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Clinically meaningful data for oral nintedanib in mesothelioma presented at World Conference on Lung Cancer
Date:12/7/2016

RIDGEFIELD, Conn., Dec. 7, 2016 /PRNewswire/ -- Boehringer Ingelheim today announced that the LUME-Meso Phase II trial in patients with unresectable malignant pleural mesothelioma (MPM) met its primary endpoint of progression-free survival (PFS). The data, presented at the 17th IASLC World Conference on Lung Cancer in Vienna, showed nintedanib plus pemetrexed/cisplatin demonstrated a meaningful clinical benefit compared to placebo plus pemetrexed/cisplatin, with a significantly improved PFS (9.4 vs 5.7 months). Preliminary overall survival (OS) data also favored nintedanib (18.3 vs 14.5 months).

Lead investigator, Professor Giorgio V. Scagliotti, University of Torino, Chair of the Department of Oncology, Italy, commented, "No targeted therapies are currently approved for the treatment of mesothelioma, a rare and difficult-to-treat cancer. The prognosis of MPM 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 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.

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%.

"Patients with malignant pleural mesothelioma and the physicians that care for them currently have very limited treatment options available to them," said Martina Flammer, M.D., 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 today represent an encouraging step towards developing targeted treatment options for patients with malignant pleural mesothelioma."

The LUME-Meso trial results were presented today (4:25 – 14:35 CET; 8:25 – 8:35 ET) as an oral presentation at the 17th IASLC World Conference on Lung Cancer 2016 in Vienna, Austria (Abstract ID #4191 #OA22.02).

About nintedanib
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) signalling 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.

About Boehringer Ingelheim in Oncology
Boehringer Ingelheim's oncology research is driven by a passion to advance clinical practice and a determination to improve the lives of patients who are battling cancer. Through our own scientific innovation and partnerships, we are focused on discovering and providing novel best-in-class, breakthrough cancer medications that fit the needs of patients, caregivers and healthcare professionals. We have a clear strategy to become a leader in the field of lung cancer. Boehringer Ingelheim has successfully launched two products globally for NSCLC that have been widely adopted and established as valuable additions to current clinical practice. Continuous insights and learnings from research and development are key parts of innovation and our way forward to advance clinical practice in lung cancer and other cancer types.

About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.

Boehringer Ingelheim is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 145 affiliates and more than 47,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.

Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families. Our employees create and engage in programs that strengthen our communities. To learn more about how we make more health for more people, visit our Corporate Social Responsibility Report.

In 2015, Boehringer Ingelheim achieved net sales of about $15.8 billion (14.8 billion euros). R&D expenditure corresponds to 20.3 percent of its net sales.

For more information please visit https://www.boehringer-ingelheim.us/, or follow us on Twitter @BoehringerUS.

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