Alectinib versus Crizotinib in Untreated ALK -Positive Non–Small-Cell Lung Cancer
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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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Duration of response, progression-free survival, and overall survival are even more variable across these trials.
“Even more variable are duration of response to targeted therapy, progression-free survival and overall survival16–26, 28–32, 35.”
From Co-occurring genomic alterations in non-small-cell lung cancer biology and therapy (2019) · cites this paper as [23]
The low frequency of co-drivers plus marked dependence on the ALK fusion protein could account for prolonged PFS seen with second- and third-generation ALK inhibitors.
“both the rarity of co-drivers and strong addiction to the ALK fusion oncoprotein may account for the long progression-free survival observed in patients with ALK-rearrangements with the potent and selective second and third generation ALK inhibitors alectinib, brigatinib and lorlatinib23, 26, 27.”
From Co-occurring genomic alterations in non-small-cell lung cancer biology and therapy (2019) · cites this paper as [23]
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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
- 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
- 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 · 2016: 1
- 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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