Boehringer Ingelheim LUX-Breast 1 and LUX-Breast 3 data at San Antonio Breast Cancer Symposium (SABCS)

Ingelheim, Germany, 12 December 2014 – Boehringer Ingelheim today presented results from two trials investigating afatinib* in the treatment of breast cancer, at the 2014 San Antonio Breast Cancer Symposium (SABCS).

The Phase III LUX-Breast 1 trial, comparing afatinib* plus vinorelbine (experimental arm) with trastuzumab plus vinorelbine in patients with HER2-positive metastatic breast cancer after failure of prior trastuzumab-based therapy, showed similar progression-free survival and objective response in both treatment arms, but shorter overall survival in the experimental arm.¹ The most common adverse events were diarrhoea, neutropenia and rash with afatinib* plus vinorelbine, and neutropenia, leukopenia and anaemia with trastuzumab plus vinorelbine.¹ The combination of afatinib* plus vinorelbine was less tolerable with a higher rate of dose reductions and treatment discontinuations compared to trastuzumab plus vinorelbine.¹ The trial closed for recruitment in April 2013, following the recommendation of the independent Data Monitoring Committee (DMC). Patients who received afatinib* plus vinorelbine therapy were offered alternative treatments. Based on these results, Boehringer Ingelheim discontinued recruitment into all trials investigating afatinib* plus vinorelbine in HER2-positive metastatic breast cancer.

Data from LUX-Breast 3, a randomised, open-label Phase II trial in patients with HER2-positive breast cancer progressing with brain metastases, were also presented at SABCS. The three-armed trial compared afatinib*, afatinib* plus vinorelbine and investigator’s choice of therapy, after prior trastuzumab and/or lapatinib-based therapy. The data showed no benefit for afatinib*-containing regimens over treatments selected by the physician as measured by the primary endpoint of patient benefit at 12 weeks and secondary endpoints including progression-free survival and overall survival.²

About afatinib
*Afatinib is approved in a number of markets, including the EU, Japan, Taiwan and Canada under the brand name GIOTRIF^® and in the U.S. under the brand name GILOTRIF^® for use in patients with distinct types of EGFR mutation-positive non-small cell lung cancer (NSCLC). Registration conditions differ internationally, please refer to locally approved prescribing information. Afatinib is under regulatory review by health authorities in other countries worldwide. Afatinib is not approved in other indications.

Approval of afatinib for the treatment of distinct types of EGFR mutation-positive NSCLC was based on the results of LUX-Lung 3 which met its primary end point of progression-free survival. In the LUX-Lung 3 trial, which is part of the LUX-Lung clinical trial programme, afatinib significantly delayed tumour growth when compared to standard chemotherapy.³ In addition, data from the LUX-Lung 3 and 6 trials demonstrated that afatinib is the first treatment to show an overall survival benefit (secondary endpoint) for a subgroup of patients with a specific type of EGFR mutation-positive NSCLC compared to chemotherapy.⁴ A significant overall survival benefit was demonstrated in both individual trials for patients with the most common EGFR mutation (exon 19 deletion; del19) compared to chemotherapy.⁴

The study programme evaluating afatinib in a number of indications is ongoing and will provide more clinical data in order to further establish the efficacy and safety profile of this compound.

About Boehringer Ingelheim in Oncology
Boehringer Ingelheim in Oncology

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 142 affiliates and a total of more than 47,400 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.

Taking 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 the 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 2013, Boehringer Ingelheim achieved net sales of about 14.1 billion euros. R&D expenditure corresponds to 19.5% of its net sales.

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