Ceritinib in ALK -Rearranged Non–Small-Cell Lung Cancer
Open accessAbstract
BACKGROUND: Non-small-cell lung cancer (NSCLC) harboring the anaplastic lymphoma kinase gene (ALK) rearrangement is sensitive to the ALK inhibitor crizotinib, but resistance invariably develops. Ceritinib (LDK378) is a new ALK inhibitor that has shown greater antitumor potency than crizotinib in preclinical studies. METHODS: In this phase 1 study, we administered oral ceritinib in doses of 50 to 750 mg once daily to patients with advanced cancers harboring genetic alterations in ALK. In an expansion phase of the study, patients received the maximum tolerated dose. Patients were assessed to determine the safety, pharmacokinetic properties, and antitumor activity of ceritinib. Tumor biopsies were performed before ceritinib treatment to identify resistance mutations in ALK in a group of patients with NSCLC who had had disease progression during treatment with crizotinib. RESULTS: A total of 59 patients were enrolled in the dose-escalation phase. The maximum tolerated dose of ceritinib was 750 mg once daily; dose-limiting toxic events included diarrhea, vomiting, dehydration, elevated aminotransferase levels, and hypophosphatemia. This phase was followed by an expansion phase, in which an additional 71 patients were treated, for a total of 130 patients overall. Among 114 patients with NSCLC who received at least 400 mg of ceritinib per day, the overall response rate was 58% (95% confidence interval [CI], 48 to 67). Among 80 patients who had received crizotinib previously, the response rate was 56% (95% CI, 45 to 67). Responses were observed in patients with various resistance mutations in ALK and in patients without detectable mutations. Among patients with NSCLC who received at least 400 mg of ceritinib per day, the median progression-free survival was 7.0 months (95% CI, 5.6 to 9.5). CONCLUSIONS: Ceritinib was highly active in patients with advanced, ALK-rearranged NSCLC, including those who had had disease progression during crizotinib treatment, regardless of the presence of resistance mutations in ALK. (Funded by Novartis Pharmaceuticals and others; ClinicalTrials.gov number, NCT01283516.).
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In the group of 80 patients who had received crizotinib in the Shaw et al report, median PFS was 6.9 months (95% CI, 5.3 to 8.8).
“In the group of 80 patients who had received crizotinib, median PFS was 6.9 months (95% CI, 5.3 to 8.8).”
From Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update (2015) · cites this paper as [42]
At the subsequently approved dose of 750 mg once daily, the response rate with ceritinib was 59% (95% CI, 47 to 70).
“At the subsequently approved dose of 750 mg once daily, the response rate was 59% (95% CI, 47 to 70).”
From Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update (2015) · cites this paper as [42]
In an interim analysis of the Shaw et al report, 12-month OS was 65% for all participants.
“In an interim analysis, 12-month OS was 65% for all participants.42”
From Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update (2015) · cites this paper as [42]
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- Authors
- Shaw, A. T., Kim, D.-W., Mehra, R., Tan, D. S. W., Felip, E., Chow, L. Q. M., Camidge, D. R., Vansteenkiste, J., Sharma, S., De Pas, T., Riely, G. J., Solomon, B. J., Wolf, J., Thomas, M., Schuler, M., Liu, G., Santoro, A., Lau, Y. Y., Goldwasser, M., Boral, A. L., & Engelman, J. A.
- Affiliations
- Fox Chase Cancer Center (US)
- Seoul National University Hospital (KR)
- National Cancer Centre Singapore (SG)
- University of Washington (US)
- University of Colorado Denver (US)
- KU Leuven (BE)
- Huntsman Cancer Institute (US)
- Memorial Sloan Kettering Cancer Center (US)
- Peter MacCallum Cancer Centre (AU)
- University Hospital Cologne (DE)
- Heidelberg University (DE)
- Princess Margaret Cancer Centre (CA)
- Massachusetts General Hospital (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2014-03-27
- Volume
- 370
- Issue
- 13
- Pages
- 1189-1197
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC4079055
- OpenAlex
- W1974903221
- Cited by
- 1,495
- References
- 26
- Citations by year
- 2026: 13 · 2025: 42 · 2024: 31 · 2023: 64 · 2022: 87 · 2021: 70 · 2020: 93 · 2019: 109 · 2018: 141 · 2017: 222 · 2016: 242 · 2015: 261 · 2014: 118 · 2013: 2
- FWCI
- 226.56
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Kölner Universitäts PublikationsServer (Universität zu Köln) (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Universitätsbibliographie, Universität Duisburg-Essen (submittedVersion)
- Lirias (KU Leuven) (submittedVersion)
- Seoul National University Open Repository (Seoul National University) (submittedVersion)
- Funders
- National Cancer Institute (R01CA164273)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
- Keywords
- ceritinib, ALK rearrangement, non-small cell lung cancer, ALK inhibitors, crizotinib resistance, ALK resistance mutations, maximum tolerated dose, pharmacokinetics, anticancer activity, progression-free survival, dose-limiting toxicity, hypophosphatemia, diarrhea, aminotransferase elevation, overall response rate
- MeSH terms
- Anaplastic Lymphoma Kinase, Adult, Aged, Aged, 80 and over, Carcinoma, Non-Small-Cell Lung, Female, Humans, Lung Neoplasms, Male, Middle Aged, Pyrimidines, Recombination, Genetic, Sulfones, Treatment Outcome, Drug Resistance, Neoplasm, Maximum Tolerated Dose, Receptor Protein-Tyrosine Kinases, Protein Kinase Inhibitors, Young Adult
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