• Mesothelioma is a rare and difficult-to-treat cancer with no targeted treatment options currently approved
• Oral triple angiokinase inhibitor nintedanib meets primary endpoint of progression-free survival (9.4 vs 5.7 months) and significantly reduced the risk of disease progression by 44% in Phase II study versus standard of care
• Phase III extension trial (LUME-Meso [NCT01907100]) is currently recruiting patients worldwide

INGELHEIM, Germany & VIENNA -- (BUSINESS WIRE) --

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 17^th 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, HR = 0.56 and p value =0.0174). Preliminary overall survival (OS) data also favoured nintedanib (18.3 vs 14.5 months, HR = 0.78 and p=0.4132).

Nintedanib (VARGATEF^®) in combination with docetaxel was approved in the EU in 2014 for use in adults with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy.

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%.

Dr. Victoria Zazulina, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim said, “Our oncology research is driven by a passion to advance clinical practice and a determination to improve the lives of patients who are battling cancer. Current treatment options for unresectable malignant pleural mesothelioma are limited and we are focussed on developing a targeted treatment option that will fit the needs of patients.”

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

* Nintedanib is approved in the EU under the brand name VARGATEF^® for use in combination with docetaxel in adult patients with locally advanced, metastatic or locally recurrent NSCLC of adenocarcinoma tumour histology after first-line chemotherapy. Nintedanib is under regulatory review by health authorities in other countries outside the EU. Nintedanib is not approved in other oncology indications.

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This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

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Boehringer Ingelheim
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Julia Knebel
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Email: press@boehringer-ingelheim.com