Date: 2017-06-05
Type of
information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the American Society of Clinical Oncology (ASCO) annual meeting, in Chicago
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: mesothelioma
Therapeutic
area: Cancer - Oncology - Rare diseases
Country: Argentina, Australia, Austria, Belgium, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, France, Germany, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russian Federation, South Africa, Spain, Sweden, Turkey, UK, USA
Trial
details:
- LUME-Meso is a phase II/III confirmatory study designed to evaluate the safety and efficacy of nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib (BIBF 1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of patients with unresectable malignant pleural mesothelioma. (NCT01907100)
Latest
news:
- • On June 5, 2017, Boehringer Ingelheim announced that Phase II results from LUME-Meso have been presented at the 2017 Annual Meeting of the American Society of Clinical Oncology (ASCO). Nintedanib demonstrated improved progression-free survival and overall survival when added to standard first-line chemotherapy of pemetrexed/cisplatin in patients with malignant pleural mesothelioma compared to chemotherapy alone. In this study, treatment with nintedanib or placebo continued after chemotherapy until progression or toxicity.
- The updated Phase II PFS results from the LUME-Meso study showed oral, twice-daily nintedanib, when added to standard chemotherapy, nearly halved the risk of disease progression. A 46% reduction was demonstrated, with a significant improvement in median PFS of 3.7 months (9.4 nintedanib vs 5.7 placebo) in the overall study population (patients with either an epithelioid or biphasic cell type) compared to placebo plus standard chemotherapy alone. In patients with an epithelioid cell type, nintedanib plus chemotherapy demonstrated a greater median PFS benefit of 4 months (9.7 nintedanib vs 5.7 placebo).
- The primary OS analysis showed a 4.1 month improvement in the median OS for patients receiving nintedanib in addition to chemotherapy (18.3 nintedanib vs 14.2 placebo), demonstrating a positive trend in the overall population, without reaching significance. Similarly to PFS, the effect was the greatest in patients with epithelioid histology, whose median overall survival was 20.6 months compared to 15.2 months with chemotherapy alone.
- The safety profile of the experimental combination with nintedanib was as expected. Neutropenia was the most frequent grade ?3 adverse event (nintedanib 43.2% vs placebo 12.2%); rates of febrile neutropenia were low (2.3% vs 0%). AEs leading to discontinuation were low, with fewer patients discontinuing treatment with nintedanib than in those patients in the placebo plus chemotherapy arm (3 patients vs. 7 patients; 6.8% vs 17.1%).1 Typical AEs observed with anti-angiogenesis compounds (e.g. hypertension, bleeding, thromboembolic event) were seen infrequently.1
- • On May 9, 2016, Boehringer Ingelheim announced the enrolment of the first patient in the global Phase III trial evaluating the efficacy and safety of nintedanib in combination with pemetrexed/cisplatin, followed by continuing nintedanib monotherapy, as a first-line treatment for patients with unresectable malignant pleural mesothelioma (MPM). Patients will qualify for enrolment in the trial if they are not eligible to undergo surgical resection, have received no prior first-line therapies for MPM and hold an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. LUME-Meso will randomise 397 patients in a double-blind, multi-centre, global comparison of nintedanib in combination with pemetrexed/cisplatin or matching placebo in combination with pemetrexed/cisplatin as a first-line treatment.1 For patients whose disease has not progressed after a maximum of six cycles of chemotherapy, nintedanib or matching placebo will continue to be administered orally as a monotherapy on a daily basis, until disease progression or unmanageable side effects. The primary endpoint of the trial is progression-free survival and overall survival is the key secondary endpoint. Other secondary endpoints include objective tumour response and disease control.
Is
general: Yes
