On October 21, 2014 Boehringer Ingelheim reported the enrollment of the first patient in a new global Phase III study in patients with advanced colorectal cancer (CRC) (Press release Boehringer Ingelheim, OCT 20, 2014, View Source [SID:1234500853]). 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 enroll 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.