Activity and safety of ceritinib in patients with ALK-rearranged non-small-cell lung cancer (ASCEND-1): updated results from the multicentre, open-label, phase 1 trial.

PubWeight™: 1.90‹?› | Rank: Top 3%

🔗 View Article (PMID 26973324)

Published in Lancet Oncol on March 11, 2016

Authors

Dong-Wan Kim1, Ranee Mehra2, Daniel S W Tan3, Enriqueta Felip4, Laura Q M Chow5, D Ross Camidge6, Johan Vansteenkiste7, Sunil Sharma8, Tommaso De Pas9, Gregory J Riely10, Benjamin J Solomon11, Jürgen Wolf12, Michael Thomas13, Martin Schuler14, Geoffrey Liu15, Armando Santoro16, Santosh Sutradhar17, Siyu Li17, Tomasz Szczudlo17, Alejandro Yovine18, Alice T Shaw19

Author Affiliations

1: Seoul National University Hospital, Seoul, Korea.
2: Fox Chase Cancer Center, Philadelphia, PA, USA.
3: National Cancer Center, Singapore, Singapore.
4: Vall d'Hebron University, Barcelona, Spain.
5: University of Washington, Seattle, WA, USA.
6: University of Colorado, Denver, CO, USA.
7: University Hospital KU Leuven, Leuven, Belgium.
8: Huntsman Cancer Institute, Salt Lake City, UT, USA.
9: Istituto Europeo di Oncologia, Milan, Italy.
10: Memorial Sloan Kettering Cancer Center, New York, NY, USA.
11: Peter MacCallum Cancer Center, Melbourne, VIC, Australia.
12: Centre for Integrated Oncology, University Hospital Cologne, Cologne, Germany.
13: Internistische Onkologie der Thoraxtumoren, Thoraxklinik im Universitätsklinikum Heidelberg, Translational Lung Research Center Heidelberg (TLRC-H), Member of the German Center for Lung Research (DZL), Heidelberg, Germany.
14: University Hospital Essen, University Duisburg-Essen, German Cancer Consortium (DKTK), Partner site University Hospital Essen, Essen, Germany.
15: Princess Margaret Cancer Center, Toronto, ON, Canada.
16: IRCCS Institute Clinico Humanitas, Milan, Italy.
17: Novartis Pharma, East Hanover, NJ, USA.
18: Novartis Pharma AG, Basel, Switzerland.
19: Massachusetts General Hospital, Boston, MA, USA. Electronic address: ashaw1@partners.org.

Associated clinical trials:

A Dose Escalation/Expansion Study of LDK378 in Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase | NCT01283516

A Phase II Study to Evaluate the Efficacy and Safety of Oral Ceritinib in Patients With ALK-positive NSCLC Metastatic to the Brain and/or to Leptomeninges (Ascend-7) | NCT02336451

Articles citing this

Molecular Mechanisms of Resistance to First- and Second-Generation ALK Inhibitors in ALK-Rearranged Lung Cancer. Cancer Discov (2016) 1.26

Emerging therapeutic agents for lung cancer. J Hematol Oncol (2016) 0.88

Updates in the management of brain metastases. Neuro Oncol (2016) 0.88

Recent Advances in Targetable Therapeutics in Metastatic Non-Squamous NSCLC. Front Oncol (2016) 0.79

Overall survival with crizotinib and next-generation ALK inhibitors in ALK-positive non-small-cell lung cancer (IFCT-1302 CLINALK): a French nationwide cohort retrospective study. Oncotarget (2017) 0.78

ALK alterations and inhibition in lung cancer. Semin Cancer Biol (2016) 0.78

Targeting ALK: Precision Medicine Takes on Drug Resistance. Cancer Discov (2017) 0.78

Precision medicine in lung cancer: the battle continues. J Thorac Dis (2016) 0.78

Resisting Resistance: Targeted Therapies in Lung Cancer. Trends Cancer (2016) 0.77

Clinical outcomes in ALK-rearranged lung adenocarcinomas according to ALK fusion variants. J Transl Med (2016) 0.77

A Case of Metastatic Atypical Neuroendocrine Tumor with ALK Translocation and Diffuse Brain Metastases. Oncologist (2017) 0.77

The steady progress of targeted therapies, promising advances for lung cancer. Ecancermedicalscience (2016) 0.76

Tackling ALK in non-small cell lung cancer: the role of novel inhibitors. Transl Lung Cancer Res (2016) 0.76

Focus on Alectinib and Competitor Compounds for Second-Line Therapy in ALK-Rearranged NSCLC. Front Med (Lausanne) (2016) 0.75

Achievements and future developments of ALK-TKIs in the management of CNS metastases from ALK-positive NSCLC. Transl Lung Cancer Res (2016) 0.75

A large, single-center, real-world study of clinicopathological characteristics and treatment in advanced ALK-positive non-small-cell lung cancer. Cancer Med (2017) 0.75

Personalized treatment in advanced ALK-positive non-small cell lung cancer: from bench to clinical practice. Onco Targets Ther (2016) 0.75

Ceritinib for non-small cell lung cancer. Aust Prescr (2017) 0.75

The activity, safety, and evolving role of brigatinib in patients with ALK-rearranged non-small cell lung cancers. Onco Targets Ther (2017) 0.75

Current evidence in support of the second-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor alectinib for the treatment of non-small cell lung cancer positive for ALK translocation. J Thorac Dis (2016) 0.75

ASCEND-2: a canary in a coal mine for descending to second-line treatment for ALK-rearranged non-small cell lung cancer. Transl Lung Cancer Res (2016) 0.75

ALK gene copy number gains in non-small-cell lung cancer: prognostic impact and clinico-pathological correlations. Respir Res (2016) 0.75

Fusion gene and splice variant analyses in liquid biopsies of lung cancer patients. Transl Lung Cancer Res (2016) 0.75

ASCENDing the anaplastic lymphoma kinase ladder: a tale of two C-nibs. J Thorac Dis (2016) 0.75

Crizotinib resistance: implications for therapeutic strategies. Ann Oncol (2016) 0.75

Is there a benefit of first- or second-line crizotinib in locally advanced or metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer? a meta-analysis. Oncotarget (2016) 0.75

Are immune checkpoint blockade monoclonal antibodies active against CNS metastases from NSCLC?-current evidence and future perspectives. Transl Lung Cancer Res (2016) 0.75

Second-generation anaplastic lymphoma kinase inhibitors: revolutionary or evolutionary? J Thorac Dis (2016) 0.75

Sequencing ALK inhibitors: alectinib in crizotinib-resistant patients, a phase 2 trial by Shaw et al. J Thorac Dis (2016) 0.75

Ceritinib in second and further lines of therapy in advanced ALK mutant adenocarcinoma. J Thorac Dis (2016) 0.75

Systemic therapy for echinoderm microtubule-associated protein-like 4 anaplastic lymphoma kinase non-small cell lung cancer brain metastases. J Thorac Dis (2016) 0.75

Update on targeted therapies for advanced non-small cell lung cancer: nivolumab in context. Ther Clin Risk Manag (2017) 0.75

ALK: a tyrosine kinase target for cancer therapy. Cold Spring Harb Mol Case Stud (2017) 0.75

Systemic therapy of brain metastases: non-small cell lung cancer, breast cancer, and melanoma. Neuro Oncol (2017) 0.75

The Emerging Role of Targeted Therapy and Immunotherapy in the Management of Brain Metastases in Non-Small Cell Lung Cancer. Front Oncol (2017) 0.75

Editorial on the article entitled "brigatinib efficacy and safety in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer in a phase I/II trial". J Thorac Dis (2016) 0.75

Meta-analysis of the incidence and risks of interstitial lung disease and QTc prolongation in non-small-cell lung cancer patients treated with ALK inhibitors. Oncotarget (2017) 0.75

What is the optimal first-line treatment for advanced anaplastic lymphoma kinase-rearranged non-small cell lung cancer? J Thorac Dis (2017) 0.75

The between Now and Then of Lung Cancer Chemotherapy and Immunotherapy. Int J Mol Sci (2017) 0.75

Review of the use of pretest probability for molecular testing in non-small cell lung cancer and overview of new mutations that may affect clinical practice. Ther Adv Med Oncol (2017) 0.75

Multiple receptor tyrosine kinase activation related to ALK inhibitor resistance in lung cancer cells with ALK rearrangement. Oncotarget (2017) 0.75

Recent Advances in Targeting ROS1 in Lung Cancer. J Thorac Oncol (2017) 0.75

Biopsy and re-biopsy in lung cancer: the oncologist requests and the role of endobronchial ultrasounds transbronchial needle aspiration. J Thorac Dis (2017) 0.75

Articles cited by this

Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med (2010) 36.78

Acquired resistance of lung adenocarcinomas to gefitinib or erlotinib is associated with a second mutation in the EGFR kinase domain. PLoS Med (2005) 25.93

Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer. J Clin Oncol (2008) 17.30

Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med (2013) 14.78

First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med (2014) 10.91

Ceritinib in ALK-rearranged non-small-cell lung cancer. N Engl J Med (2014) 9.94

Activity and safety of crizotinib in patients with ALK-positive non-small-cell lung cancer: updated results from a phase 1 study. Lancet Oncol (2012) 8.64

Mechanisms of acquired crizotinib resistance in ALK-rearranged lung Cancers. Sci Transl Med (2012) 8.41

Crizotinib in ROS1-rearranged non-small-cell lung cancer. N Engl J Med (2014) 6.95

Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs. JAMA (2014) 6.32

Mechanisms of resistance to crizotinib in patients with ALK gene rearranged non-small cell lung cancer. Clin Cancer Res (2012) 6.23

Safety and activity of alectinib against systemic disease and brain metastases in patients with crizotinib-resistant ALK-rearranged non-small-cell lung cancer (AF-002JG): results from the dose-finding portion of a phase 1/2 study. Lancet Oncol (2014) 4.32

Acquired resistance to epidermal growth factor receptor tyrosine kinase inhibitors in non-small-cell lung cancers dependent on the epidermal growth factor receptor pathway. Clin Lung Cancer (2009) 3.37

The ALK inhibitor ceritinib overcomes crizotinib resistance in non-small cell lung cancer. Cancer Discov (2014) 3.31

CSF concentration of the anaplastic lymphoma kinase inhibitor crizotinib. J Clin Oncol (2011) 3.00

Local ablative therapy of oligoprogressive disease prolongs disease control by tyrosine kinase inhibitors in oncogene-addicted non-small-cell lung cancer. J Thorac Oncol (2012) 2.47

Clinical Experience With Crizotinib in Patients With Advanced ALK-Rearranged Non-Small-Cell Lung Cancer and Brain Metastases. J Clin Oncol (2015) 2.26

Clinical benefit of continuing ALK inhibition with crizotinib beyond initial disease progression in patients with advanced ALK-positive NSCLC. Ann Oncol (2014) 1.97

Activation of HER family signaling as a mechanism of acquired resistance to ALK inhibitors in EML4-ALK-positive non-small cell lung cancer. Clin Cancer Res (2012) 1.71

U.S. Food and Drug Administration approval: crizotinib for treatment of advanced or metastatic non-small cell lung cancer that is anaplastic lymphoma kinase positive. Clin Cancer Res (2014) 1.12

Brain metastases in patients with EGFR-mutated or ALK-rearranged non-small-cell lung cancers. Lung Cancer (2015) 1.06

CSF Concentration of Crizotinib in Two ALK-Positive Non-Small-Cell Lung Cancer Patients with CNS Metastases Deriving Clinical Benefit from Treatment. J Thorac Oncol (2015) 1.01

Biology of brain metastases and novel targeted therapies: time to translate the research. Biochim Biophys Acta (2012) 0.96

On the merits and limitations of whole-brain radiation therapy. J Clin Oncol (2012) 0.93

Managing treatment-related adverse events associated with Alk inhibitors. Curr Oncol (2014) 0.93

Alectinib: a novel second generation anaplastic lymphoma kinase (ALK) inhibitor for overcoming clinically-acquired resistance. Acta Pharm Sin B (2015) 0.86

Brain metastases in non-small-cell lung cancer: better outcomes through current therapies and utilization of molecularly targeted approaches. CNS Oncol (2014) 0.81

Articles by these authors

Safety and activity of alectinib against systemic disease and brain metastases in patients with crizotinib-resistant ALK-rearranged non-small-cell lung cancer (AF-002JG): results from the dose-finding portion of a phase 1/2 study. Lancet Oncol (2014) 4.32

Alectinib in ALK-positive, crizotinib-resistant, non-small-cell lung cancer: a single-group, multicentre, phase 2 trial. Lancet Oncol (2015) 2.60

Efficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma: pooled analyses after long-term follow-up in KEYNOTE-012. Br J Cancer (2018) 1.39

Safety and activity of pembrolizumab in patients with locally advanced or metastatic urothelial cancer (KEYNOTE-012): a non-randomised, open-label, phase 1b study. Lancet Oncol (2017) 0.85

Ceritinib in patients with advanced anaplastic lymphoma kinase-rearranged anaplastic large-cell lymphoma. Blood (2015) 0.81

A phase 1 study combining the HER3 antibody seribantumab (MM-121) and cetuximab with and without irinotecan. Invest New Drugs (2016) 0.75

A phase I open-label dose-escalation study of the anti-HER3 monoclonal antibody LJM716 in patients with advanced squamous cell carcinoma of the esophagus or head and neck and HER2-overexpressing breast or gastric cancer. BMC Cancer (2017) 0.75

Crizotinib Versus Chemotherapy in Asian Patients with Advanced ALK-positive Non-small Cell Lung Cancer. Cancer Res Treat (2017) 0.75

The accelerated path of ceritinib: Translating pre-clinical development into clinical efficacy. Cancer Treat Rev (2017) 0.75