Ingelheim, Germany — Boehringer Ingelheim has announced the initiation of a phase III clinical trial to investigate one of its most advanced oncology pipeline compounds, afatinib, for the treatment of patients with advanced (metastatic) breast cancer. Afatinib is an oral compound (taken as a tablet), which is a next generation, targeted therapy, that irreversibly inhibits both, the epidermal growth factor receptor (EGFR/HER1) and the human epidermal receptor HER2, which are involved in tumour growth and spread1.

This pivotal phase III clinical trial, called the “LUX-Breast 1 Trial” is the first to evaluate afatinib in breast cancer, and this investigation widens the scope of potential cancer types for which Boehringer Ingelheim’s oncology portfolio may be suitable. Afatinib is currently investigated in an extensive clinical trial programme, the LUX-Lung Programme in lung cancer. Results from LUX -Lung 1 are due to be reported this year.

LUX-Breast 1, is a global, open-label randomised phase III pivotal study in patients with advanced breast cancer after prior treatment with trastuzumab who have an over expression of the HER2 protein (HER2-positive patients). The study investigates whether treatment with afatinib can extend the lives of these patients before their cancer progresses (i.e. progression-free survival, PFS) as compared to continuing treatment with trastuzumab when both are added to the standard chemotherapy treatment vinorelbine. Overall survival, tolerability and safety will also be assessed in the study.

“We have seen positive results in our proof-of-concept studies for afatinib in breast cancer and are glad to advance the programme into pivotal phase III. We are delighted to be able to initiate this important trial together with a range of leading investigators to assess the value of afatinib for women with advanced breast cancer.” said Prof. Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim.

Breast cancer is the leading cause of cancer deaths in women globally, resulting in more than 411,000 deaths each year2. HER2-positive breast cancer is a particularly aggressive form of the disease and is associated with a greater risk of disease progression and death compared to women with HER2-negative tumours3. It is thought that in approximately 30% of advanced breast cancer cases, women overexpress the HER2 protein4.

The initiation of the LUX-Breast 1 trial represents yet another important milestone for Boehringer Ingelheim to broaden and amplify its oncology development activities beyond lung cancer, again initiating the development of a potential novel agent for the treatment of an aggressive advanced cancer type.

Advancing Boehringer Ingelheim’s oncology pipeline:

Afatinib is also being investigated for non-small cell lung cancer (NSCLC) in phase III clinical trials, the most common type of cancer5. In the LUX-Lung clinical trial programme, one of the pivotal trials, LUX-Lung 3, evaluates the efficacy and safety of afatinib compared to standard chemotherapy (cisplatin/pemetrexed) as a potential first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR mutation6. In addition in another phase III trial, LUX-Lung 1, Boehringer Ingelheim investigates afatinib versus placebo in NSCLC patients after prior EGFR inhibitor therapy7.

Afatinib is just one of Boehringer Ingelheim’s most advanced oncology pipeline compounds along with BIBF 1120*, which is in phase III development for the treatment of patients with advanced NSCLC. Furthermore, in December 2009, Boehringer Ingelheim announced the initiation of its first pivotal phase III trial of BIBF 1120 in ovarian cancer.

The ongoing phase III development of its two most advanced compounds in a number of cancer types and patient populations. Continuously, Boehringer Ingelheim’s oncology pipeline is evolving and demonstrates the company’s continued commitment to the disease area.

About afatinib (BIBW 2992, planned brand name TomtovokTM):

Afatinib is a next generation, orally administered targeted agent that irreversibly inhibits EGFR/HER1 and HER2 tyrosine kinases1, which are involved in tumour growth and spread.

The decision to progress afatinib into a phase III trial in breast cancer was based on previous positive study results, which indicated that the agent was well tolerated and induced promising early clinical responses in advanced HER2-positive breast cancer patients whose cancer had progressed following treatment with trastuzumab; manageable cutaneous adverse events and diarrhoea were the main side-effects8.