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Alectinib versus Crizotinib in Untreated ALK -Positive Non–Small-Cell Lung Cancer

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Peters, Solange, Camidge, D. Ross, Shaw, Alice T., Gadgeel, Shirish, Ahn, Jin S., Kim, Dong-Wan, Ou, Sai-Hong I., Pérol, Maurice, Dziadziuszko, Rafal, Rosell, Rafael, Zeaiter, Ali, Mitry, Emmanuel, Golding, Sophie, Balas, Bogdana, Noe, Johannes, Morcos, Peter N., Mok, Tony·2017·New England Journal of Medicine

DOI 10.1056/nejmoa1704795

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Abstract

BACKGROUND: Alectinib, a highly selective inhibitor of anaplastic lymphoma kinase (ALK), has shown systemic and central nervous system (CNS) efficacy in the treatment of ALK-positive non-small-cell lung cancer (NSCLC). We investigated alectinib as compared with crizotinib in patients with previously untreated, advanced ALK-positive NSCLC, including those with asymptomatic CNS disease. METHODS: In a randomized, open-label, phase 3 trial, we randomly assigned 303 patients with previously untreated, advanced ALK-positive NSCLC to receive either alectinib (600 mg twice daily) or crizotinib (250 mg twice daily). The primary end point was investigator-assessed progression-free survival. Secondary end points were independent review committee-assessed progression-free survival, time to CNS progression, objective response rate, and overall survival. RESULTS: During a median follow-up of 17.6 months (crizotinib) and 18.6 months (alectinib), an event of disease progression or death occurred in 62 of 152 patients (41%) in the alectinib group and 102 of 151 patients (68%) in the crizotinib group. The rate of investigator-assessed progression-free survival was significantly higher with alectinib than with crizotinib (12-month event-free survival rate, 68.4% [95% confidence interval (CI), 61.0 to 75.9] with alectinib vs. 48.7% [95% CI, 40.4 to 56.9] with crizotinib; hazard ratio for disease progression or death, 0.47 [95% CI, 0.34 to 0.65]; P<0.001); the median progression-free survival with alectinib was not reached. The results for independent review committee-assessed progression-free survival were consistent with those for the primary end point. A total of 18 patients (12%) in the alectinib group had an event of CNS progression, as compared with 68 patients (45%) in the crizotinib group (cause-specific hazard ratio, 0.16; 95% CI, 0.10 to 0.28; P<0.001). A response occurred in 126 patients in the alectinib group (response rate, 82.9%; 95% CI, 76.0 to 88.5) and in 114 patients in the crizotinib group (response rate, 75.5%; 95% CI, 67.8 to 82.1) (P=0.09). Grade 3 to 5 adverse events were less frequent with alectinib (41% vs. 50% with crizotinib). CONCLUSIONS: As compared with crizotinib, alectinib showed superior efficacy and lower toxicity in primary treatment of ALK-positive NSCLC. (Funded by F. Hoffmann-La Roche; ALEX ClinicalTrials.gov number, NCT02075840 .).

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Authors: Peters, S., Camidge, D. R., Shaw, A. T., Gadgeel, S., Ahn, J. S., Kim, D.-W., Ou, S.-H. I., Pérol, M., Dziadziuszko, R., Rosell, R., Zeaiter, A., Mitry, E., Golding, S., Balas, B., Noe, J., Morcos, P. N., & Mok, T.
Affiliations: F. Hoffmann-La Roche AG (CH)
ORCID: Peters, Solange
Camidge, D. Ross
Shaw, Alice T.
Gadgeel, Shirish
Ahn, Jin S.
Kim, Dong-Wan
Ou, Sai-Hong I.
Rosell, Rafael
Mitry, Emmanuel
Balas, Bogdana
Morcos, Peter N.
Mok, Tony
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2017-08-31
Volume: 377
Issue: 9
Pages: 829-838
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1704795
OpenAlex: W2624310346
Cited by: 2,527
References: 14
Citations by year: 2026: 173 · 2025: 216 · 2024: 260 · 2023: 270 · 2022: 306 · 2021: 336 · 2020: 327 · 2019: 276 · 2018: 277 · 2017: 82
FWCI: 218.03
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
SERVAL (Université de Lausanne) (publishedVersion, other-oa)
Dipòsit Digital de Documents de la UAB (Universitat Autònoma de Barcelona) (submittedVersion, public-domain)
IRIS (submittedVersion)
LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, public-domain)
Seoul National University Open Repository (Seoul National University) (submittedVersion)
Funders: Amgen
Bristol-Myers Squibb
Eli Lilly and Company
Pfizer
AstraZeneca
Ariad Pharmaceuticals
Celgene
F. Hoffmann-La Roche
Array BioPharma
Regeneron Pharmaceuticals
Taiho Pharmaceutical
Les Laboratories Pierre Fabre
Clovis Oncology
G1 Therapeutics
Eisai
Genentech
EMD Serono
Ignyta
Loxo Oncology
Foundation Medicine
Daiichi Sankyo Europe
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Keywords: alectinib, crizotinib, anaplastic lymphoma kinase, ALK-positive non-small cell lung cancer, ALK inhibitors, progression-free survival, CNS progression, central nervous system metastasis, objective response rate, overall survival, first-line therapy, targeted therapy, head-to-head comparison
MeSH terms: Crizotinib, Anaplastic Lymphoma Kinase, Adult, Aged, 80 and over, Animals, Antineoplastic Agents, Carbazoles, Carcinoma, Non-Small-Cell Lung, Female, Follow-Up Studies, Humans, Lung Neoplasms, Male, Middle Aged, Piperidines, Pyrazoles, Pyridines, Central Nervous System Neoplasms, Disease-Free Survival, Receptor Protein-Tyrosine Kinases, Protein Kinase Inhibitors, Kaplan-Meier Estimate, Young Adult, Intention to Treat Analysis

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Alectinib versus Crizotinib in Untreated ALK -Positive Non–Small-Cell Lung Cancer

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