1299O_PR - Primary results from the phase III ALUR study of alectinib versus chemotherapy in previously treated ALK+ non-small-cell lung cancer (NSCLC)

Date 11 September 2017
Event ESMO 2017 Congress
Session NSCLC, metastatic 2
Topics Anti-Cancer Agents & Biologic Therapy
Non-Small-Cell Lung Cancer, Metastatic
Lung and other Thoracic Tumours
Presenter Silvia Novello
Citation Annals of Oncology (2017) 28 (suppl_5): v605-v649. 10.1093/annonc/mdx440
Authors S. Novello1, J. Mazieres2, I. Oh3, J. de Castro4, M.R. Migliorino5, A. Helland6, R. Dziadziuszko7, F. Griesinger8, A. Kotb9, A. Zeiter9, A. Cardona9, B. Balas9, H. Johannsdottir9, A. Das-Gupta9, J. Wolf10
  • 1Department Of Oncology, University of Turin, 10124 - Torino/IT
  • 2Thoracic Oncology Department, Toulouse University Hospital, Toulouse/FR
  • 3Department Of Internal Medicine, Chonnam National University Medical School & Chonnam National University Hwasun Hospital, 519-809 - Hwasun/KR
  • 4Department Of Medical Oncology, University Hospital, Madrid/ES
  • 5Oncology, A.O. San Camillo Forlanini, Rome/IT
  • 6Department Of Cancer Genetics And Department Of Oncology, Institute for Cancer Research, Oslo University Hospital, Oslo/NO
  • 7Department Of Oncology And Radiotherapy, Medical University of Gdansk, Gdansk/PL
  • 8Department Of Hematology And Oncology, Pius Hospital, OIdenburg/DE
  • 9Oncology, F. Hoffmann-La Roche Ltd., Basel/CH
  • 10Center For Intergrated Oncology, University Hospital Cologne, 50937 - Cologne/DE

Abstract

Background

ALK+ NSCLC current standard of care is crizotinib. However, many pts experience progressive disease (PD) within a year, often in the central nervous system (CNS). Alectinib (ALC) has shown systemic and CNS efficacy in phase II trials of previously treated ALK+ NSCLC after crizotinib failure. The phase III ALUR study (NCT02604342) investigated efficacy and safety of ALC vs standard relapse chemotherapy (CT) in ALK+ NSCLC previously treated with platinum-based doublet CT and crizotinib.

Methods

Pts aged ≥18 years with previously treated ALK+ NSCLC were randomised 2:1 to ALC (600mg twice daily) or CT (pemetrexed 500mg/m2 q3w or docetaxel 75mg/m2 q3w) until PD, death or withdrawal. Crossover from CT to ALC was permitted after PD. Primary outcome was progression-free survival (PFS) by investigator (INV) assessment. Secondary outcomes included PFS by Independent Review Committee (IRC), overall response rate (ORR) and CNS ORR (CORR) by IRC, disease control rate (DCR), duration of response (DOR) and safety.

Results

107 pts were randomised (ALC n = 72; CT n = 35); 104 received ≥1 dose of study drug (ALC n = 70; CT n = 34). At data cut-off (26.01.17) median follow-up: 6.5 months ALC, 5.8 months CT. Median treatment duration: 20.1 weeks ALC, 6.0 weeks CT. Median PFS by INV was 9.6 months (95% CI 6.9–12.2) ALC, 1.4 months (95% CI 1.3–1.6) CT (HR 0.15, 95% CI 0.08–0.29; p 

Conclusions

ALC significantly improved systemic and CNS efficacy, including PFS and ORR, vs CT for previously treated ALK+ NSCLC, with a favourable safety profile vs CT.

Clinical trial identification

Legal entity responsible for the study

F. Hoffmann - La Roche Ltd.

Funding

F. Hoffmann - La Roche Ltd.

Disclosure

S. Novello: Speaker Bureau: Eli Lilly, BMS, MSD, Astra Zeneca, Roche. J. Mazieres: Honoraria from Novartis, Roche, Pfizer, BMS, MSD. J. de Castro: Membership on an advisory board: Astra-Zeneca, Boehringer, MSD, Novartis, Pfizer, Roche. 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 speakers 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. A. Kotb, A. Cardona, B. Balas, H. Johannsdottir, A. Das-Gupta: Employee of F. Hoffmann-La Roche Ltd. A. Zeiter: Employee of F. Hoffmann-La Roche Ltd. with stock ownership. J. Wolf: Advisory boards and lecture fees: AstraZeneca, BMS, Boehringer-Ingelheim, Clovis, Lilly, MSD, Novartis, Pfizer, Roche. Research support: BMS, MSD, Novartis, Pfizer, Roche. All other authors have declared no conflicts of interest.