The Lancet Oncology publishes head-to-head study comparing first and second generation targeted therapies in treatment of EGFR-mutation positive non-small cell lung cancer

Burlington, ON – May 9, 2016 – One in four Canadians said they are a lot more hopeful about a lung cancer diagnosis today versus five years ago, according to a new poll.¹; And, thanks to new advances in research on Canada’s number one cancer killer,² the scientific community is making progress to better understand the disease. A new study published in The Lancet Oncology reveals the results of the first-ever global head-to-head comparison of afatinib to gefitinib as first-line treatment for patients whose tumours have the most common epidermal growth factor receptor (EGFR) mutations (del19 or L858R).

The study, known as LUX-Lung 7, was a randomized, head-to-head, Phase IIb trial comparing the first and second generation targeted therapies for the treatment of EGFR mutation-positive non-small cell lung cancer (NSCLC). The study showed that compared to gefitinib, afatinib* significantly improved:³

•Progression free survival (PFS) (co-primary endpoint; HR=0.73; 95 per cent CI, 0.57‒0.95; p=0.017; median: 11.0 months [afatinib] versus 10.9 months [gefitinib]).⁴  PFS became more pronounced over time- after two years of treatment, more than twice as many patients on afatinib were progression free compared with those on gefitinib (after 18 months; 27.3 per cent [afatinib] versus 15.2 per cent [gefitinib]) and after 24 months; 17.6 per cent [afatinib] versus 7.6 per cent [gefitinib]).⁵ The improvement in PFS with afatinib was consistent across pre-defined clinical subgroups, including gender, age, race and EGFR mutation type.
•Time to treatment failure (co-primary endpoint; HR=0.73; 95 per cent CI, 0.58‒0.92; p=0.0073; median: 13.7 months [afatinib] versus 11.5 months [gefitinib]), reducing the treatment failure by 27 per cent versus gefitinib.⁶ This was consistent across various subgroups, including EGFR mutation subgroups, race, gender and age.⁷
•Objective response rate (secondary endpoint; 70 per cent [afatinib] versus 56 per cent [gefitinib], p=0.0083). Patients experienced greater tumour shrinkage with afatinib versus gefitinib with median duration of response of 10.1 months and 8.4 months respectively.⁸

Both afatinib* and gefitinib demonstrated similar improvements in patient-reported outcome measures with no significant differences in health-related quality of life.⁹

This is good news for the lung cancer community including Fernando Aramburu and his wife Michelle from Calgary. Fernando was diagnosed with stage IV lung cancer in April 2015. “Fernando has been taking afatinib since May 2015,” says Michelle. “We know first-hand the importance of new treatment advances and we want others to know that there is hope.”

However, a new poll shows there is room for education because 40 per cent of Canadians surveyed say they feel lung cancer is a death sentence.¹⁰ The survey also revealed Canadians are completely unaware of the specifics of the disease. For example, one in three don’t know there are different types of lung cancer¹¹ and almost half (49 per cent) don’t know that cancer patients with certain genetic mutations can be treated with targeted drugs that can provide better results than other treatment options.¹²

“The LUX-Lung 7 trial results give oncologists more insights into first versus second generation treatments for non-small cell lung cancer,” says Dr. Sunil Yadav, Medical Oncologist at the Saskatoon Cancer Center.  “For the first time, we now have head-to-head data on the efficacy and safety provided by these two important treatments and specifically what treatment will work best for patients with an EGFR genetic mutation – which make up about 20 per cent of all lung cancer patients.”¹³
“This trial points to the need for continued research and innovation in this particular area of oncology.” says Shem Singh, Executive Director, Lung Cancer Canada. “As lung cancer is the leading cause of cancer death in Canada, new approaches to treatment are important for extending survival while maintaining quality of life.”

About Lung Cancer
According to the Canadian Cancer Society, in 2015 an estimated 26,600 Canadians were diagnosed with lung cancer, and 20,900 died from it.¹⁴ More than half of new cancer cases (51 per cent) were lung, breast, colorectal and prostate cancer.¹⁵ Lung cancer is the leading cause of cancer death, causing more cancer deaths among Canadians than the other three cancer types combined.¹⁶ As the leading cause of cancer death in both men and women in Canada,¹⁷, it’s estimated an average of 57 Canadians die from the disease every day.¹⁸
 
Lung cancer is also grossly under researched and under-funded. In 2011, it received only 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.¹⁹

About LUX-Lung 7²⁰
A total of 319 patients from 64 sites in 13 countries with stage IIIb/IV EGFR mutation-positive NSCLC, who received no prior treatment, were randomized (1:1) to daily afatinib 40 mg or gefitinib 250 mg. Patients were stratified by mutation type (Del19 or L858R) and the presence of brain metastases.

Treatment continued until disease progression or beyond if deemed beneficial by the investigator. Co-primary endpoints were: progression free survival by independent review, time to treatment failure, and overall survival. Secondary endpoints included objective response rate, disease control rate, tumor shrinkage, and longitudinal change from baseline in health-related quality of life.

Adverse events (AEs) in the trial were consistent with the known safety profiles of both treatments.; Treatment with both afatinib and gefitinib were generally tolerable, leading to an equally low rate of treatment-related discontinuation in both arms (6 per cent).²¹ The overall frequency of serious AEs was similar for both (44.4 per cent [afatinib] versus 37.1 per cent [gefitinib]).²² The most common grade ≥3 related AEs with afatinib were: diarrhea (13 per cent) and rash/acne (9 per cent), and with gefitinib:  (AST)/alanine aminotransferase (ALT) increase (9 per cent). Drug-related interstitial lung disease was reported for four patients on gefitinib and no patients on afatinib.²³

About Afatinib²⁴
Afatinib was approved by Health Canada in 2013 as GIOTRIF and is indicated as monotherapy for the treatment of Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor naïve patients with metastatic (including cytologically proven pleural effusion) adenocarcinoma of the lung with activating EGFR mutation(s).

Poll Methodology
This poll was conducted by Environics Research Group through an online survey of 1,035 adults from February 17th to February 19th, 2016. In order to qualify for this survey respondents had to be 18 years of age or older and reside in Canada.

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 145 affiliates and a total of more than 47,500 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative “Making more Health” and caring for employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2015, Boehringer Ingelheim achieved net sales of about 14.8 billion euros. R&D expenditure corresponds to 20.3 per cent of its net sales.

The Canadian headquarters of Boehringer Ingelheim was established in 1972 in Montreal, Quebec and is now located in Burlington, Ontario. Boehringer Ingelheim employs approximately 600 people across Canada.

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

For more information, please contact:
Sheba Zaidi
Environics Communications
416-969-2652 / szaidi@environicspr.com

Jennifer Mota
Boehringer Ingelheim (Canada) Ltd.
905 631-4739 / Jennifer.mota@boehringer-ingelheim.com