 92617, USA
Tel +1 714 456 8104
Email [email protected]


1. Gainor JF, Dardaei L, Yoda S, et al. Molecular mechanisms of resistance to first- and second-generation ALK inhibitors in ALK-rearranged lung cancer. Cancer Discov. 2016;6:1118–1133. doi:10.1158/2159-8290.CD-16-0596

2. Costa DB, Kobayashi S, Pandya SS, et al. CSF concentration of the anaplastic lymphoma kinase inhibitor crizotinib. J Clin Oncol. 2011;29:e443–e445. doi:10.1200/JCO.2010.34.1313

3. Yang JC, Ou SI, De Petris L, et al. Pooled systemic efficacy and safety data from the pivotal phase II studies (NP28673 and NP28761) of alectinib in ALK-positive non-small cell lung cancer. J Thorac Oncol. 2017;12:1552–1560. doi:10.1016/j.jtho.2017.06.070

4. Gadgeel SM, Shaw AT, Govindan R, et al. Pooled analysis of CNS response to alectinib in two studies of pretreated patients with ALK-positive non-small-cell lung cancer. J Clin Oncol. 2016;34:4079–4085. doi:10.1200/JCO.2016.68.4639

5. Ou SH, Gandhi L, Shaw AT, et al. Updated pooled analysis of CNS endpoints in two phase II studies of alectinib in ALK+ NSCLC. J Thorac Oncol. 2017;12(Suppl.1):MA07.01. doi:10.1016/j.jtho.2016.09.002

6. Ou SH, Ahn JS, De Petris L, et al. Alectinib in crizotinib-refractory ALK-rearranged non-small-cell lung cancer: a phase II global study. J Clin Oncol. 2016;34:661–668. doi:10.1200/JCO.2015.63.9443

7. Camidge DR, Gadgeel S, Ou SH, et al. Updated efficacy and safety data from the phase 2 NP28761 study of alectinib in ALK-positive non-small-cell lung cancer. J Thorac Oncol. 2017;12(Suppl.1):MA07.02. doi:10.1016/j.jtho.2016.11.426

8. Kodama T, Hasegawa M, Takanashi K, et al. Antitumor activity of the selective ALK inhibitor alectinib in models of intracranial metastases. Cancer Chemother Pharmacol. 2014;74:1023–1028. doi:10.1007/s00280-014-2578-6

9. Camidge DR, Dziadziuszko R, Peters S, et al. 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. J Thorac Oncol. 2019;14(7):1233–1243. [Epub ahead of print].

10. Zhou C, Kim SW, Reungwetwattana T, et al. Alectinib versus crizotinib in untreated Asian patients with anaplastic lymphoma kinase-positive non-small-cell lung cancer (ALESIA): a randomised phase 3 study. Lancet Respir Med. 2019;7:437–446. doi:10.1016/S2213-2600(19)30053-0

11. Seto T, Nishio M, Hida T, et al. Final PFS analysis and safety data from the phase III J-ALEX study of alectinib (ALC) vs. crizotinib (CRZ) in ALK-inhibitor naïve ALK-positive non-small cell lung cancer (ALK+ NSCLC). J Clin Oncol. 2019;37(15_suppl):9092–9092S.

12. Gadgeel S, Peter S, Mok T, et al. Alectinib vs crizotinib in treatment-naïve ALK+ NSCLC: CNS efficacy results from the ALEX study. Ann Oncol. 2017;28(suppl_5):v605–v649. doi:10.1093/annonc/mdx440.057

13. Takiguchi Y, Hida T, Nokihara H, et al. Updated efficacy and safety of the J-ALEX study comparing alectinib (ALC) with crizotinib (CRZ) in ALK-inhibitor naïve ALK fusion positive non-small cell lung cancer (ALK+ NSCLC). J Clin Oncol. 2017;35(Suppl.15):Abs9064. doi:10.1200/JCO.2017.35.15_suppl.9064

Source: Lung Cancer: Targets and Therapy.
Originally published November 13, 2019.

READ FULL ARTICLE Curated publisher From Dovepress