Boehringer Ingelheim Initiates Phase III Clinical Trial with Novel Oral Agent in Advanced Breast Cancer

Boehringer Ingelheim today 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 spread i.
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 I, 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 year ii. 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 tumours iii. It is thought that in approximately 30% of advanced breast cancer cases, women overexpress the HER2 protein iv.
The initiation of the LUX-Breast I 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.
**Published in "PharmPro"