Encouraging Phase II survival data for oral nintedanib in malignant pleural mesothelioma presented at ASCO 2017

Ridgefield, Conn., June 5, 2017 – Boehringer Ingelheim today announced that Phase II results from LUME-Meso, a randomized, double-blind, placebo-controlled trial, have been presented as part of an Oral Abstract Session at the 2017 Annual Meeting of the American Society of Clinical Oncology (ASCO). Nintedanib, an oral triple angiokinase inhibitor, demonstrated improved progression-free survival (PFS, primary endpoint) and overall survival (OS, secondary endpoint) when added to standard first-line chemotherapy of pemetrexed/cisplatin in patients with malignant pleural mesothelioma (MPM) compared to chemotherapy alone.

MPM is a rare thoracic cancer, representing less than 1% of all cancers, and is often related to long-term asbestos exposure. MPM patients have a poor prognosis, with less than 10% surviving for five years following diagnosis. MPM is broadly categorized by cell type, or histology, in three subtypes (epithelioid, biphasic and sarcomatoid), with epithelioid being the most common, accounting for 50%-70% of all diagnoses.

The updated Phase II PFS results from the LUME-Meso study showed nintedanib 200 mg administered twice daily, when added to standard chemotherapy, nearly halved the risk of disease progression. A 46% reduction was demonstrated, with a significant improvement in median PFS of 3.7 months (9.4 vs. 5.7 months) in the overall study population (patients with either an epithelioid or biphasic cell type) compared to placebo plus standard chemotherapy alone. In patients with an epithelioid cell type, nintedanib plus chemotherapy demonstrated a greater median PFS benefit of 4 months (9.7 vs. 5.7 months).

The primary OS analysis showed an encouraging 4.1 month improvement in the median OS for patients receiving nintedanib in addition to chemotherapy (18.3 vs. 14.2 months in placebo arm), demonstrating a positive trend in the overall population, without reaching significance. Similarly to PFS, the effect was the greatest in patients with epithelioid histology, whose median overall survival was 20.6 months compared to 15.2 months with chemotherapy alone.

The safety profile of the experimental combination with nintedanib was as expected. Neutropenia (an abnormally low level of neutrophils, a type of white blood cell) was the most frequent grade ≥3 adverse event (nintedanib 43.2% vs. placebo 12.2%); rates of febrile neutropenia were low (2.3% vs. 0%). AEs leading to discontinuation were low, with fewer patients discontinuing treatment with nintedanib than in those patients in the placebo plus chemotherapy arm (3 patients vs. 7 patients; 6.8% vs. 17.1%). Typical adverse events observed with anti-angiogenesis compounds (e.g. hypertension, bleeding, thromboembolic event) were seen infrequently.

“The updated survival data from the LUME-Meso trial continue to demonstrate the positive effect of nintedanib in malignant pleural mesothelioma, particularly in patients with epithelioid type MPM,” said Mark A. Socinski, MD, Executive Medical Director, Florida Hospital Cancer Institute. “We look forward to confirming the efficacy and safety profile of nintedanib as a potential first-line, targeted therapy for MPM in the ongoing Phase III trial.”

Dr. Mehdi Shahidi, Corporate Vice President and Global Head of Oncology, Medicine at Boehringer Ingelheim commented, “We are pleased to see that the addition of nintedanib to standard first-line chemotherapy may translate into meaningful improvements in patients’ outcomes. MPM is a difficult-to-treat disease and these data are another encouraging step on our way to fulfilling the commitment of Boehringer Ingelheim to deliver novel therapeutic options to patients with malignant diseases.”

Nintedanib is currently being studied in the LUME-Meso Phase III trial [NCT01907100] and is recruiting at trial sites worldwide. Nintedanib targets the receptors of the VEGF, FGF, PGF and Src and Abl signaling, which are implicated in the development of malignant pleural mesothelioma.

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) 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 about 50,000 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 2016, Boehringer Ingelheim achieved net sales of about $17.6 billion (15.9 billion euros). R&D expenditure corresponds to 19.6 percent of its net sales.

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