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Boehringer Ingelheim initiates pivotal programme for novel third-generation EGFR targeting lung cancer compound

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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.”

Intended audiences

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:

http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/03_november_2015_oncology.html

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www.facebook.com/boehringeringelheim

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*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.

Contact information

Boehringer Ingelheim
Corporate Communications
Media + PR
Reinhard Malin
Tel.: +49 (6132) 77-90815
Fax: +49 (6132) 77-6601
Email: press@boehringer-ingelheim.com

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