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Poster display session

3617 - CNS efficacy results from the phase III ALUR study of alectinib vs chemotherapy in previously treated ALK+ NSCLC


09 Sep 2017


Poster display session


Cytotoxic Therapy;  Cancers in Adolescents and Young Adults (AYA);  Targeted Therapy;  Non-Small Cell Lung Cancer


Javier de Castro


Annals of Oncology (2017) 28 (suppl_5): v460-v496. 10.1093/annonc/mdx380


J. de Castro1, S. Novello2, J. Mazieres3, I. Oh4, M.R. Migliorino5, A. Helland6, R. Dziadziuszko7, F. Griesinger8, F. de Marinis9, A. Zeaiter10, A. Cardona10, B. Balas10, H. Johannsdottir10, M. Chlistalla10, V. Smoljanovic10, J. Wolf11

Author affiliations

  • 1 Department Of Medical Oncology, University Hospital, 28046 - La Paz/ES
  • 2 Department Of Oncology, University of Turin, Torino/IT
  • 3 Thoracic Oncology Department, Toulouse University Hospital, Toulouse/FR
  • 4 Department Of Internal Medicine, Chonnam National University Hwasun Hospital, Jeonnam/KR
  • 5 Oncology, A.O. San Camillo Forlanini, Rome/IT
  • 6 Department Of Cancer Genetics And Department Of Oncology, Institute for Cancer Research and University Hospital, Radiumhospitalet, Oslo, Norway and Oslo University Hospital, Radiumhospitalet, Oslo/NO
  • 7 Department Of Oncology And Radiotherapy, Medical University of Gdansk, Gdansk/PL
  • 8 Department Of Hematology And Oncology, Pius Hospital, OIdenburg/DE
  • 9 Division Of Thoracic Oncology, European Institute of Oncology, Milan/IT
  • 10 Oncology, F. Hoffmann-La Roche Ltd., Basel/CH
  • 11 Center For Intergrated Oncology, University Hospital Cologne, Cologne/DE


Abstract 3617


Alectinib has shown central nervous system (CNS) activity in phase II trials of previously treated ALK+ NSCLC. We report CNS efficacy data from the phase III ALUR study (NCT02604342) of alectinib vs standard relapse chemotherapy (CT) in pts with ALK+ NSCLC who previously failed platinum-based doublet CT and crizotinib.


Pts aged ≥18 years with ALK+ NSCLC, previously treated with CT and crizotinib were randomised 2:1 to alectinib (600mg twice daily) or CT (pemetrexed 500mg/m2 every three weeks [q3w] or docetaxel 75mg/m2 q3w) until disease progression (PD), death or withdrawal. After PD, pts could crossover from CT to alectinib. Primary endpoint was progression-free survival (PFS) by investigator assessment in the intent-to-treat (ITT) population. A key secondary endpoint was CNS overall response rate (CORR) by Independent Review Committee (IRC) in pts with measurable CNS mets at baseline (BL) (mC-ITT). Other CNS outcomes were CORR in pts with measurable and non-measurable CNS mets (C-ITT); 6-month cumulative incidence rate in the ITT, and C-ITT; CNS duration of response (CDOR) and disease control rate (CDCR); and safety.


In total, 107 pts were randomised (alectinib n = 72, CT n = 35; ITT) of whom 76 had BL CNS disease (alectinib n = 50, CT n = 26; C-ITT); 40 had measurable CNS mets (alectinib n = 24; CT n = 16; mC-ITT) and 36 had non-measurable CNS mets (alectinib n = 26, CT n = 10; nC-ITT). CNS efficacy endpoints are shown in the Table. The 6-month cumulative incidence rate of CNS PD was 11% (alectinib) vs 48% (CT) in the ITT, 15% vs 52% in the C-ITT and 0% vs 39% in pts without BL CNS disease. Safety and tolerability profile compared favourably for alectinib vs CT.


CNS-related outcomes were significantly improved with alectinib vs chemotherapy in previously treated ALK+ NSCLC. Alectinib reduces CNS PD and prevents the development of new CNS mets.Table:

1346P CNS efficacy endpoints

C-ITT N = 76mC-ITT N = 40
Alectinib N = 50Chemotherapy N = 26Alectinib N = 24Chemotherapy N = 16
CORR, % (95% CI)36054.20
Difference (95% CI) P value36% (13%–57%) p 

Clinical trial identification


Legal entity responsible for the study

F. Hoffmann-La Roche Ltd.


F. Hoffmann-La Roche


J. de Castro: Membership on an advisory board: Astra-Zeneca, Boehringer, MSD, Novartis, Pfizer, Roche. S. Novello: Speaker Bureau: Eli Lilly, BMS, MSD, Astra Zeneca, Roche. J. Mazieres: Honoraria: Novartis, Roche, Pfizer, BMS, MSD. M.R. Migliorino: Honoraria and Advisory board: Bristol Mayer Squibb, Boehringer Ingelheim, MSD, Astra Zeneca. R. Dziadziuszko: Travel accommodation: Roche. Honoraria: Novartis, Tesaro, Clovis. Honoraria and speaker’s bureau: Pfizer, Honoraria and consulting role: Boehringer-Ingelheim, Astra-Zeneca, Ignyta. F. Griesinger: Advisory Board and corporate sponsored research: Roche, Astra Zeneca, Lilly, BMS, MSD, Celgene, Boehringer, Pfizer, Novartis. F. de Marinis: Advisor for BMS, Pfizer, Roche, Astra Zeneca, BI. A. Zeaiter, A. Cardona, B. Balas: Employment with F. Hoffmann-La Roche. H. Johannsdottir: Employee of Hoffmann-La Roche. M. Chlistalla: Employee of F. Hoffmann-La Roche Ltd. V. Smoljanovic: Employee of F. Hoffmann-La Roche Ltd. with stock ownership. J. Wolf: Advisory boards and lecture fees from AstraZeneca, BMS, Boehringer-Ingelheim, Clovis, Lilly MSD, Novartis, Pfizer, Roche. Research support from BMS, MSD, Novartis, Pfizer, Roche. All other authors have declared no conflicts of interest.

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