Date: 2016-10-09
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the European Society for Medical Oncology (ESMO) 2016 Congress
Company: Boehringer Ingelheim (Germany)
Product: nintedanib
Action
mechanism: tyrosine kinase inhibitor. Nintedanib targets three growth factors: the vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR) and platelet-derived growth factor receptor (PDGFR). These receptors have been shown to be potentially involved in pathomechanisms of pulmonary fibrosis. By blocking these signaling pathways that are involved in fibrotic processes, it is hypothesized that there may be potential to reduce disease progression, and thereby slow the decline of lung function. 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.
Disease: advanced colorectal cancer
Therapeutic area: Cancer - Oncology
Country: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Germany, Hong Kong, Italy, Republic of Korea, Luxembourg, The Netherlands, Portugal, Spain, Sweden, Taiwan, Turkey, UK, USA
Trial
details: LUME-Colon 1 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. 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%). (NCT02149108)
Latest
news: * On October 9, 2016, Boehringer Ingelheim 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. LUME-Colon 1 results have been presented at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen, Denmark, 7–11 October (abstract #LBA20_PR). 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. * On October 21, 2014, Boehringer Ingelheim announced the enrolment of the first patient in a new global Phase III study in patients with advanced colorectal cancer. This new study builds on the early efficacy signs observed with nintedanib* in CRC during Phase I/II trials. 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 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.
