Phase III nintedanib trial results in patients with metastatic colorectal cancer announced at ESMO

Ridgefield, Conn., October 9, 2016 – Boehringer Ingelheim today announced the LUME-Colon 1 trial, investigating nintedanib plus best supportive care (BSC) versus BSC alone, met one of the co-primary endpoints of progression-free survival (PFS) in pre-treated patients with metastatic colorectal cancer (mCRC), who no longer responded to or tolerated other available treatments. While nintedanib showed clear anti-tumor activity and significantly reduced the risk of disease progression by 42% versus BSC, this did not translate into an overall survival (OS) benefit, the second co-primary endpoint. The data showed that the types of adverse events were consistent with those observed in previous nintedanib oncology trials, with no new or unexpected safety signals.

Lead investigator Professor Eric Van Cutsem, M.D., PhD, Professor of Internal Medicine at the University of Leuven in Belgium, commented, “The data confirmed nintedanib is an active compound and had a significant effect in stabilizing disease for patients with advanced colorectal cancer. Unfortunately, this benefit did not lead to an increase in overall survival and we are currently analyzing the data to better understand this outcome.”

LUME-Colon 1 results will be presented today at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen, Denmark, October 7–11 (abstract #LBA20_PR - Proffered Paper, Gastrointestinal tumors, colorectal 1, Sunday, October 9, 14:45–16:15 CEST (8:45–10:15 ET)).

Mehdi Shahidi, M.D., Vice President and Global Head of Medicine, Oncology, Boehringer Ingelheim said, “The ultimate goal of our oncology programs is to develop treatments that will change clinical practice to benefit the lives of patients and their families. While the outcome of the LUME-Colon 1 trial is not what we had hoped for, we continue to learn and evolve our research strategy with every study result from our development program.”

Nintedanib continues to be studied in other cancers, such as malignant pleural mesothelioma (MPM). Data from the Phase II LUME-Meso [NCT01907100] trial investigating nintedanib for patients with MPM will be presented at the World Conference on Lung Cancer (WCLC) in December. The Phase III part of this global study is currently recruiting patients.

About LUME-Colon 1
LUME-Colon 1 [NCT02149108] is a Phase III double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of nintedanib plus best supportive care (BSC), versus placebo plus BSC in pre-treated patients with metastatic colorectal cancer (mCRC) refractory to other available treatments. LUME-Colon 1 enrolled 768 patients with mCRC and was conducted at 150 sites worldwide, with locations in the U.S., Europe and Asia, amongst others. Patients received either oral nintedanib 200mg twice daily plus BSC, or matching placebo plus BSC. BSC is defined as the best palliative care per investigator decision. A statistically significant improvement in PFS was observed (HR=0.58, p<0.0001, median PFS: nintedanib 1.51 vs placebo 1.38 months) but no difference in OS (HR=1.01, p=0.8659, median OS: nintedanib 6.44 vs placebo 6.05 months). The most frequent ≥Grade 3 adverse events were liver related elevations (16% vs 8%) and fatigue (9% vs 6%).

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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