Boehringer Ingelheim announced the enrollment 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 per cent 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 US., 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 US, the Food and Drug Administration (FDA) has approved nintedanib capsules under the brand name OFEV for oral use for the treatment of IPF.

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. 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.

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) and ovarian cancer, and also in phase II studies in mesothelioma, kidney cancer (renal cell carcinoma) and liver cancer (hepatic cell carcinoma).

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. Symptoms of colorectal cancer typically include rectal bleeding and anaemia which are sometimes associated with weight loss and changes in bowel habits. Some colorectal cancers occur due to lifestyle, increasing age or underlying genetic causes. 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.

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.

Nintedanib in oncology is an investigational compound and is not yet approved; its safety and efficacy have not yet been fully established.