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Poster Discussion – NSCLC, metastatic

3850 - Final PFS, updated OS and safety data from the randomised, phase III ALEX study of alectinib (ALC) versus crizotinib (CRZ) in untreated advanced ALK+ NSCLC


29 Sep 2019


Poster Discussion – NSCLC, metastatic


Tony S.K. Mok


Annals of Oncology (2019) 30 (suppl_5): v602-v660. 10.1093/annonc/mdz260


T.S.K. Mok1, A.T. Shaw2, R.D. Camidge3, S.M. Gadgeel4, R. Rosell5, R. Dziadziuszko6, D. Kim7, M. Perol8, S. Ou9, W. Bordogna10, V. Smoljanović10, M. Hilton10, S. Peters11

Author affiliations

  • 1 State Key Laboratory Of Translational Oncology, The Chinese University of Hong Kong, Shatin - Hong Kong/HK
  • 2 Hematology/oncology; Medicine, Massachusetts General Hospital, Boston/US
  • 3 Medical Oncology, University of Colorado, 80045 - Aurora/US
  • 4 Department Of Internal Medicine, Rogel Cancer Center, University of Michigan, Ann Arbor/US
  • 5 Medical Oncology, Catalan Institute of Oncology, 08907 - Barcelona/ES
  • 6 Department Of Oncology And Radiotherapy, Medical University of Gdansk, Gdansk/PL
  • 7 Medical Oncology, Seoul National University Hospital, Seoul/KR
  • 8 Department Of Medical Oncology, Centre Léon Bérard, 69008 - Lyon/FR
  • 9 Chao Family Comprehensive Cancer Center, University of California, Irvine/US
  • 10 Medical Oncology, F. Hoffmann-La Roche, Basel/CH
  • 11 Multidisciplinary Oncology Center, Centre Hospitalier Universitaire Vaudois - CHUV, 1011 - Lausanne/CH


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Abstract 3850


We report mature PFS, updated OS and safety data from the global phase III ALEX study (NCT02075840) of ALC vs CRZ in patients (pts) with untreated ALK+ NSCLC after a further 12 months (m) of follow-up (cutoff date: 30 Nov 2018).


Eligible pts had stage IIIB/IV ALK+ NSCLC (by central IHC), ECOG PS 0–2 and no prior systemic therapy for advanced NSCLC. Asymptomatic CNS metastases (mets) were allowed. Pts were randomised 1:1 to twice-daily ALC 600mg (n = 152) or CRZ 250mg (n = 151). Primary endpoint: investigator (INV)-assessed PFS (RECIST v1.1), with q8w CNS imaging in all pts.


Mature, median INV-assessed PFS: 34.8 m (95% CI 17.7–NR) ALC vs 10.9 m (95% CI 9.1–12.9) CRZ (ITT stratified HR 0.43, 95% CI 0.32–0.58; p < 0.0001); pts with event, 53.3% ALC vs 80.8% CRZ. Median duration of follow-up: 37.8 m ALC vs 23.0 m CRZ. Median INV-assessed PFS was longer with ALC vs CRZ in pts with baseline (BL) CNS mets (25.4 m vs 7.4 m, respectively, HR 0.37, 95% CI 0.23–0.58) and in those without (38.6 m vs 14.8 m, respectively, HR 0.46, 95% CI 0.31–0.68). PFS event-free rate was higher with ALC vs CRZ regardless of BL CNS mets status, with 43.7% of ALC pts event-free at 4 years (Table). OS data remain immature (events: 32%; stratified HR 0.69, 95% CI 0.47–1.02). OS in pts with CNS mets at BL, HR 0.60 (95% CI 0.34–1.05) and in pts without CNS mets at BL, HR 0.77 (95% CI 0.45–1.32). The 4-year OS rate was 64.5% (95% CI 55.6–73.4) with ALC vs 52.2% (95% CI 42.6–64.8) with CRZ. Despite longer median treatment duration with ALC vs CRZ (27.7 m vs 10.8 m), the safety profile for ALC remains favourable; fewer ALC-treated pts experienced grade 3–5 AEs (48.7% vs 55.0% CRZ).Table:


PFS event-free rate, % (95% CI)OS event-free rate, % (95% CI)
ALC (n = 152)CRZ (n = 151)ALC (n = 152)CRZ (n = 151)
Duration (years)OverallBaseline CNS metsOverallBaseline CNS metsOverallOverall
167.8 (60.3–75.3)58.574.548.0 (39.7–56.2)32.557.284.3 (78.4–90.2)82.5 (76.1–88.9)
256.6 (48.6–64.6)52.059.824.8 (17.6–32.1)6.335.772.5 (65.1–79.9)65.1 (56.7–73.4)
346.4 (38.2–54.5)40.550.613.5 (7.7–19.3) (59.0–74.8)56.7 (47.8–65.6)
443.7 (35.4–51.9)38.047.6NE (NE–NE)NENE64.5 (55.6–73.4)52.2 (42.6–61.8)

NE, not estimable


This final updated PFS analysis confirms the superior efficacy and favourable tolerability of ALC compared with CRZ in pts with untreated ALK+ NSCLC. OS data remain immature (stratified HR 0.69, 95% CI 0.47–1.02), with a 4-year OS rate of 64.5% (95% CI 55.6–73.4) with ALC.

Clinical trial identification


Editorial acknowledgement

Nicola Griffin of Gardiner-Caldwell Communications; funded by F. Hoffmann-La Roche.

Legal entity responsible for the study

F. Hoffmann-La Roche Ltd.


F. Hoffmann-La Roche Ltd.


T.S.K. Mok: Leadership role: Sanonics Ltd.; Honoraria (self), Advisory / Consultancy: ACEA Biosciences, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Chimed, Cirina, Fishawack Facilitate, Ignyta, Janssen, Lilly, Merck Serono, Merck Sharp & Dohme, Novartis, OncoGenex, Pfizer, F. Hoffmann-La Roche Ltd/Genentech, SFJ Pharm; Research grant / Funding (self): AstraZeneca, Bristol-Myers Squibb, Clovis Oncology, Merck Sharp & Dohme, Novartis, Pfizer, F. Hoffmann-La Roche Ltd, SFJ Pharmaceutical and XCovery. A.T. Shaw: Honoraria (self), Advisory / Consultancy: F. Hoffmann-La Roche Ltd, Genentech, Pfizer, Novartis, Ariad, Ignyta, Daiichi-Sankyo, Taiho, Blueprint medicines, LOXO, EMD Serono and Foundation medicine. R.D. Camidge: Honoraria (self), Advisory / Consultancy: AbbVie, Ariad, Array, Celgene, Clovis Oncology, Eli Lilly, Genoptix, G1 Therapeutics, Novartis, Orion, and F. Hoffmann-La Roche Ltd/Genentech. S.M. Gadgeel: Honoraria (self), Advisory / Consultancy: Ariad, AstraZeneca, Bristol-Myers Squibb, Pfizer and F. Hoffmann-La Roche Ltd/Genentech. R. Dziadziuszko: Honoraria (self), Advisory / Consultancy: F. Hoffmann-La Roche Ltd, Pfizer, Boehringer Ingelheim, Clovis Oncology, Novartis, AstraZeneca and Tesaro. D. Kim: Travel / Accommodation / Expenses: F. Hoffmann-La Roche Ltd, Pfizer, Boehringer Ingelheim, Clovis Oncology, Novartis, AstraZeneca and Tesaro; Travel / Accommodation / Expenses: Novartis Oncology; Research grant / Funding (institution): Alpha Biopharma, AstraZeneca/MedImmune, Hanmi, Janssen, Merus, Mirati Therapeutics, MSD, Novartis, ONO Pharmaceutical, Pfizer, Roche/Genentech, Takeda, TP Therapeutics, Xcovery and Yuhan. M. Perol: Honoraria (self), Advisory / Consultancy: F. Hoffmann-La Roche Ltd/Genentech, Pfizer, Eli Lilly, Boehringer Ingelheim, Clovis Oncology, Merck Sharp & Dohme, Chugai, Bristol-Myers Squibb, Amgen, Novartis, Pierre Fabre, AstraZeneca, Takeda ; Research grant / Funding (institution): F. Hoffmann-La Roche Ltd, AstraZeneca, Chugai and Takeda. S. Ou: Honoraria (self): ARIAD, AstraZeneca, Pfizer, F. Hoffmann-La Roche Ltd/Genentech and TP Therapeutics; Speaker Bureau / Expert testimony: ARIAD, AstraZeneca and F. Hoffmann-La Roche Ltd/Genentech; Research grant / Funding (self): ARIAD, AstraZeneca, Daiichi Sankyo, Pfizer and F. Hoffmann-La Roche Ltd/Genentech; Shareholder / Stockholder / Stock options: TP Therapeutics. W. Bordogna: Full / Part-time employment: F. Hoffmann-La Roche Ltd. V. Smoljanović: Full / Part-time employment: F. Hoffmann-La Roche Ltd. M. Hilton: Full / Part-time employment: F. Hoffmann-La Roche Ltd. S. Peters: Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): AbbVie, Amgen, AstraZeneca, Bayer, Biocartis, Boehringer Ingelheim, Bristol-Myers Squibb, Clovis, Daiichi Sankyo, Debiopharm, Eli Lilly, F. Hoffmann-La Roche Ltd, Foundation Medicine, Illumina, Janssen, Merck Sharp and Dohme, Merck Serono, Merrimack, Nova. All other authors have declared no conflicts of interest.

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