Results of LUME-Meso trial in malignant pleural mesothelioma presented at the 19^th World Conference on Lung Cancer (WCLC 2018)

Ridgefield, Conn., September 25, 2018 – Boehringer Ingelheim today announced that the Phase III LUME-Meso trial did not meet its primary endpoint of progression-free survival (PFS) [NCT01907100]. In the LUME-Meso trial, patients with unresectable, epithelioid malignant pleural mesothelioma (MPM) were treated with nintedanib in combination with standard-of-care chemotherapy pemetrexed/cisplatin, compared to chemotherapy alone. Complete study results were presented as an oral presentation at the IASLC 19^th World Conference on Lung Cancer (WCLC 2018) and can be found here.

In the study, median PFS was 6.8 months in patients treated with nintedanib when added to chemotherapy, versus 7.0 months in the chemotherapy alone group (HR=1.01; 95% CI: 0.79–1.30; p=0.91). The observed side effects were consistent with previous trial experience and the known safety profile of nintedanib. In accordance with the study protocol, the trial was discontinued and study investigators and patients were informed.

Lead investigator Professor Giorgio V. Scagliotti, Chair of the Department of Oncology, University of Torino, Italy commented, “Malignant pleural mesothelioma (MPM) is a rare and difficult-to-treat cancer; it has a poor prognosis with a median survival of nine to 12 months from diagnosis. Developing therapies to treat MPM has proven to be very challenging for the scientific community. Data from the LUME-Meso study will provide valuable insights and information for researchers continuing to explore new advancements for treating the unmet needs of mesothelioma patients.”

Dr. Victoria Zazulina, Global Head of Solid Tumor Oncology, Medicine at Boehringer Ingelheim commented, “We are disappointed that the encouraging efficacy signal observed for nintedanib in Phase II was not confirmed in a larger Phase III trial, as there still remains a big gap in treatment options for patients with malignant pleural mesothelioma. We will ensure that the data and learnings generated from the LUME-Meso program are shared with the scientific community to guide future research and we remain dedicated to advancing our innovative cancer research program.”

About 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, epithelioid malignant pleural mesothelioma (MPM).

About nintedanib
Nintedanib is an oral triple angiokinase inhibitor that simultaneously inhibits vascular endothelial growth factor receptors (VEGFR 1-3), platelet-derived growth factor receptors (PDGFR) and fibroblast growth factor receptors (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.

About Boehringer Ingelheim in Oncology
Cancer takes away loved ones, time and untapped potential. At Boehringer Ingelheim we are providing new hope for patients by taking cancer on. We are collaborating with the oncology community to deliver scientific breakthroughs to transform the lives of patients. Our primary focus is in lung and gastrointestinal cancers, with the goal of delivering breakthrough, first-in-class treatments that can help win the fight against cancer. Our commitment to innovation has resulted in pioneering treatments for lung cancer and we are advancing a unique pipeline of cancer cell directed agents, immune oncology therapies and intelligent combination approaches to help combat many cancers.

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

Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Since its founding in 1885, the company has remained family-owned and today creates value through innovation for three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.

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. Please visit www.boehringer-ingelheim.us/csr to learn more about how we make more health through our Corporate Social Responsibility initiatives.

In 2017, Boehringer Ingelheim achieved net sales of about $20.4 billion (18.1 billion euros). R&D expenditure corresponds to approximately $3.4 billion (three billion euros), or 17.0 percent of its net sales.

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