INGELHEIM, Germany I October 21, 2014 I Boehringer Ingelheim today announced the enrolment of the first patient in a new global Phase III study in patients with advanced colorectal cancer (CRC). Colorectal cancer is the third most common cancer in the world, with nearly 1.4 million new cases diagnosed each year. Prognosis is poor for patients with advanced CRC with fewer than 10% surviving for more than five years after diagnosis.
LUME-COLON 1 [ClinicalTrials.gov identifier: NCT02149108] is a double-blind, randomised, placebo-controlled study designed to evaluate the efficacy and safety of nintedanib* plus best supportive care (BSC), versus placebo plus BSC, after previous treatment with standard chemotherapy and biological agents. This new study builds on the early efficacy signs observed with nintedanib* in CRC during Phase I/II trials.
“There is a significant need to improve treatment options for patients with advanced colorectal cancer and Boehringer Ingelheim is proud to conduct further research into this disease area. The initiation of LUME-COLON 1 reinforces our ongoing commitment to driving innovation in oncology research,” said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim.
LUME-COLON 1 plans to enrol more than 750 patients with CRC, whose disease has progressed on previous treatment and will be conducted at 150 sites worldwide, with locations in the U.S., Europe and Asia, amongst others. Patients will receive either nintedanib* 200mg twice daily plus BSC, or matching placebo plus BSC. BSC is defined as the best palliative care per investigator decision. The co-primary endpoints will be progression-free survival (PFS), evaluated by blinded review and overall survival (OS). Secondary endpoints are objective tumour response rate and disease control rate.
In the EU, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the approval of nintedanib* in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent NSCLC of adenocarcinoma tumour histology after first line chemotherapy.
Another EU marketing authorisation application (MAA), has been submitted for nintedanib* in the treatment of idiopathic pulmonary fibrosis (IPF). In the U.S., the Food and Drug Administration (FDA) has approved nintedanib* capsules under the brand name OFEV™ for oral use for the treatment of IPF.
About nintedanib*
Nintedanib* is an oral triple angiokinase inhibitor which simultaneously inhibits vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptors (PDGFR) and fibroblast growth factor receptor (FGFR) signalling pathways, the three receptors crucially involved in angiogenesis and tumour growth.6 Growing scientific evidence shows that these three different angiokinase receptors play an important role not only in angiogenesis but also in tumour growth and metastasis.7,8
Nintedanib* is currently being investigated in patients with various solid tumours including Phase III studies in advanced NSCLC2, colon cancer (colorectal cancer refractory to standard treatment)9 and ovarian cancer10, and also in Phase II studies in mesothelioma11, kidney cancer (renal cell carcinoma)12 and liver cancer (hepatic cell carcinoma)13.
About Colorectal Cancer
Colorectal cancer is a cancer in the colon or rectum (parts of the large intestine). Like other cancers, colorectal cancer starts in a small area but can spread to other parts of the body to form metastatic tumours.14 Symptoms of colorectal cancer typically include rectal bleeding and anaemia which are sometimes associated with weight loss and changes in bowel habits.15 Some colorectal cancers occur due to lifestyle, increasing age or underlying genetic causes.16 Colorectal cancer is the third most common cancer in the world, with nearly 1.4 million new cases diagnosed each year. It is predicted that this number will increase to 2.4 million cases each year by 2035.17
About Boehringer Ingelheim in Oncology
http://www.newshome.com/education_hub1/oncology.html
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 142 affiliates and a total of more than 47,400 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.
Taking social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative “Making more Health” and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.
In 2013, Boehringer Ingelheim achieved net sales of about 14.1 billion euros. R&D expenditure corresponds to 19.5% of its net sales.
*Nintedanib in oncology is an investigational compound and is not yet approved; its safety and efficacy have not yet been fully established.
References
1 Clinical Trial: A double-blind randomised, placebo-controlled, Phase III study of nintedanib plus best supporting care (BSC) versus placebo plus BSC, in patients with colorectal cancer refractory to standard therapies: https://clinicaltrials.gov/ct2/show/NCT02149108?term=nintedanib+AND+Colon&rank=2
2 Reck et al. Docetaxel plus nintedanib versus docetaxel plus placebo in patients with previously treated non-small-cell lung cancer (LUME-Lung 1): a phase 3, double-blind, randomised controlled trial. Lancet Oncol 2014;15:143–55.
3 Van Cutsem E, et al. Improving outcomes in colorectal cancer: Where do we go from here? Eur J Cancer. 2013 Jul;49(11):2476-85.
4 Van Cutsem E., et al,. A Phase l/lI, Open-label, Randomised Study of BIBF 1120 Plus mFOLFOX6 Compared to Bevacizumab Plus mFOLFOX6 in Patients with Metastatic Colorectal Cancer. Eur J Cancer 2011; 47; 2: 8–9.
5 Mross et al. Vascular effects, efficacy and safety of nintedanib in patients with advanced, refractory colorectal cancer: a prospective phase I subanalysis BMC Cancer 2014, 14:510
6 Hilberg F, et al. BIBF1120: triple angiokinase inhibitor with sustained receptor blockade and good anti-tumor efficacy. Cancer Res 2008;68:4774-82.
7 Folkman J. Clinical Applications of Research on Angiogenesis. N Engl J Med 1995;333:1757–1763.
8 Bousquet C, et al. Suppression of angiogenesis, tumor growth, and metastasis by adenovirus-mediated gene transfer of human angiotensinogen. Mol Ther 2006;14:175-82.
9 Nintedanib (BIBF 1120) vs Placebo in Refractory Colorectal. Cancerhttps://clinicaltrials.gov/ct2/show/NCT02149108?term=nintedanib+colorectal&rank=2
10 AGO-OVAR 12/LUME-Ovar. Presented at ESGO 2013 Du Bois A et al.
11 Nintedanib (BIBF 1120) in Mesothelioma. Available at http://clinicaltrials.gov/ct2/show/NCT01907100?term=nintedanib+mesothelioma&rank=1
12 Compare Safety and Efficacy of BIBF 1120 Versus Sunitinib. Available at http://clinicaltrials.gov/ct2/show/NCT01024920?term=nintedanib+renal&rank=1
13 Phase I/II Comparison of Efficacy and Safety of BIBF 1120 and Sorafenib in Patients With Advanced Hepatocellular Carcinoma. Available at: clinicaltrials.gov/ct2/show/NCT01004003?term=nintedanib+hepatic+cancer&rank=2
14 EuropaColon, Colorectal Cancer. Available at: http://www.europacolon.com/colorectalcancer.php?Action=Colorectalcancer (Last accessed September 2014)
15 American Cancer Society, Colorectal Cancer. Available at
http://www.cancer.org/cancer/colonandrectumcancer/detailedguide/colorectal-cancer-signs-and-symptoms (Last accessed September 2014)
16 American Cancer Society, Colorectal Cancer. Available at http://www.cancer.org/cancer/colonandrectumcancer/detailedguide/colorectal-cancer-risk-factors (Last accessed September 2014)
17 GLOBOCAN 2012. Available at: http://globocan.iarc.fr/old/burden.asp?selection_pop=224900&Text-p=World&selection_cancer=5060&Text-c=Colorectum&pYear=23&type=0&window=1&submit=%C2%A0Execute (Last accessed September 2014)
SOURCE: Boehringer Ingelheim
