Encouraging Phase II survival data for nintedanib in malignant pleural mesothelioma presented at ASCO 2017
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.
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.
For references and notes to editors, please visit: https://www.boehringer-ingelheim.com/press-release/mesothelioma-phase-ii
For more information, please visit: www.boehringer-ingelheim.com
Media + PR
Phone +49 (6132) 77-95614
Fax +49 6132 77 6601
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
FlipNpik Opens Its Private Sale to Public and Introduces Fiat-Based Payment Gateway19.7.2018 11:00 | Tiedote
In an unprecedented move, FlipNpik, the blockchain-powered social media platform for local businesses, democratises its private sale and allows everyone to enjoy the privileges and bonuses traditionally reserved only for the large investors. Known as 'whales', these powerful investors typically enjoy large bonuses during the private sale phase of ICOs (Initial Coin Offerings). FlipNpik now turns this practice on its head by eliminating the large investment required to benefit from the 'whale' bonus, which offers up to 100% bonus of FNP (FlipNpik) tokens to the public, leveling the playing field for small investors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180719005283/en/ Monetize your social media posts by supporting local shops (Graphic: Business Wire) Deploying one of the first fiat-based payment gateways using money transfers to facilitate ICO payments, FlipNpik also allows the larger community who may be new to bu
Pat Johnson Joins UniPrint Team in Europe19.7.2018 10:35 | Tiedote
UniPrint.net announced today that Pat Johnson has joined the company to support and develop their EMEA Partner Program, as well as with the promotion of their highly successful Cloud solutions UniPrint Infinity™ and ePRINTit™. Pat brings with him 20 years of experience at Xerox UK where he was instrumental in engaging with software vendors to support Xerox Connectkey products and Xerox Business Partner Channels. In joining UniPrint.net, Pat is well placed to support the continued growth of UniPrint.net EMEA Partners with the UniPrint product portfolio. Pat will hold the new position of MPS Partner & Strategy Manager EMEA, continuing UniPrint’s success in engaging valued business partners towards a modern approach for Software as a Service (SaaS) and Cloud printing solutions. Pat comments: “I am excited to start a new challenge within UniPrint.net and I look forward to working with the EMEA team to further develop their Partner Program. I am fortunate to be joining a respected company w
The Poseidon Foundation: Liverpool Bids to Be First ‘Climate Positive’ City by End of 202019.7.2018 10:34 | Tiedote
The Poseidon Foundation (“Poseidon”) have signed a ground-breaking partnership with Liverpool City Council in a bid to make Liverpool the world’s first climate positive city by the end of 2020. The city council has signed an agreement with Poseidon to integrate its ground-breaking blockchain-powered platform into Liverpool’s day to day operations. Poseidon’s technology offsets the carbon impact of any product or service by transparently supporting essential forest conservation projects, allowing individuals, organisations and governments to reverse the impact of climate change every day through their activities. Poseidon will be moving its operations to the city in order to play a key role in Liverpool’s new climate positive strategy, which will be trialled over the next 12 months. Poseidon, who are already working closely with Liverpool company BAC Mono to create the world’ first climate positive car, will work with local schools, universities and businesses to develop educational pro
Elliott Advisors (UK) Statement on thyssenkrupp AG19.7.2018 10:30 | Tiedote
Funds advised by Elliott Advisors (UK) Limited (“Elliott”) are significant shareholders in thyssenkrupp AG (“thyssenkrupp” or the “Company”). Elliott notes recent press coverage referencing the contents of a private letter Elliott sent to the thyssenkrupp Supervisory Board yesterday morning. In order to avoid any misunderstandings or misrepresentations of its substance, Elliott is hereby making the full text of the letter public. *** The Members of the Supervisory Board thyssenkrupp AG thyssenkrupp Allee 1 45143 Essen 18 July 2018 Ladies and Gentlemen, We note the resignation of Professor Dr. Ulrich Lehner as chairman of the Supervisory Board of thyssenkrupp AG. When we met with Professor Lehner in Essen on 27th June he and we assured each other of our desire to develop a constructive working relationship. Professor Lehner’s comments in the interview he gave to Die Zeit on 12th July suggest that he did not give those assurances in good faith. In the course of the interview with Die Zei
Albar Capital Deploys FlexNOW19.7.2018 10:30 | Tiedote
FlexTrade (@FlexTrade) today announced that Albar Capital Ltd., a new hedge fund led by Javier Velazquez (formerly of Millennium Capital Partners LLP), is now trading equities and futures using FlexNOW, FlexTrade’s new execution management system. “The FlexNOW team was instrumental in solving several of our problems,” said Jason Ruder, Trader at Albar Capital. “Not only are they helping us with our compliance requirements, they are also responsive to requests that improve my workflow.” According to Rhyd Lewis, FlexNOW Product Manager, FlexNOW’s quick onboarding and easy installation process was critical for Albar Capital’s launch on 2 July. “We had no problem integrating FlexNOW with Albar’s portfolio and risk management platform, Paladyne, which allows Fund Managers to route orders to the dealing desk,” said Lewis. “Additionally, Albar has connectivity to their executing venues via FlexTrade’s zero-touch broker network.” Multi-Asset, MiFID II Compliant Trading Designed to handle tradi
Entersekt Signs on to Mobile Connect19.7.2018 10:00 | Tiedote
Entersekt, an innovator in mobile-first fintech solutions, today announced it has signed an agreement with the GSMA to offer Mobile Connect to its institutional customers. Developed by the mobile industry as a universal mobile-device–based authentication service, Mobile Connect allows consumers across the globe to access their digital accounts via a single login. Users of the service do not have to remember multiple usernames and passwords. Instead, they identify themselves with their unique mobile number, together with a second factor like a PIN or biometric scan when additional security is required. Entersekt already offers advanced authentication and app security solutions, but the company believes Mobile Connect could help it address several increasingly urgent challenges banks face in streamlining customer-facing digital interactions. The service can facilitate the sharing with digital service providers of mobile-operator–held user and device data – and it is contextual informatio
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme