12 Dec Mesothelioma: Nintedanib Plus Chemotherapy Demonstrated Improved Progression-Free Survival
MedicalResearch.com Interview with:
Professor Giorgio V. Scagliotti
Chair of the Department of Oncology
University of Torino,Italy
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: LUME-Meso II is an international study designed to evaluate the safety and efficacy of nintedanib plus pemetrexed/cisplatin, followed by nintedanib versus placebo plus pemetrexed/cisplatin, followed by placebo, for the treatment of patients with unresectable malignant pleural mesothelioma (MPM).
MPM is a rare cancer that affects the cells that make up the mesothelium of the pleura – the lining or membrane that covers and protects the lungs. It represents less than 1% of all cancers and is often related to long-term asbestos exposure with some suffering from malignant mesothelioma.
A significant improvement in progression-free survival (PFS), the study’s primary endpoint, was observed for patients receiving nintedanib plus chemotherapy compared to patients receiving placebo plus chemotherapy.
MedicalResearch.com: What should readers take away from your report?
Response: Data from the study, presented at the 17th IASLC World Conference on Lung Cancer in Vienna, showed that nintedanib plus pemetrexed/cisplatin demonstrated a meaningful clinical benefit compared to placebo plus pemetrexed/cisplatin, with a significantly improved progression-free survival (PFS) (9.4 vs 5.7 months). Preliminary overall survival (OS) data also favored nintedanib (18.3 vs 14.5 months).
The most common adverse events (? grade 3) occurring in nintedanib versus placebo patients were low concentration of neutrophils in the blood (neutropenia), 34% vs 10%; elevated liver enzymes, 14% vs 2%; and an increase in gamma glutamyltransferase, 14% vs 0%.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: A Phase III extension trial (LUME-Meso [NCT01907100]) is currently enrolling patients worldwide to continue evaluating nintedanib in this indication.
MedicalResearch.com: Is there anything else you would like to add?
Response: Nintedanib is an oral triple angiokinase inhibitor which simultaneously inhibits vascular endothelial growth factor receptors (VEGFR 1-3), platelet-derived growth factor receptors (PDGFR) and fibroblast growth factor receptors (FGFR 1-3) signaling pathways. These three different angiokinase receptors, which are not yet targeted by any currently available therapies, play an important role not only in angiogenesis but also in tumor growth and the development of metastases.
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Disclosure: Study supported by: Boehringer Ingelheim
Citation: 17th World Conference on Lung Cancer Dec 4 – 7, 2016
Nintedanib plus Pemetrexed/Cisplatin in Patients with MPM: Phase II Findings from the Placebo-Controlled LUME-Meso Trial
F. Grosso, N. Steele, S. Novello, A.K. Nowak, S. Popat, L. Greillier, T. John, N.B. Leighl, M. Reck, P. Taylor, N. Pavlakis, J.B. Sørensen, D. Planchard, G.L. Ceresoli, B. Hughes, J. Mazieres, M.A. Socinski, M. Mueller, U. Von Wangenheim, A.B. Loembe, N. Morsli, J. Barrueco, G.V. Scagliotti
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