INGELHEIM, Germany - Thursday, June 2nd 2016 [ME NewsWire]
Comprehensive ELUXA trial programme explores olmutinib* (BI 1482694) as a monotherapy and in several combination studies
Olmutinib will be studied in combination with the immuno-oncology therapy Keytruda®+, second-generation TKI Giotrif®/Gilotrif®**, anti-angiogenic agents Vargatef®*** and Avastin®, and Boehringer Ingelheim’s investigational IGF mAb BI 836845****
Accelerated trial programme underway with ELUXA 1 trial fully enrolled; additional Phase III trials to start soon
(BUSINESS WIRE)-- Boehringer Ingelheim has initiated the ELUXA trial programme, designed to further investigate the therapeutic potential of olmutinib* (BI 1482694 / HM61713), 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 MSD’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 programme 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 Tumour 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 programme. We are excited to apply our expertise in this field, gained during the continuing development of afatinib through the LUX-Lung programme, and launch another comprehensive clinical programme. The ELUXA trial programme 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 a monotherapy through the following trials:
ELUXA 1 (HM-EMSI-202): This Phase II trial was initiated in 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 enrolment 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** (Giotrif®/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 programme 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 MSD (MSD is also known as Merck in the U.S. and Canada)
Olmutinib plus afatinib** (Giotrif®/Gilotrif®)
Olmutinib plus IGF ligand-neutralizing antibody BI 836845****
Olmutinib plus oral nintedanib*** (Vargatef®)
Olmutinib plus bevacizumab (Avastin®)
* Olmutinib (BI 1482694 / HM61713) is approved in South Korea for the treatment of EGFR T790M mutation-positive lung cancer. Olmutinib is not approved in other indications and jurisdictions. Trials are ongoing and data will be submitted to other regulatory bodies in due course.
** Afatinib is approved in a number of markets, including the EU, Japan, Taiwan and Canada under the brand name Giotrif®, in the US under the brand name Gilotrif® and in India under the brand name Xovoltib® for use in patients with distinct types of EGFR mutation-positive NSCLC. Afatinib is also approved in the EU, US and other markets for the treatment of patients with advanced SqCC of the lung whose disease has progressed (on or) after treatment with platinum-based chemotherapy. Afatinib is under regulatory review by health authorities in other countries worldwide. Registration conditions differ internationally, please refer to locally approved prescribing information.
*** 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 not approved in other oncology indications. Nintedanib is under regulatory review by health authorities in other countries outside the EU.
**** BI 836845 is not approved and its efficacy and safety have not yet been fully established.
+ KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
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 more information please visit: www.boehringer-ingelheim.com
~ ENDS ~
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Boehringer Ingelheim
Corporate Communications
Media + PR
Reinhard Malin
Phone: +49 (6132) 77-90815
Fax: +49 6132 – 77 6601
Email: press@boehringer-ingelheim.com
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