Boehringer Ingelheim has announced that its LUME-Colon 1 study has met one of the co-primary endpoints of progression-free survival (PFS) in pre-treated patients with metastatic colorectal cancer (mCRC).
The study investigated nintedanib plus best supportive care (BSC) versus BSC alone in mCRC patients who did not respond to other treatments.
Although nintedanib indicated clear anti-tumour activity and significantly reduced the risk of disease progression by 42% versus BSC, this did not show an overall survival (OS) benefit, the second co-primary endpoint.
The data indicated that the types of adverse events were consistent with those observed in previous nintedanib oncology trials, with no new or unexpected safety signals.
Belgium's University of Leuven professor of internal medicine and lead investigator professor Eric Van Cutsem said: "The data confirmed nintedanib is an active compound and had a significant effect in stabilising disease for patients with advanced colorectal cancer.
“Unfortunately, this benefit did not lead to an increase in overall survival and we are currently analysing the data to better understand this outcome."
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Boehringer Ingelheim vice president and global head of medicine for oncology Mehdi Shahidi said: "The ultimate goal of our oncology programmes 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 programme."
Nintedanib is being tested with 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 in December.
Patients are currently being recruited for Phase III of the study.