Also announced - new head-to-head trials, LUX-Lung 7 and LUX-Lung 8, initiated to further evaluate afatinib in non-small cell lung cancer (NSCLC)
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Highly anticipated results from LUX-Lung 3, the pivotal Phase III lung cancer trial investigating Boehringer Ingelheim's front running oncology investigational compound, the ErbB Family Blocker afatinib, in patients with EGFR mutations, will be presented at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from 1 - 5 June 2012. LUX-Lung 3, which compares afatinib to standard platinum based chemotherapy, is the largest Phase III trial in first-line EGFR mutation positive, advanced, metastatic non-small cell lung cancer (NSCLC) patients.1 LUX-Lung 3 is also the first study using pemetrexed/cisplatin as a comparator.
Comprehensive data from 16 abstracts in both late and early Phase clinical trials will be presented at ASCO demonstrating Boehringer Ingelheim´s ongoing commitment to delivering innovative cancer therapies to patients. The presentation of the LUX-Lung 3 trial1 in particular will shed light on the results for afatinib as a first-line treatment for those NSCLC patients who harbour a mutation in their Epidermal Growth Factor Receptor genes (EGFR M+), a distinct or specific patient population who is known to respond differently to targeted therapies (e.g. Tyrosine Kinase Inhibitors).
The LUX-Lung 3 results will be presented as a late breaking oral presentation on Monday 4 June at 15:00 Central Daylight Time / 22:00 Central European Time.
“We are excited to present the results of this pivotal Phase III trial, the largest and most robust of its kind,” said Prof. Dr. Gerd Stehle, VP and Therapeutic Area Head of Oncology at Boehringer Ingelheim. “As we are continuously advancing the development of our irreversible ErbB Family Blocker, we have initiated two additional trials, LUX-Lung 7 and 8, to further assess the potential benefit of afatinib in patients with NSCLC. These are all important steps in establishing personalised care for lung cancer patients and it highlights the importance of early assessment of EGFR mutation status.”
The two newly initiated trials are currently recruiting patients. LUX-Lung 7 is a Phase IIb trial evaluating afatinib head-to-head versus gefitinib as a first-line treatment in EGFR mutation positive NSCLC patients. LUX-Lung 8 is a Phase III trial evaluating afatinib head-to-head versus erlotinib in second-line treatment of squamous cell carcinoma of the lung. Genome research in oncology in recent years has revealed that NSCLC patients with EGFR mutations need to be considered a distinct group of NSCLC patients, who require a different treatment approach for more effective outcomes.
Notes to editors
BI Oncology at ASCO 2012: Late Breaking Oral Presentation
LUX-Lung 3: A randomised, open-label, Phase III study of afatinib versus chemotherapy (cisplatin /pemetrexed) as first-line treatment for patients with advanced adenocarcinoma of the lung harbouring EGFR activating mutations. (Monday 4 June at 15:00 Central Daylight Time / 22:00 Central European Time).
Afatinib*
Afatinib* is an irreversible ErbB Family Blocker which inhibits signal transduction of all kinase receptors from the ErbB Family2 , which is known to play a critical role in the growth and spread of the most pervasive cancers and cancers associated with high mortality (lung, breast, and head & neck cancers). A mutation of the Epidermal Growth Factor Receptor (EGFR, also referred to as ErbB1) is found in 10-15% of Caucasian and in 30-40% of Asian NSCLC patients.3
The LUX-Lung trial program on clinicaltrials.gov
LUX-Lung 3: A randomised, open-label, Phase III study of afatinib versus chemotherapy (cisplatin /pemetrexed) as first-line treatment for patients with advanced adenocarcinoma of the lung harbouring EGFR activating mutations http://clinicaltrials.gov/ct2/show/NCT00949650?term=afatinib+chemotherapy+adenocarcinoma&rank=1
LUX-Lung 7: A randomised, open-label, Phase IIb trial of afatinib versus gefitinib as first-line treatment of patients with EGFR mutation positive advanced adenocarcinoma of the lung http://clinicaltrials.gov/ct2/show/NCT01466660?term=lux+lung&rank=4
LUX-Lung 8: A randomised, open-label, Phase III trial of afatinib versus erlotinib in patients with advanced squamous cell carcinoma of the lung as second-line therapy following first-line platinum-based chemotherapy http://clinicaltrials.gov/ct2/show/NCT01523587?term=lux+lung&rank=2
About Lung Cancer
Lung cancer is the most common and most deadly form of cancer in the world: it accounts for 1.6 million new cancer cases annually. Because of its poor prognosis, 1.38 million deaths each year are attributable to lung cancer.4 Overall, lung cancer is the cause of 18% of all cancer deaths.4 Thirteen percent of all new cases of cancer are lung cancers5 and smoking is attributed as the main cause.6
About Boehringer Ingelheim in Oncology
Building on scientific expertise and excellence in the fields of pulmonary and cardiovascular medicine, metabolic disease, neurology, virology and immunology, Boehringer Ingelheim has embarked on a major research programme to develop innovative cancer drugs. Working in close collaboration with the international scientific community and a number of the world’s leading cancer centres, Boehringer Ingelheim’s commitment to oncology is underpinned by using advances in science to develop a range of targeted therapies for various solid tumours and haematological cancers.
The current focus of research includes compounds in three areas: angiogenesis inhibition, signal transduction inhibition and cell-cycle kinase inhibition. Nintedanib* (BIBF 1120) is currently in Phase III clinical development in NSCLC and ovarian cancer. Afatinib* is currently in Phase III clinical development in NSCLC, breast cancer and head and neck cancer. In the area of cell-cycle kinase inhibition, Boehringer Ingelheim is developing an inhibitor of polo-like kinase 1 (Plk1), volasertib*, a protein that is involved in the processes of cell division. The compound is in Phase II development for acute myelogenous leukemia.
Boehringer Ingelheim’s oncology pipeline is evolving and demonstrates the company’s continued commitment to the disease area.
Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 42,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavors.
In 2010, Boehringer Ingelheim posted net sales of about 12.6 billion euro while spending almost 24% of net sales in its largest business segment Prescription Medicines on research and development. Updated information on the corporation’s annual results in 2011 will be available on April 24th, 2012.
For more information please visit: www.boehringer-ingelheim.comand www.thewhiteroom.info
References
1Abstract no: LBA7500, LUX-lung 3: A randomized, open-label, phase III study of afatinib versus pemetrexed and cisplatin as first-line treatment for patients with advanced adenocarcinoma of the lung harboring EGFR-activating mutations. Oral Presentation at 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) 2012.
2Boehringer Ingelheim, data on file.
3Jang, T.W. et al. EGFR and KRAS Mutations in Patients With Adenocarcinoma of the Lung. The Korean Journal of Internal Medicine, March 2009; 24(1), pp.48–54.
4Ferlay J et al. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer 2010; EPub Ahead of print.
5Cancer Research UK. UK lung cancer incidence. CancerStats – Key Facts 2009. [Online] Available at: http://info.cancerresearchuk.org/cancerstats/types/lung/incidence/[Last Accessed April 2012].
6Allen J et al. J Natl Compr Canc Netw 2008;6(3): 285-293.
*Afatinib, nintedanib (BIBF 1120) and volasertib are investigational compounds. Their safety and efficacy have not yet been fully established.
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