Afatinib*, Boehringer Ingelheim's investigational compound, demonstrates progression free survival of almost one year in patients with EGFR mutation positive, advanced non-small cell lung cancer in pivotal phase III trial

LUX-Lung 3 trial results highlighted at the official ASCO Press Conference: Afatinib* delays lung cancer progression compared to standard chemotherapy

BURLINGTON, ON, June 4, 2012 /CNW/ - The LUX-Lung 3 Phase III results showed that lung cancer patients taking the novel compound afatinib*, an irreversible ErbB Family Blocker, as a first-line treatment, lived for almost one year before their disease progressed (progression-free survival (PFS) of 11.1 months) versus just over half a year (PFS of 6.9 months) for those on standard chemotherapy (pemetrexed / cisplatin)¹.

Importantly, patients taking afatinib* with EGFR mutations (del19 and L858R, accounting for 90% of all EGFR mutations studied in the trial) lived for well over a year without progression (PFS of 13.6 months) versus just over half a year (PFS of 6.9 months) for those in the comparator arm².

"Increasingly, we are now considering a more personalized approach to managing lung cancer,"  says Dr. Natasha Leighl, medical oncologist at the Princess Margaret Hospital and President of Lung Cancer Canada. "We've found that patients with specific genetic mutations - like in the EGFR gene - will respond better to certain therapies. With this in mind, it's important that all Canadians with non-small cell lung cancer be tested for their mutation status at diagnosis, similar to the way breast cancer patients are tested for their genetic mutation status at diagnosis, so that patients and their oncologists can make informed treatment decisions."

Boehringer Ingelheim's pivotal phase III trial LUX-Lung 3 is investigating the company's molecule afatinib*, and is the largest and most robust pivotal phase III clinical trial to date in EGFR (ErbB1) mutation positive advanced lung cancer patients. The primary endpoint was progression-free survival (PFS).

Full data from the trial will be presented today in a late-breaking oral presentation at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

"Not only did LUX-Lung 3 meet its primary endpoint, but it also showed that afatinib*, especially in patients with EGFR mutations, almost doubled the progression free survival time compared to chemotherapy." commented Prof. James Chih-Hsin Yang, Director of the Cancer Research Center, College of Medicine, National Taiwan University, Taipei, Taiwan and principal investigator of the LUX-Lung 3 trial. "Based on this proven efficacy in the largest and most robust registration trial, coupled with its novel mode of action, afatinib* may become one of the most valuable treatment options for this distinct patient population."

The most common drug-related adverse events observed in the afatinib* treatment arm were diarrhea (95%), rash (62%), and paronychia (57%).  The most common drug-related adverse events observed in the chemotherapy arm (pemetrexed /cisplatin) were nausea (66%), decreased appetite (53%), and vomiting (42%).  There was a low discontinuation rate associated with treatment-related adverse events in the trial (8% discontinuation rate for afatinib; 12% for chemotherapy).  One percent of patients in the afatinib* arm discontinued due to diarrhea³.

"Survival rates for patients with non-small cell lung cancer are dissapointingly low, which is why new treatments, like afatinib, that effectively target specific genetic mutations, in this case in the EGFR gene, are desperately needed," adds Dr. Normand Blais, medical oncologist and director of the thoracic oncology program at the Centre Hospitalier Université de Montréal.

Afatinib* is different from currently available targeted therapies in that it irreversibly blocks the ErbB Family of receptors, meaning afatinib* blocks EGFR (ErbB1) as well as the other relevant members of the ErbB Family, all of which can be involved in pathways that help tumour cells grow, migrate and metastasize.

"Data from LUX-Lung 3 show that in patients with EGFR genetic mutations, afatinib demonstrated a significant and clinically meaningful delay in the progression of NSCLC, compared with combination pemetrexed and cisplatin," said Berthold Greifenberg, MD, Vice President, Clinical Development and Medical Affairs, Oncology, Boehringer Ingelheim Pharmaceuticals, Inc.  "These results add to the growing body of evidence supporting EGFR testing as an opportunity to inform and personalize the treatment of patients with EGFR mutation-positive NSCLC.  This further underscores Boehringer Ingelheim's commitment to advancing the research and development of its compounds with the goal of improving the lives of patients with cancer."

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 comparator⁴.

About Lung Cancer in Canada
According to the Canadian Cancer Society, in 2012 an estimated 25,600 Canadians will be diagnosed with lung cancer⁵, and 20,100 will die from it⁶. In fact, more people are estimated to die from lung cancer in 2012 than from colorectal, breast and prostate cancer combined⁷. As the leading cause of cancer death in both men and women in Canada⁸, an average of 55 Canadians die from lung cancer every day⁹.

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 deaths¹⁰.

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.

*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.

For more information please visit www.boehringer-ingelheim.ca

References
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¹ Abstract 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 48^th Annual Meeting of the American Society of Clinical Oncology (ASCO) 2012.

² Ibid.

³ Ibid.

⁴ Ibid.

⁵ Canadian Cancer Society's Steering Committee: Canadian Cancer Statistics 2012. Toronto, ON: Canadian Cancer Society; 2012, Page 8.

⁶ Canadian Cancer Society's Steering Committee: Canadian Cancer Statistics 2012. Toronto, ON: Canadian Cancer Society; 2012, Page 9.

⁷ Ibid.

⁸ Canadian Cancer Society's Steering Committee: Canadian Cancer Statistics 2012. Toronto, ON: Canadian Cancer Society; 2012, Page 7.

⁹ Canadian Cancer Society's Steering Committee: Canadian Cancer Statistics 2012. Toronto, ON: Canadian Cancer Society; 2012, Page 9.

¹⁰ Charity Intelligence Canada: Cancer in Canada. April 2011. Page 39.

Morgan Cates
Environics Communications
416-969-2789
[email protected]