Boehringer Ingelheim announced the launch of the ELUXA clinical research program for study of Olmutinib in treatment of metastatic non-small cell lung cancer as a monotherapy, and combination therapy. It is planned to study the therapeutic efficacy of Olmutinib in combination with immuno-oncological drugs such as Keitruda®+, c second-generation tyrosine kinase inhibitor Gyrotrif®, with anti-angiogenic drugs Vargatef® and Avastin® and an experimental preparation of Boehringer Ingelheim with a monoclonal antibody to IGF BI 836845.
Program Clinical studies include ELUXA 1 and Phase III studies that will be launched in the near future
Boehringer Ingelheim has launched the ELUXA clinical research program to further study the therapeutic efficacy of Olmutinib (BI 1482694 / HM61713), a new third generation tyrosine kinase inhibitor (TCR) active in certain epidermal growth factor receptor (EGFR) mutations, for the treatment of EGFR-positive non-small cell lung cancer (NSCLC). The company will comprehensively study olmutinib as a monotherapy, as well as in combination with experimental and approved antitumor drugs, such as pembolizumab (Keitruda®+) of MSD-anti-PD-1 monoclonal antibody. In the development of Olmutinib,an EGFR tyrosine kinase inhibitor of the third generation, the need to develop new, necessary methods for treating patients who progressed the disease during or after therapy with an EGFR tyrosine kinase inhibitor of the first or second generation was considered. The possibility of their use as new variants of the first line of therapy is currently being investigated.
The ELUXA clinical research program was developed based on the results of a clinical study of the I / II phase of HM-EMSI-101 evaluating olmutinib in EGFR-positive lung cancer resistant to the first line of TIC therapy. This study was the basis for the first registration of Olmutinib in South Korea. An updated analysis of this study was presented at ASCO, 2016.
Dr Mehdi Shahidi, medical director of the solid tumor department at Boehringer Ingelheim, said: "Given the encouraging results of the effectiveness of olmutinib in patients with EGFR-positive NSCLC, we are proud to announce our comprehensive ELUXA clinical research program. To apply our experience in this field, accumulated during the ongoing research aphatiniba as part of the clinical research program LUX-Lung and launch another comprehensive clinical research program. The purpose of the ELUXA program is to provide a new opportunity for the treatment of metastatic NSCLC EGFRM+, to ultimately improve the results of treatment of patients with lung cancer who have progressed to the disease during or after therapy with an EGFR tyrosine kinase inhibitor. "
Olmutinib will be evaluated as a monotherapy in the following studies:
· ELUXA 1 (HM-EMSI-202): The Phase II study was started in July 2015 to assess the safety and efficacy of olmutinib in patients with metastatic NSCLC with the positive status of the epidermal growth factor receptor (TGFR) T790M mutation, which progressed the disease during or after therapy with the EGFR tyrosine kinase inhibitor. The study set is complete. It includes more than 150 patients worldwide and is the basis for an application submitted to the regulatory authorities.
· ELUXA 2: The Phase III study will be launched in 2016 to investigate the efficacy and safety of olmutinib compared to standard platinum-based chemotherapy regimens in patients with metastatic NSCLC with a positive T790M mutation status EGFR, and with the progression of the disease after previous therapy by the ITF EGFR.
· ELUXA 3: A direct phase III comparative trial will be started in 2016 to study olmutinib as the first line of therapy compared to the second generation EGFR aphatinib (Gyrotrif®) in patients with NSCLC and EGFR-positive status.
· ELUXA 4: Phase I / II study in Japanese patients with NSCLC with the positive status of EGFR T790M mutation will be started in 2016.
· ELUXA 6: Phase II trial in which a prospective blood biomarker assay will be conducted for the first time to select patients with NSCLC with a positive mutation status of EGFR T790M, when a puncture biopsy can not be performed.
Considering changes in the tactics of managing lung cancer patients, developing new treatments and the rapid evolution of biomarker analysis, Boehringer Ingelheim seeks to explore how treatment options can be combined to develop more effective therapy. Focusing on multiple mechanisms of oncogenesis, studies show that combination therapy can overcome drug resistance and more effectively control the tumor process, providing better outcomes for patients.
Clinical studies of the ELUXA program will evaluate olmutinib in NSCLC and the positive status of EGFR mutations in combination with Boehringer Ingelheim preparations and preparations of other pharmaceutical manufacturers. These studies will include:
· Olmutinib in combination with pembolizumab (Keitruda®+) - in cooperation with MSD (Merck in the USA and Canada)
· Olmutinib + apathinib (Gyrotrif®)
· Olmutinib + antibodies neutralizing the IGF ligand BI 836845
· Olmutinib + nintedanib (Vargatef®)
· Olmutinib + bevacizumab (Avastin®)
About drugs of oncological direction
Olmutinib (BI 1482694 / HM61713) has been approved in South Korea for the treatment of NSCLC with the positive status of the EGFR T790M mutation. Olmutinib is not approved for other indications and countries. Studies are currently ongoing, and the data will be presented to other regulatory authorities in the prescribed manner.
Afatinib approved in a number of countries, including the EU, Japan, Taiwan and Canada under the trade name Gyrotrif®, in the USA under the trade name of Gilotriff® and in India under the trade name Xowoltib® for use in patients with different types of EGFR-positive NSCLC. Afatinib is also approved in the EU, the US and other countries for the treatment of patients with locally advanced or metastatic squamous NSCLC, with progression on the background or after chemotherapy on the basis of platinum preparations.
Nintedanib is approved in the EU under the trade name Vargatef® for use in combination with docetaxel in adult patients with locally advanced, metastatic or locally recurring NSCLC, the histological type of adenocarcinoma, after first-line chemotherapy.
BI 836845 is an experimental drug, efficacy and safety that is evaluated in clinical trials.
+ KEITRADA® is a registered trademark of Merck Sharp & Dohme Corp. (a subsidiary of Merck & Co., Inc.)