INGELHEIM, Germany--(BUSINESS WIRE)--Boehringer Ingelheim today announced that Phase II results from LUME-Meso, a randomised, double-blind, placebo-controlled trial, have been presented as part of an Oral Abstract Session at the 2017 Annual Meeting of the American Society of Clinical Oncology (ASCO). Nintedanib*, an oral triple angiokinase inhibitor, demonstrated improved progression-free survival (PFS, primary endpoint) and overall survival (OS, secondary endpoint) when added to standard first-line chemotherapy of pemetrexed/cisplatin in patients with malignant pleural mesothelioma (MPM) compared to chemotherapy alone. In this study, treatment with nintedanib or placebo continued after chemotherapy until progression or toxicity.
MPM is a rare thoracic cancer, representing less than 1% of all cancers and is often related to long-term asbestos exposure. MPM patients have a poor prognosis, with less than 10% surviving for five years following diagnosis. MPM is broadly categorised by cell type, or histology, in three subtypes (epithelioid, biphasic and sarcomatoid) with epithelioid being the most common, accounting for 50%-70% of all diagnoses.
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 an encouraging 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 (an abnormally low level of neutrophils, a type of white blood cell) 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%). Typical AEs observed with anti-angiogenesis compounds (e.g. hypertension, bleeding, thromboembolic event) were seen infrequently.
Dr. Mehdi Shahidi, Corporate Vice President and Global Head of Oncology, Medicine at Boehringer Ingelheim commented, “We are pleased to see that the addition of nintedanib to standard first-line chemotherapy may translate into meaningful improvements in patients’ outcomes. MPM is a difficult-to-treat disease and these data are another encouraging step on our way to fulfilling the commitment of Boehringer Ingelheim to deliver novel therapeutic options to patients with malignant diseases.”
Nintedanib is currently being studied in the LUME-Meso Phase III trial [NCT01907100] and is recruiting at trial sites worldwide. Nintedanib targets the receptors of the VEGF, FGF, PGF and Src and Abl signaling, which are implicated in the development of malignant pleural mesothelioma.
*Nintedanib is approved in the EU and more than 20 other countries worldwide under the brand name VARGATEF® for use in combination with docetaxel in adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer of adenocarcinoma tumour histology after first-line chemotherapy. Nintedanib is not approved in other oncology indications.
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