Time To Response In Patients With Advanced Anaplastic Lymphoma Kinase ( ALK )-Positive Non-Small-Cell Lung Cancer (NSCLC) Receiving Alectinib In The Phase II NP28673 And NP28761 Studies.

Autor:	Gadgeel S; Department of Internal Medicine, Division of Hematology and Oncology, The University of Michigan, Ann Arbor, MI 48109, USA., Shaw AT; Center for Thoracic Cancers, Massachusetts General Hospital, Boston, MA, USA., Barlesi F; Multidisciplinary Oncology and Therapeutic Innovations Department, Aix-Marseille University, Assistance Publique Hôpitaux de Marseille, Marseille 13005, France., Crino L; Department 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., Yang JC; National Taiwan University Hospital and National Taiwan University Cancer Centre, Taipei City, Taiwan., Dingemans AM; Department of Pulmonology, Maastricht University Medical Centre, Maastricht 6229 HX, The Netherlands., Kim DW; Department of Internal Medicine, Seoul National University Hospital, Jongno-Gu, Seoul 03080, South Korea., de Marinis F; Division of Thoracic Oncology, European Institute of Oncology IRCCS, Milan 20146, Italy., Schulz M; Division of Thoracic Oncology, European Institute of Oncology IRCCS, Milan 20146, Italy., Liu S; Genentech Inc., South San Francisco, CA, USA., Gupta R; Genentech Inc., South San Francisco, CA, USA., Smoljanovic V; F. Hoffmann-La Roche Ltd., Basel CH-4070, Switzerland., Ou SI; Division of Hematology-Medical Oncology, Department of Internal Medicine, University of California, Irvine School of Medicine, Orange, CA 92617, USA.
Jazyk:	angličtina
Zdroj:	Lung Cancer (Auckland, N.Z.) [Lung Cancer (Auckl)] 2019 Nov 13; Vol. 10, pp. 125-130. Date of Electronic Publication: 2019 Nov 13 (Print Publication: 2019).
DOI:	10.2147/LCTT.S209231
Abstrakt:	Introduction: 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. Competing Interests: 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. (© 2019 Gadgeel et al.)
Databáze:	MEDLINE
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