INGELHEIM, Germany & COPENHAGEN, Denmark–(BUSINESS WIRE)– Boehringer Ingelheim today announced the LUME-Colon 1 trial, investigating nintedanib* plus best supportive care (BSC) versus BSC alone, met one of the co-primary endpoints of progression-free survival (PFS) in pre-treated patients with metastatic colorectal cancer (mCRC), who no longer responded to, or tolerated, other available treatments. While nintedanib showed clear anti-tumour activity and significantly reduced the risk of disease progression by 42% versus BSC, this did not translate into an overall survival (OS) benefit, the second co-primary endpoint. The data showed that the adverse events were consistent with those observed in previous oncology trials, with no new or unexpected safety signals.
Lead investigator Professor Eric Van Cutsem, M.D., PhD, Professor of Internal Medicine at the University of Leuven in Belgium, commented, “The data confirmed nintedanib is an active compound that was well-tolerated 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.”
LUME-Colon 1 results will be presented today at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen, Denmark, 7–11 October (abstract #LBA20_PR – Proffered Paper, Gastrointestinal tumours, colorectal 1, Sunday 9 October, 14:45–16:15 CEST).
Mehdi Shahidi, M.D., Vice President and Global Head of Medicine, Oncology, Boehringer Ingelheim 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 in combination with docetaxel was approved in the EU in 2014 for use in adults with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy.
Nintedanib continues to be studied in 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 at the World Conference on Lung Cancer (WCLC) in December. The Phase III part of this global study is currently recruiting patients.
About LUME-Colon 1
LUME-Colon 1 [ NCT02149108] is a Phase III double-blind, randomised, placebo-controlled study designed to evaluate the efficacy and safety of nintedanib plus best supportive care (BSC), versus placebo plus BSC in pre-treated patients with metastatic colorectal cancer (mCRC) refractory to other available treatments. LUME-Colon 1 enrolled 768 patients with mCRC and was conducted at 150 sites worldwide, with locations in the U.S., Europe and Asia, amongst others. Patients received either oral nintedanib 200mg twice daily plus BSC, or matching placebo plus BSC. BSC is defined as the best palliative care per investigator decision. A statistically significant improvement in PFS was observed (HR=0.58, p<0.0001, median PFS: nintedanib 1.51 vs placebo 1.38 months) but no difference in OS (HR=1.01, p=0.8659, median OS: nintedanib 6.44 vs placebo 6.05 months). The most frequent ≥Grade 3 adverse events were liver related elevations (16% vs 8%) and fatigue (9% vs 6%).
* Nintedanib is approved in the EU under the brand name Vargatef ® for use in combination with docetaxel in adult patients with locally advanced, metastatic or locally recurrent NSCLC of adenocarcinoma tumour histology after first-line chemotherapy. Nintedanib is under regulatory review by health authorities in other countries outside the EU. Nintedanib is not approved in other oncology indications.
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