• The trial will evaluate efficacy and safety of nintedanib* as a first-line oral treatment in combination with pemetrexed/cisplatin followed by continuing nintedanib monotherapy
• Nintedanib targets receptors that play a role in tumour growth and development of metastasis in malignant pleural mesothelioma where no other targeted therapies are currently approved
• Follows EU approval of nintedanib (Vargatef^®) in combination with docetaxel for treatment of adenocarcinoma of the lung after first-line chemotherapy

INGELHEIM, Germany -- (BUSINESS WIRE) --

Boehringer Ingelheim today announced the enrolment of the first patient in the global Phase III trial evaluating the efficacy and safety of nintedanib in combination with pemetrexed/cisplatin, followed by continuing nintedanib monotherapy, as a first-line treatment for patients with unresectable malignant pleural mesothelioma (MPM). Patients will qualify for enrolment in the trial if they are not eligible to undergo surgical resection, have received no prior first-line therapies for MPM and hold an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Lead investigator, Professor Giorgio V. Scagliotti, Chair of the Department of Oncology, University of Torino, Italy, commented, “Malignant pleural mesothelioma is a rare cancer and despite years of research, patients continue to have a poor prognosis – less than 10% survive for five years following diagnosis. Due to the mode of action of nintedanib, it has the potential to be an effective treatment option for patients with pleural mesothelioma.”

LUME-Meso [NCT01907100] will randomise 397 patients in a double-blind, multi-centre, global comparison of nintedanib in combination with pemetrexed/cisplatin or matching placebo in combination with pemetrexed/cisplatin as a first-line treatment. For patients whose disease has not progressed after a maximum of six cycles of chemotherapy, nintedanib or matching placebo will continue to be administered orally as a monotherapy on a daily basis, until disease progression or unmanageable side effects. The primary endpoint of the trial is progression-free survival and overall survival is the key secondary endpoint. Other secondary endpoints include objective tumour response and disease control.

Through its mode of action nintedanib targets the receptors of the vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), platelet-derived growth factor (PDGF) and proto-oncogene tyrosine-protein kinase (Src) pathways which play a role in tumour growth and the development of metastasis in MPM. No targeted therapies are currently approved for the treatment of this rare and difficult-to-treat cancer.

Dr Jörg Barth, Corporate Senior Vice President, Therapy Area Head Oncology, Boehringer Ingelheim said, “Over the last few years Boehringer Ingelheim has accumulated considerable expertise in the field of thoracic oncology. With the approval of Giotrif^® and Vargatef^® as well as a broad clinical pipeline we are building up a strong presence in this setting. The effort to develop a potential efficacious treatment for malignant pleural mesothelioma demonstrates our long-term commitment for patients with significant unmet medical need.”

Nintedanib is also being evaluated in the LUME-Colon 1 trial [NCT02149108], a global Phase III trial in patients with advanced colorectal cancer. Recruitment is now complete and data are expected to be available later in 2016.

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.

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* 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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