OREANDA-NEWS. December 23, 2015. Boehringer Ingelheim aims to achieve first market authorisation for BI 1482694 in patients with T790M-positive NSCLC in 2017.

  • In December 2015, the US FDA granted BI 1482694 with Breakthrough Therapy Designation
  • In October 2015, a New Drug Application for HM61713 / BI 1482694, was filed to the Korean Ministry of Food and Drug Safety.

About the HM-EMSI-101 study
This is a Phase I/II, multicenter study of BI 1482694 in Korean patients. All patients included in the trial had been previously treated with at least one EGFR TKI and may have received additional lines of chemotherapy or other systemic treatments. At the recommended Phase II dose (RP2D: 800mg qd), all eligible patients had to have confirmed T790M mutation in the tumour. The primary endpoint was OR; secondary endpoints included duration of response, disease control rate, progression-free survival (PFS) and safety.

About the ELUXA 1 (HM-EMSI-202) study
ELUXA 1 is an ongoing pivotal Phase II global clinical trial. It is designed to further investigate the efficacy and safety of BI 1482694 in patients with NSCLC whose tumours acquired T790M-mediated resistance after first-line EGFR TKIs. The ELUXA 1 trial is part of a broad ELUXA pivotal trial programme, which will include the initiation of Phase III studies in 2016.

*BI 1482694 is an investigational, novel, oral, 3rd-generation, EGFR mutant-specific tyrosine kinase inhibitor developed to target tumours with EGFR mutations including the resistance mutation T790M.

**Boehringer Ingelheim has an exclusive license and collaboration agreement with Hanmi Pharmaceutical Co. Ltd for the development and global commercialisation rights (except South Korea, China and Hong Kong) of BI 1482694 (HM61713).

Notes to Editors

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.

About BI 1482694 link to backgrounder

About Boehringer Ingelheim in Oncology
http://newscentre.boehringer-ingelheim.com/education_hub1/oncology/backgrounder/bi_oncology_backgrounder.html

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 146 affiliates and a total of more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative “Making more Health” and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 per cent of its net sales.

For more information please visit www.boehringer-ingelheim.com