Boehringer Ingelheim has initiated the ELUXA trial program, designed to further investigate the therapeutic potential of olmutinib (BI 1482694), a novel third-generation, epidermal growth factor receptor (EGFR) mutation-specific tyrosine kinase inhibitor (TKI) for the treatment of EGFR mutation-positive non-small cell lung cancer (NSCLC). The company will comprehensively investigate olmutinib as a monotherapy in different settings as well as in combination with investigational and established anti-cancer treatments, such as Merck's anti-PD-1 therapy, pembrolizumab (Keytruda®). Third-generation EGFR TKIs, including olmutinib, aim to provide new, much-needed treatment options for patients who have developed resistance to first- and second-generation TKIs and their potential as new treatment options in first-line is currently being investigated.
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®)