WCLC 2016: Phase II LUME-Meso Trial on Oral Nintedanib in Mesothelioma Demonstrates Meaningful Clinical Benefit
The LUME-Meso phase II trial in patients with unresectable malignant pleural mesothelioma met its primary endpoint of progression-free survival. The data, presented at the 17th IASLC World Conference on Lung Cancer (WCLC) in Vienna (Abstract 4191 #OA22.02), showed nintedanib (Ofev) plus pemetrexed/cisplatin demonstrated a meaningful clinical benefit compared to placebo plus pemetrexed/cisplatin, with a significantly improved progression-free survival (9.4 vs 5.7 months). Preliminary overall survival data also favored nintedanib (18.3 vs 14.5 months).
Based in part on data from the LUME-Meso trial, nintedanib was granted orphan drug designation for the treatment of mesothelioma by the U.S. Food and Drug Administration (FDA), which Boehringer Ingelheim announced earlier today.
Lead investigator, Giorgio V. Scagliotti, MD, PhD, Chair of the Department of Oncology at the University of Torino, Italy, commented, “No targeted therapies are currently approved for the treatment of mesothelioma, a rare and difficult-to-treat cancer. The prognosis of [malignant pleural mesothelioma] is poor, with a median survival of 9 to 12 months from diagnosis. We are very encouraged by these recent data; the results have led to an extension of the study into a phase III confirmatory trial that is now underway and will provide further insight into the potential of nintedanib for patients with [malignant pleural mesothelioma].”
The most common adverse events (≥ grade 3) occurring in nintedanib vs placebo patients were neutropenia, 34% vs 10%; elevated liver enzymes, 14% vs 2%; and an increase in gamma glutamyltransferase, 14% vs 0%.
“Patients with malignant pleural mesothelioma and the physicians that care for them currently have very limited treatment options available to them,” said Martina Flammer, MD, Vice President Clinical Development and Medical Affairs Specialty Care, Boehringer Ingelheim. “Nintedanib is a novel agent that inhibits signaling pathways not targeted by other available therapies, and the data presented…represent an encouraging step towards developing targeted treatment options for patients with malignant pleural mesothelioma.”
About Nintedanib
Nintedanib is an oral triple angiokinase inhibitor that simultaneously inhibits vascular endothelial growth factor receptor (VEGFR 1–3), platelet-derived growth factor receptor (PDGFR), and fibroblast growth factor receptor (FGFR 1–3) signaling pathways. These three different angiokinase receptors play an important role not only in angiogenesis, but also in tumor growth and the development of metastases.
Nintedanib was approved by the FDA in 2014 for the treatment of idiopathic pulmonary fibrosis.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
