Journal article
Ceritinib plus Nivolumab in Patients with Advanced ALK-Rearranged Non–Small Cell Lung Cancer: Results of an Open-Label, Multicenter, Phase 1B Study
E Felip, FG de Braud, M Maur, HH Loong, AT Shaw, JF Vansteenkiste, T John, G Liu, MP Lolkema, G Selvaggi, V Giannone, P Cazorla, J Baum, OA Balbin, L Wang, YY Lau, JW Scott, DSW Tan
Journal of Thoracic Oncology | Published : 2020
Abstract
Introduction: Induction of programmed death ligand 1 (PD-L1) expression due to constitutive oncogenic signaling has been reported in NSCLC models harboring echinoderm microtubule associated protein like 4 gene (EML4)–ALK receptor tyrosine kinase gene (ALK) rearrangements. We assessed the safety and activity of ceritinib plus nivolumab in these patients. Methods: In this open-label, phase 1B, multicenter, dose escalation and expansion study, previously treated (with ALK receptor tyrosine kinase [ALK] inhibitor [ALKI]/chemotherapy) or treatment-naive patients with stage IIIB or IV ALK-rearranged NSCLC received nivolumab, 3 mg/kg intravenously every 2 weeks, plus ceritinib, 450 mg/300 mg daily,..
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Funding Acknowledgements
This study was funded by Novartis Pharmaceuticals Corporation. We thank Pushkar Narvilkar (Novartis Healthcare Pvt. Ltd., Hyderabad, India) for providing medical editorial assistance with this article. Drs. Maur, Shaw, Vansteenkiste, John, Liu, Selvaggi, Lau, Scott, and Tan contributed to study design. Drs. Lolkema, Selvaggi, Giannone, and Scott contributed to study execution. Dr. Cazorla contributed to oversight of study conduct and data monitoring. Drs. Felip, de Braud, Maur, Loong, Shaw, Vansteenkiste, John, Liu, Lolkema, Selvaggi, and Tan recruited patients and contributed to data collection. Drs. Felip, Loong, Shaw, Vansteenkiste, John, Liu, Lolkema, Selvaggi, Giannone, Cazorla, Lau, Scott, and Tan contributed to data analysis and interpretation. Dr. Baum contributed to biomarker testing and analysis (programmed death ligand 1 and circulating tumor DNA) and data interpretation. Dr. Balbin performed bioinformatics and correlative analysis for the cell free DNA sequencing data. Dr. Wang contributed to planning, conducting, and interpreting statistical analysis. Dr. Lau contributed to pharmacokinetic and pharmacodynamics data analysis and interpretation. Dr. Felip wrote the first draft of the article with the help of a medical writer. All authors provided input for data interpretation, critically revised the content, and approved the final draft of the article for publication. Novartis will not provide access to patient-level data if there is a reasonable likelihood that individual patients could be reidentified. Phase 1 studies, by their nature, present a high risk of patient reidentification; therefore, patient individual results for phase 1 studies cannot be shared. In addition, clinical data, in some cases, have been collected subject to contractual or consent provisions that prohibit transfer to third parties. Such restrictions may preclude granting access under these provisions. Where codevelopment agreements or other legal restrictions prevent companies from sharing particular data, companies will work with qualified requestors to provide summary information where possible.