New data from the LUX-Lung 3 trial for afatinib, Boehringer Ingelheim's investigational compound, presented at the European Society for Medical Oncology (ESMO) 2012 Congress
BURLINGTON, ON, Oct. 19, 2012 /CNW/ - Data from LUX-Lung 3, the largest and most robust pivotal phase III clinical trial to date1 in first-line patients with epidermal growth factor receptor (EGFR) (ErbB1) mutation positive non-small cell lung cancer (NSCLC) shows that the novel compound afatinib*, an irreversible ErbB Family Blocker, leads to better and longer control and improvement of the most common lung cancer-related symptoms leading to better quality of life (QoL) compared to best-in-class standard chemotherapy (pemetrexed and cisplatin).1,2 These findings further reinforce the first-line efficacy of afatinib* in patients with EGFR mutation positive NSCLC.
Analyses of patients' questionnaires for three pre-specified lung cancer symptoms (cough, dyspnoea and pain) showed that more afatinib*-treated patients experienced improvements in dyspnoea or shortness of breath (64% vs. 50%; p=0.0103), pain (59% vs. 48%; p=0.0513) and cough (67% vs. 60%; p=0.2444).3 Afatinib also delayed the time to deterioration for cough (HR=0.60; p=0.007) and dyspnoea (HR=0.68; p=0.0145) versus chemotherapy.4 Importantly afatinib* treatment led to improved physical, role and cognitive functioning, and better overall QoL.5
"Following encouraging data presented earlier this year, the new data demonstrate that the positive progression-free survival outcomes with afatinib* also translate into additional benefits for patients in terms of quality of life and control and improvement of symptoms," commented Dr Vera Hirsh, Associate Professor, McGill University, Department of Medical Oncology, Royal Victoria Hospital, Montreal, Canada. "This further supports the potential of this treatment option in first-line treatment of metastatic NSCLC to effectively help those patients harbouring EGFR mutations."
Previously presented LUX-Lung 3 trial data has shown that patients taking afatinib* as a first-line treatment lived for almost one year without their tumour growing again (median progression-free survival (PFS) of 11.1 months) versus just over half a year (PFS of 6.9 months) for those treated with pemetrexed / cisplatin.6 Furthermore, NSCLC patients with tumours harbouring the two most common EGFR mutations taking afatinib* lived for well over a year without tumour progression (PFS of 13.6 months) versus just over half a year (PFS of 6.9 months) for those in the comparator arm.7 Patients with common EGFR mutations who experienced greater progression free survival benefit also experienced a greater benefit in health-related QoL, symptom control and symptom improvement.8
Afatinib is an irreversible ErbB Family Blocker, thus it differs from currently available targeted therapies in that it irreversibly and completely inhibits ErbB receptor signal transduction, blocking the key pathways that help tumour cells grow, migrate and metabolise.9 This novel mode of action may lead to a distinct therapeutic benefit and has provided the basis for initiation of the LUX-Lung trial program.1
Notes to Editors
About LUX-Lung 3 Trial
LUX-Lung 3 is a large, randomized, open-label, Phase III registration study comparing afatinib* to two chemotherapy agents, pemetrexed and cisplatin, as first-line treatment for patients with stage IIIb or IV NSCLC harbouring an EGFR mutation. The study included 345 patients with EGFR mutation positive NSCLC globally. LUX-Lung 3 is the largest pivotal phase III trial to date in patients with EGFR mutation positive advanced, metastatic NSCLC and the first study in this population to use pemetrexed / cisplatin as a comparator.11
As previously reported, the study met its primary endpoint of PFS with afatinib versus chemotherapy (11.1 versus 6.9 months, respectively) in patients with EGFR mutation-positive advanced NSCLC. The most common drug-related adverse events observed with afatinib were diarrhea (95%), rash (62%), and paronychia (57%). The most common drug-related adverse events observed with chemotherapy (pemetrexed/cisplatin) were nausea (66%), decreased appetite (53%), and vomiting (42%).12
About Lung Cancer in Canada
According to the Canadian Cancer Society, in 2012 an estimated 25,600 Canadians will be diagnosed with lung cancer,13 and 20,100 will die from it.14 In fact, more people are estimated to die from lung cancer in 2012 than from colorectal, breast and prostate cancer combined.15 Lung cancer is the leading cause of cancer death in both men and women in Canada.16
Lung cancer is also grossly under researched and under-funded. It only gets 7 per cent of cancer-specific research funding and 0.1 per cent of cancer donations, despite the fact that it causes 27 per cent of cancer-related deaths.17
About Afatinib*
Afatinib* is an investigational oral, once-daily, irreversible ErbB Family Blocker that specifically inhibits epidermal growth factor receptor (EGFR or ErbB1), human epidermal receptor 2 (HER2 or ErbB2) and ErbB42, 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). Afatinib* is currently also in Phase III clinical development in breast cancer and head and neck cancer. Afatinib* is currently not authorized for sale by Health Canada; its safety and efficacy has not been established.
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. BIBF 1120, an angiogenesis inhibitor is currently in Phase III clinical development in NSCLC and ovarian cancer. In the area of cell-cycle kinase inhibition, Boehringer Ingelheim is developing an inhibitor of polo-like kinase 1 (Plk1), a protein that is involved in the processes of cell division. The compound is in Phase II development for acute myeloid leukaemia.
Boehringer Ingelheim's oncology pipeline is evolving and demonstrates the company's continued commitment to advance the disease area.
About Boehringer Ingelheim (Canada) Ltd.
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 44,000 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 endeavours.
In 2011, Boehringer Ingelheim posted net sales of 13.2 billion euro while spending almost 24% of net sales in its largest business segment Prescription Medicines on research and development.
The Canadian headquarters of Boehringer Ingelheim was established in 1972 in Burlington, Ontario, Canada and the Research and Development Centre is located in Laval, Québec, Canada. Boehringer Ingelheim (Canada) Ltd. is home to more than 750 employees including 170 scientists across the country.
For more information please visit www.boehringer-ingelheim.ca
References
a LUX-Lung 3 included 345 patients in 133 sites in 25 countries. Results were independently reviewed. The chemotherapy arm was cisplatin / pemetrexed, considered the most efficacious platinum doublet chemotherapy in advanced and metastatic lung cancer.2 The trial prospectively selected EGFR (ErbB1) mutations, rather than retrospectively. The trial was the largest trial conducted in lung cancer patients with EGFR (ErbB1) mutations. The trial included patients from all over the world including Caucasians and Asians.
*Afatinib is an investigational compound.
Its safety and efficacy has not yet been fully established and it is currently not authorized for sale in Canada.
Image with caption: "Dr. Vera Hirsh, Associate Professor at McGill University and the Department of Medical Oncology at Royal Victoria Hospital in Montreal (CNW Group/Boehringer Ingelheim) (CNW Group/Boehringer Ingelheim (Canada) Ltd.)". Image available at: http://photos.newswire.ca/images/download/20121019_C8507_PHOTO_EN_19568.jpg
Audio with caption: "Dr. Vera Hirsh talks about new data from a LUX-Lung 3 trial for afatinib, Boehringer Ingelheim's investigational compound, presented at the European Society for Medical Oncology (ESMO) 2012 Congress". Audio available at: http://stream1.newswire.ca/media/2012/10/19/20121019_C8507_AUDIO_EN_19569.mp3
SOURCE: Boehringer Ingelheim (Canada) Ltd.
Morgan Cates
Environics Communications
416-969-2789
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