Friday, May 16, 2014

New Analysis Shows Boehringer Ingelheim’s Giotrif® (afatinib) is the First Treatment to Demonstrate Significant Overall Survival Benefit for Patients with a Specific Type of Lung Cancer

ME NewsWire/ Business Wire

INGELHEIM, Germany - Thursday, May 15th 2014

    Overall survival results from a post-hoc analysis combining the data of two Phase III studies (LUX-Lung 3 and LUX-Lung 6) demonstrate that first-line afatinib treatment reduced the risk of death by 19% for patients with lung cancer with common types of EGFR mutations.1
    Patients lived a median of three months longer if they started treatment with afatinib rather than chemotherapy.1
    A separate Phase III study (LUX-Lung 5) in patients whose lung cancer progressed after several treatments, showed the advantage of continuing afatinib with chemotherapy after the tumours started to grow under afatinib alone.2

For Ex-US and Ex-UK Media Only

Boehringer Ingelheim today announced new overall survival results from a post-hoc analysis combining the data of two Phase III trials (LUX-Lung 3 and LUX-Lung 6). The analysis showed patients with non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations (exon 19 deletions or exon 21 [L858R] substitutions) lived longer if treated with first-line afatinib compared to chemotherapy.1 An oral presentation at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO), on June 2nd (3:00 - 6:00 PM, E Hall D2; Abstract #8004, scheduled for 4:00 - 4:12 PM) will discuss these data in more depth, providing further insights into their impact on clinical practice and patient care. Data from 6 other abstracts involving afatinib and other compounds in Boehringer Ingelheim’s oncology portfolio, will also be presented or published at ASCO in Chicago, May 30-June 3.

Overall survival results1

In the combined analysis from two of the largest trials in this patient population, afatinib prolonged survival of lung cancer patients whose tumours harbour common EGFR mutations compared with standard chemotherapy by a median of 3 months (27.3 compared to 24.3 months), significantly reducing the risk of death by 19%. The most pronounced reduction in risk of death, by 41%, was noted for patients whose tumours have the most common type of EGFR mutation (deletion in exon 19 of the EGFR gene). See abstract #8004 for full details. The conclusions of this analysis further substantiate earlier published results on delay in tumour growth (progression-free survival), better control of lung cancer symptoms and adverse events associated with afatinib in comparison with standard chemotherapy.

Commenting on the overall survival results, principal investigator Professor James Chih-Hsin Yang, M.D., Ph.D., National Taiwan University Hospital in Taiwan, said: “The results of two afatinib trials independently show for the first time that despite cross-over in subsequent treatment, front-line use of a targeted treatment can prolong overall survival in patients with deletion 19 EGFR mutation-positive lung cancer compared to chemotherapy. The results add to the list of benefits already shown in these studies, which include improvements in tumour shrinkage, longer duration of disease control and in life-restricting, disease-related symptoms such as cough, pain and shortness of breath.”

Treatment beyond disease progression2

Another Phase III study in lung cancer patients (LUX-Lung 5) also presented at ASCO met its primary endpoint by showing the advantage of continuing treatment with afatinib, in combination with chemotherapy, after the tumour started to grow on afatinib alone (treatment beyond progression). This Phase III study compared afatinib with paclitaxel (a chemotherapy) versus investigator’s choice of chemotherapy alone in patients with late-stage lung cancer after failure of several treatments, including chemotherapy, erlotinib or gefitinib, and afatinib alone.

Those patients who continued afatinib treatment with the addition of chemotherapy, after progressing on afatinib alone, had a further delay in tumour growth compared to the group who stopped afatinib treatment, and received chemotherapy only (tumour growth was delayed by 5.6 months and 2.8 months respectively). This corresponded to a 40% reduction in risk of disease progression. The most common adverse events in patients treated with afatinib and chemotherapy combination were diarrhea (often associated with EGFR inhibition), hair loss (alopecia) and weakness (asthenia – often associated with chemotherapy). See abstract #8019 for full details.

Professor Martin Schuler, M.D., West German Cancer Center at the University Hospital Essen, Germany, principal investigator commented: “These results indicate the potential of a new approach for these difficult-to-treat patients – the continuation of afatinib treatment with the addition of chemotherapy, even after previous EGFR TKI treatment has failed and tumours have started to grow again.”

Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim commented: “Lung cancer is not just one disease, and we are proud to be conducting research on afatinib in a variety of treatment settings that may ultimately expand treatment options for patients. The combined and individual overall survival results of LUX-Lung 3 and LUX-Lung 6, together with our existing previously reported quality of life and patient reported outcome data, contribute significantly to the robust body of evidence for the use of first-line afatinib in EGFR mutated lung cancer.”

Afatinib approved and investigational indications

Afatinib (GIOTRIF® / GILOTRIF®) is indicated for the treatment of distinct types of EGFR mutation-positive NSCLC. 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®. It is under regulatory review in other countries. Phase III trials in squamous head and neck cancer (HNSCC) and trials in other tumour types are ongoing.

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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1. Yang J, Sequist L et al. Overall survival (OS) In patients with advanced non-small cell lung cancer (NSCLC) harbouring common (Del19/L858R) Epidermal Growth Factor Receptor mutations (EGFR mut): pooled analysis of two large open-label phase III studies (LUX-Lung 3 [LL3] and LUX-Lung 6 [LL6] comparing afatinib with chemotherapy. Abstract #8004 presented at 2014 American Society of Clinical Oncology, 50th Annual Meeting, 30 May–3 June 2014, Chicago, IL, USA.

2. Schuler M, Chih-Hsin Yang J et al. Continuation of afatinib beyond progression: Results of a randomized, open-label, Phase III trial of afatinib plus paclitaxel versus investigator’s choice chemotherapy in patients with metastatic non-small-cell lung cancer (NSCLC) progressed on erlotinib/gefitinib and afatinib: LUX-Lung 5. Abstract #8019 presented at 2014 American Society of Clinical Oncology, 50th Annual Meeting, 30 May–3 June 2014, Chicago, IL, USA.


Boehringer Ingelheim

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Susanne Granold

55216 Ingelheim/Germany

Phone: +49 6132 – 77 93319

Fax: +49 6132 – 77 6601


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