Boehringer Ingelheim initiates pivotal programme for novel third-generation EGFR targeting lung cancer compound
Boehringer Ingelheim today announced at the BIO-Europe® conference in Munich, Germany, the initiation of a global Phase II trial evaluating the efficacy and safety of BI 1482694 (HM61713) in patients with T790M mutation-positive non-small cell lung cancer (NSCLC), whose tumours stopped responding to currently available epidermal growth factor receptor (EGFR) directed therapies. The primary endpoint of this trial, which is the first in a broad clinical development programme for BI 1482694, is objective response rate (ORR).
Coordinating investigator Professor Keunchil Park, Division of Hematology & Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, South Korea commented, “Third-generation EGFR TKIs, which were developed to overcome the most frequent resistance mechanism to available first- and second-generation compounds, could become an important addition to our armamentarium against EGFR-mutant lung cancer. In this patient population with T790M we are now able to investigate a follow-on targeted therapy and potentially further delay the use of burdensome chemotherapy regimens.”
BI 1482694 is a novel, third-generation, oral, irreversible EGFR mutant-specific tyrosine kinase inhibitor (TKI) developed to specifically target tumours with T790M mutations. At this year’s American Society of Clinical Oncology (ASCO) Annual Meeting, interim results of the Phase I/II clinical trial indicated strong efficacy signals in patients with such tumours, combined with a favourable safety profile.1 The T790M mutation is known as the most common resistance mechanism to develop in response to treatment with EGFR TKIs. It is found in approximately 50-60% of patients who previously received EGFR TKI therapy. There are currently no EGFR-directed therapies approved specifically for the treatment of this mutation, representing an area of great unmet need for these patients.
Boehringer Ingelheim has a strong presence in the field of EGFR mutated lung cancer with the approved GIOTRIF®/GILOTRIF® (afatinib*). Results from two large trials (LUX-Lung 3 and LUX-Lung 6) independently showed a significant improvement in the secondary endpoint of overall survival for the subgroup of patients with the most common EGFR mutation (del19) for this EGFR directed agent compared to chemotherapy. The most common adverse events were associated with mechanistic effects of EGFR inhibition and were generally predictable, manageable and reversible.2 VARGATEF® (nintedanib**), a triple angiokinase inhibitor is approved 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. Further lung cancer compounds from Boehringer Ingelheim’s pipeline are in different stages of development and, together with BI 1482694, Boehringer Ingelheim remains committed to continuing to advance lung cancer therapy. The aim is to achieve first market authorisation for BI 1482694, in this patient population, by 2017.
Dr Mehdi Shahidi, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim commented, “We are investing strongly in our lung cancer pipeline, and together with the oncology community we aim to develop better treatment options for these patients. The addition of BI 1482694 to Boehringer Ingelheim’s lung cancer portfolio further underscores our commitment to patients with cancer. The initiation of the first pivotal trial of BI 1482694 is an important milestone in the forthcoming broad clinical trial programme, including several Phase III trials.”
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:
Further Media Channels
*Afatinib is approved in a number of markets, including the EU, Japan, Taiwan and Canada under the brand name GIOTRIF ® and in the U.S. under the brand name GILOTRIF ® for use in patients with distinct types of EGFR mutation-positive NSCLC. Registration conditions differ internationally, please refer to locally approved prescribing information. Afatinib is under regulatory review by health authorities in other countries worldwide. Afatinib is not approved in other indications.
**Nintedanib is not approved in other oncology indications. 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.
Media + PR
Tel.: +49 (6132) 77-90815
Fax: +49 (6132) 77-6601
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Cushman & Wakefield To Acquire Its Irish Affiliate From Sherry FitzGerald Group16.7.2018 13:49 | Pressemelding
Global real estate services firm Cushman & Wakefield today announces it has entered into a definitive agreement to acquire the commercial property arm of Sherry FitzGerald Group in the Republic of Ireland. The deal is expected to complete in early September 2018. Cushman & Wakefield already has a 20% stake in the Irish commercial property business which operated as its exclusive affiliate in the Republic – rebranding two years ago as Cushman & Wakefield Ireland. The firm, which has more than 100 commercial property professionals and offices in Dublin, Limerick and Galway, will now be fully integrated into Cushman & Wakefield, one of the world’s largest real estate services firms with 48,000 employees in approximately 400 offices and 70 countries. Managing Director Aidan Gavin becomes Cushman & Wakefield’s Head of Ireland and will also sit on the firm’s UK & Ireland Executive Committee. Cushman & Wakefield will maintain its close affiliate relationship with the wider Sherry FitzGerald G
Fischer & Schickendantz and Solution Alliance SRL Adopt Andersen Brand in Uruguay16.7.2018 13:30 | Pressemelding
Fischer & Schickendantz, led by Juan Federico Fischer, and Solution Alliance SRL, led by Juan Ignacio Troccoli, have rebranded this week as Andersen Tax & Legal, a member firm of Andersen Global. The firm, based in Montevideo, entered a Collaboration Agreement with Andersen Global in September 2017, and is now a fully integrated member of the global verein. Juan Federico Fischer remarked, “Andersen is a symbol of quality and is recognized worldwide by both clients and professionals, and is ahead of the game in terms of creating a global firm with integrated tax and legal services. We are truly excited to officially be part of the team.” “Throughout their time with us as a collaborating firm and now a member firm, the team in Uruguay has demonstrated a deep commitment to providing seamless, best-in-class service. Additionally, Juan Federico is a member of Andersen Global’s Latin American regional board, and is the true embodiment of the values that our organization represents. I look fo
Norsk Titanium Produces Space Demonstration Hardware16.7.2018 11:00 | Pressemelding
Norsk Titanium (Norsk), the world’s first FAA-approved supplier of aerospace-grade, additive manufactured, structural titanium components, has produced an Expansion Nozzle demonstrator in support of the European Space Agency’s Technology Research Programme (TRP). The TRP is an European Space Agency (ESA) technology development effort supporting all of ESA’s fields of activity across the entire spectrum of technical disciplines, providing the technological nucleus for most future developments. Norsk was awarded a TRP contract with the ESA in 2014 to explore the application of Norsk’s Rapid Plasma Deposition™ (RPD™) process to space applications. Through the TRP contract, Norsk has refined its material characterization and quality assurance processes, while providing ESA valuable insight into the application of additive processes to their unique needs. The culmination of this effort was the production of an Expansion Nozzle demonstrator. The Expansion Nozzle utilizes the latest RPD™ desi
CALVIN KLEIN Fragrances Announces Lupita Nyong'o and Saoirse Ronan as Faces of CALVIN KLEIN WOMEN16.7.2018 11:00 | Pressemelding
Calvin Klein, Inc., a wholly owned subsidiary of PVH Corp. [NYSE:PVH], and Calvin Klein Fragrances, a division of Coty Inc. [NYSE:COTY], today revealed the worldwide print advertising campaign for the new fragrance CALVIN KLEIN WOMEN , the first CALVIN KLEIN fragrance to be developed under the vision of Chief Creative Officer, Raf Simons. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180716005092/en/ CALVIN KLEIN WOMEN The campaign features Lupita Nyong'o and Saoirse Ronan. Award-winning actors and voices of their generation, both women are universally recognized for their unique talent, creativity, intelligence and strength of character. Directed by artist Anne Collier with creative direction from Lloyd & Co., the campaign champions iconic women and celebrates heroines of contemporary culture. Lupita and Saoirse are featured in the print campaign, in a pair of striking and direct portraits, positioned next to chosen figure
Bank of America Reports Second-Quarter 2018 Financial Results16.7.2018 10:45 | Pressemelding
Bank of America reported its second-quarter 2018 financial results today. The news release, supplemental filing and investor presentation can be accessed in the following ways: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180716005280/en/ Bank of America newsroom at https://newsroom.bankofamerica.com Bank of America Investor Relations website at http://investor.bankofamerica.com Business Wire’s news webpage at http://www.businesswire.com/portal/site/home/news Investor Conference Call information Chief Executive Officer Brian Moynihan and Chief Financial Officer Paul Donofrio will discuss the financial results in a conference call at 8:30 a.m. ET today. For a listen-only connection to the conference call, dial 1.877.200.4456 (U.S.) or 1.785.424.1732 (international), and the conference ID is 79795. Please dial in 10 minutes prior to the start of the call. Investors can also listen to a live audio webcast of the conference ca
Bank of Singapore is the First Singapore Private Bank to Receive Regulatory Approval to Open a Wealth Management Subsidiary in Luxembourg16.7.2018 09:36 | Pressemelding
Bank of Singapore today announced that it has been granted an investment company licence to operate a wealth management subsidiary in Luxembourg – a first for a Singapore private bank. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180716005252/en/ (Photo: BOSWM) Bank of Singapore, through this new subsidiary, BOS Wealth Management Europe Société Anonyme (S.A.), will be able to offer a comprehensive range of customised private banking solutions and investment advisory services to its ultra-high and high net worth clients in the European Economic Area (“EEA”) and the United Kingdom (“UK”). The EEA comprises the European Union (EU) countries and Iceland, Liechtenstein and Norway. Currently, Bank of Singapore serves its European clients from its Singapore headquarters and through its parent company OCBC Bank’s London office. There has been robust growth in assets under management from EEA clients as they hold Singapore in high