Boehringer Ingelheim has started patient enrolment in a new global Phase III trial (LUME-COLON 1) of nintedanib to treat advanced colorectal cancer (CRC).
The double-blind, randomised, placebo-controlled LUME-COLON 1 trial will 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.
The new trial builds on the early efficacy signs observed with nintedanib in CRC during Phase I/II trials.
Boehringer Ingelheim chief medical officer Dr Klaus Dugi said: "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."
The trial will enrol around 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.
During the trial, patients will be given either nintedanib 200mg twice daily plus BSC, or matching placebo plus BSC.
The co-primary endpoints of the trial will be progression-free survival (PFS), evaluated by blinded review and overall survival (OS), while secondary endpoints are objective tumour response rate and disease control rate.
In the European Union (EU), the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the approval of nintedanib in combination with docetaxel to treat adult patients with locally advanced, metastatic or locally recurrent NSCLC of adenocarcinoma tumour histology after first line chemotherapy.
The company has also submitted another EU marketing authorisation application (MAA) for nintedanib in the treatment of idiopathic pulmonary fibrosis (IPF).
The US Food and Drug Administration (FDA) has approved nintedanib capsules under the brand name OFEV for oral use to treat IPF.