Boehringer Ingelheim launches ambitious ELUXA trial program to broadly investigate promising lung cancer compound olmutinib

The ELUXA trial program builds on the encouraging clinical data seen in the Phase I/II HM-EMSI-101 trial investigating olmutinib in EGFR mutation-positive lung cancer patients who have become resistant to first-line TKI therapy. The trial was the basis for the first registration of olmutinib in South Korea. An updated analysis of this trial will be presented at ASCO 2016.

Dr. Mehdi Shahidi, Medical Head, Solid Tumor Oncology, Boehringer Ingelheim commented, "With encouraging activity of olmutinib observed in patients with EGFR-mutation positive NSCLC, we are proudly announcing our extensive ELUXA trial program. We are excited to apply our expertise in this field, gained during the continuing development of afatinib through the LUX-Lung program, and launch another comprehensive clinical program. The ELUXA trial program is designed to shed further light on our understanding of EGFR mutation-positive lung cancer to ultimately improve the outcomes for patients with high unmet medical need."

Olmutinib will be investigated as monotherapy through the following trials:

• ELUXA 1: This Phase II trial was initiated in July 2015 and aims to help establish the safety and efficacy of olmutinib in patients with EGFR T790M mutation-positive lung cancer, following initial EGFR TKI treatment. The study has completed enrollment with more than 150 patients worldwide and will form the basis of regulatory submissions
• ELUXA 2: This Phase III trial will be initiated in 2016 to investigate the efficacy and safety of olmutinib in comparison to standard, platinum-doublet chemotherapy for patients with EGFR T790M mutation-positive lung cancer, whose disease progressed on one prior EGFR-TKI treatment
• ELUXA 3: This Phase III head-to-head trial to be initiated in 2016 will investigate olmutinib as a first-line treatment compared to a second-generation EGFR TKI, afatinib (Gilotrif®), in patients with EGFR mutation-positive NSCLC
• ELUXA 4: This Phase I/II trial in Japanese patients with EGFR T790M mutation-positive NSCLC will be initiated in 2016
• ELUXA 6: This Phase II study will be the first trial to prospectively use blood-based biomarker testing to select patients with EGFR T790M mutation-positive NSCLC where a needle biopsy may not be appropriate

As the landscape of lung cancer care changes, and the development of novel therapies and biomarker testing continue to rapidly evolve, Boehringer Ingelheim is committed to investigating how treatment approaches might be combined to develop more effective therapies and sequences of treatments for patients. By targeting multiple oncogenic mechanisms, research suggests that combinations may overcome drug resistance and better control cancer, delivering improved outcomes for patients.

The ELUXA trial program will investigate olmutinib in different settings of EGFR mutation-positive lung cancer in combination with both Boehringer Ingelheim compounds and treatments developed by external parties. These trials will include:

• Olmutinib in combination with pembrolizumab (Keytruda®), a new collaboration through a subsidiary of Merck
• Olmutinib plus afatinib (Gilotrif®)
• Olmutinib plus IGF ligand-neutralizing antibody BI 836845
• Olmutinib plus oral nintedanib
• Olmutinib plus bevacizumab (Avastin®)

About olmutinib (BI 1482694)
Olmutinib (BI 1482694) is a third-generation EGFR mutant-specific TKI. It is currently being investigated for the treatment of patients with advanced and metastatic EGFR mutation-positive NSCLC, whose tumors acquired T790M-mediated resistance to initial EGFR TKI treatment. The compound will be further investigated in the ELUXA Clinical Trial Program which includes initiation of Phase III studies in 2016 as well as Phase I and II studies in the first- and second-line setting. Olmutinib (BI 1482694) showed promising clinical activity, combined with a favorable safety profile in a Phase I/II clinical trial (HM-EMSI-101). This trial was the basis for Breakthrough Therapy Designation granted by U.S. FDA in 2015 and the first approval for the treatment of patients with T790M mutation-positive lung cancer in South Korea in 2016.

Boehringer Ingelheim
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.

Boehringer Ingelheim is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 145 affiliates and more than 47,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.

Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families.  Our employees create and engage in programs that strengthen our communities. To learn more about how we make more health for more people, visit our Corporate Social Responsibility Report.

In 2015, Boehringer Ingelheim achieved net sales of about $15.8 billion (14.8 billion euros). R&D expenditure corresponds to 20.3 percent of its net sales.

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Keytruda® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Avastin® is a registered trademark of Genentech, Inc. (USA)

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