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
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
AstraZeneca and Chi-Med’s Savolitinib Shows Encouraging Clinical Activity in 2nd-Line EGFR Mutation-positive Lung Cancer with MET-amplification16.10.2017 22:00 | Pressemelding
AstraZeneca and its partner Chi-Med today presented preliminary safety and clinical activity of savolitinib when given in combination with either Tagrisso (osimertinib) or Iressa (gefitinib) in two Phase Ib trials conducted in patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) with MET-amplification who had progressed following 1st-line treatment with an EGFR inhibitor.1,2 In both trials, the addition of savolitinib (600mg, once daily), an investigational selective inhibitor of c-MET (mesenchymal epithelial transition factor) receptor tyrosine kinase, to osimertinib (80mg, once daily) or gefitinib (250mg, once daily) demonstrated preliminary anti-tumour activity. The data were shared in two oral presentations at the International Association for the Study of Lung Cancer 18th World Conference on Lung Cancer (WCLC) in Yokohama, Japan, 15-18 Oc
Orlando Melbourne Int’l (MLB) Lands Largest FAA Grant in Its History16.10.2017 21:34 | Pressemelding
When Air Force One landed at Orlando Melbourne International Airport (MLB) in February, Airport Executive Director Greg Donovan took advantage of the opportunity and advised the president of the United States that his 747-200 just landed on a commercial runway officially rated ‘poor’ in aviation terms. That’s going to change, thanks to an $18,132,588 FAA grant announced by U.S. Secretary of Transportation Elaine Chao today. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171016006292/en/ Greg Donovan, A.A.E. (Photo: Business Wire) “We asked for, and received, tremendous support from the Florida congressional delegation,” said Jack L. Ryals, chairman of the Melbourne Airport Authority. “We are deeply grateful to Congressman Posey, Senator Nelson and Senator Rubio for their advocacy on this critic
Colombia Selects IDEMIA to Upgrade Its Identification and Civil Registry Platform16.10.2017 14:34 | Pressemelding
IDEMIA, the global leader in trusted identities for an increasingly digital world, has been selected by the National Civil Registry of Colombia (Registraduría Nacional del Estado Civil de Colombia – RNEC 1 ) to update the identification and civil registry platform. This platform is the trusted repository of citizens’ biometric and alphanumeric data and ensures the uniqueness of identities. IDEMIA (formerly known as OT-Morpho) has worked with the RNEC since the beginning of this project and has constantly supported the successive improvements of the solution. In 2017, when in need to strengthen the platform in order to offer new services to the government and to the population while maintaining a high level of security and satisfaction of the users, RNEC decided to pursue its partnership with IDEMIA. Through this new contract, IDEMIA will e
ATB Financial Goes-Live on Murex’s SaaS Solution16.10.2017 14:00 | Pressemelding
Sibos - Murex, a global leader in trading, risk management and processing solutions, is pleased to announce the successful launch of the MX.3 SaaS solution at ATB Financial. MUREX SaaS is a managed services offering for the MX.3 platform, encompassing infrastructure and application management. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171016005092/en/ ATB pursued this initiative in order to create a simple yet comprehensive foreign exchange experience for their customers. In addition to the customer benefit, ATB was also able to rationalize their IT landscape, broaden the scope of financial instruments they provide on their digital platform, and prepare for a large volume increase in their trading activities. Due to the strength of the solution’s risk management capabilities, extensive asset class coverage, and the ra
Leave a review on print24.com and win a VW up!16.10.2017 13:59 | Pressemelding
The online print shop UNITEDPRINT SE, owner of renowned brands including print24.com, is asking its customers for their opinions on the company’s products and services. In return for their views, customers will receive vouchers and be entered into a prize draw. The online print shop is offering one voucher for every review submitted across various portals. The vouchers – worth up to €25.00 and valid until 31 March 2018 – will be subject to a minimum order amount (product price inc. VAT, not including delivery) of €250.00 per voucher. All reviews received up to 31 December 2017 will be eligible, regardless of length and content. You can learn more about the review campaign at https://print24.com/rate/ But not only that, print24.com is also giving every reviewer the chance to win a brand-new VW up! Ali Jason Bazooband, Managing Director for Innovation/Marketing at print24.com,
Bentley Systems Announces Winners of 2017 Be Inspired Awards16.10.2017 13:52 | Pressemelding
The Year in Infrastructure 2017 Conference – Bentley Systems, Incorporated, a leading global provider of comprehensive software solutions for advancing infrastructure, has announced the winners of the 2017 Be Inspired Awards. The annual awards program honors the extraordinary work of Bentley users advancing the world’s infrastructure. At a ceremony and gala at their Year in Infrastructure 2017 Conference, Bentley acknowledged 17 Be Inspired Awards winners and six Special Recognition Awards winners. The Year in Infrastructure Conference is Bentley’s annual global gathering of leading professionals in the world of infrastructure design, construction, and operations. In addition to thought-provoking keynotes, technology demonstrations, industry forums, and panel discussions, the agenda included presentations by finalists in the Be Inspired Awards program, culminating in the selection of t
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom