Nintedanib granted orphan drug designation for treatment of mesothelioma

- Mesothelioma is a rare yet aggressive cancer associated with poor prognosis and limited treatment options

- Clinically meaningful Phase II data recently presented at the 17th IASLC World Conference on Lung Cancer

- Phase III trial (LUME-Meso) is currently recruiting patients at several U.S. sites

News provided by

Boehringer Ingelheim Pharmaceuticals, Inc.

Dec 14, 2016, 12:00 ET

RIDGEFIELD, Conn., Dec. 14, 2016 /PRNewswire/ -- Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to nintedanib for the treatment of mesothelioma. Orphan drug designation is granted by the FDA to investigational compounds intended for the safe and effective treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people.

Mesothelioma is a rare cancer that affects the lining or membrane (the mesothelium) that covers and protects organs in the body. Mesothelioma occurs most frequently in the cells lining the lungs, this is known as malignant pleural mesothelioma (MPM).

"Nintedanib, our triple angiokinase inhibitor, has shown promise as a potential treatment for malignant pleural mesothelioma in clinical trials to-date, and this designation is a validating milestone in its development," said Martina Flammer, M.D., Vice President, Clinical Development & Medical Affairs Specialty Care, Boehringer Ingelheim. "We are proud to receive this designation for nintedanib from the FDA, resulting from our ongoing commitment to researching potential treatment options for rare cancers such as mesothelioma."

Nintedanib was granted orphan drug designation based in part on data from the Phase II cohort of the ongoing Phase II/III LUME-Meso trial. LUME-Meso is an international, multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety profile of nintedanib plus chemotherapy (pemetrexed/cisplatin) followed by nintedanib monotherapy, versus placebo plus chemotherapy (pemetrexed/cisplatin) followed by placebo monotherapy, in patients with histologically confirmed, unresectable MPM.

Clinically meaningful results from the LUME-Meso Phase II trial in patients with unresectable MPM were recently presented in an oral session at the 17^th IASLC World Conference on Lung Cancer in Vienna on December 7^th. For more information, please see our press release here.

The Phase III LUME-Meso trial (NCT01907100) is currently recruiting patients worldwide. The Phase III portion of the trial plans to randomize 450 patients at 137 sites in 27 countries.

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.

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