Value through Innovation21 December 2014
15 July 2013

U.S. FDA approves Gilotrif™ (afatinib)* as first-line treatment for lung cancer patients with EGFR mutations

• Patients with EGFR positive lung cancer now have a new treatment option in the U. S. – Gilotrif™ – which has shown superior efficacy versus the standard of care chemotherapy1
• Approval supported by LUX-Lung 3, the largest global Phase III trial in patients with EGFR mutation positive lung cancer
• First approval for afatinib, the frontrunner from Boehringer Ingelheim’s new oncology pipeline

Ingelheim, Germany, 15 July 2013 – Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved afatinib tablets under the U.S. brand name GILOTRIFTM for oral use, as a new first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.2

Lung cancer is the biggest cancer killer in the world with incidence rates higher in men than in women, it accounts for 1.6 million new cancer cases annually.3 However, lung cancer isn’t just one disease; research has shown there are many different types requiring specific treatment approaches. One distinct subtype of lung cancer is defined by mutations in EGFR (a member of the ErbB Family of receptors). These are patients that in clinical trials have been shown to benefit most from afatinib treatment.

Prof Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim

Prof Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim

"We are delighted to announce the first approval of afatinib, offering a new personalised treatment approach for patients with EGFR mutation positive NSCLC," said Prof Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "It marks the first of what we hope will be many products to emerge from our oncology research and development programme, and underscores our continued commitment to translating innovative science into new treatment options for patients."

In the U.S., afatinib received orphan drug status and was assessed under the FDA’s priority review programme, which provides an expedited review for drugs that may provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products. Boehringer Ingelheim strives to make afatinib available to patients around the world. Afatinib has been submitted to the EMA and regulatory authorities in Asia and other countries for treatment of EGFR mutation positive locally advanced and metastatic NSCLC.

The approval of afatinib in the U.S. is based on data from the pivotal LUX-Lung 3 trial, comparing afatinib to chemotherapy with pemetrexed/cisplatin. Data from LUX-Lung 3 has shown that patients taking afatinib as a first-line treatment lived for almost one year without their tumour growing again (median progression-free survival (PFS) of 11.1 months) versus just over half a year (PFS of 6.9 months) for those treated with pemetrexed/cisplatin. In addition, NSCLC patients with tumours harbouring the two most common EGFR mutations (Del19 or L858R) taking afatinib lived for well over a year without tumour progression (PFS of 13.6 months) versus just over half a year (PFS of 6.9 months) for those in the comparator arm.1

In addition, patients taking afatinib also experienced an improvement in lung cancer symptoms and a better quality of life compared to those receiving standard chemotherapy treatment.

The most common grade 3 drug-related adverse events observed in the afatinib treatment arm were diarrhoea (14%), rash (16%), and inflammation of the nail bed (paronychia) (11%). The most common drug-related grade 3 adverse events observed in the chemotherapy arm (pemetrexed/cisplatin) were neutropenia (15%), fatigue (13%), and leucopenia (8%). There was a low discontinuation rate associated with treatment-related adverse events in the trial (8% discontinuation rate for afatinib; 12% for chemotherapy). One percent of patients in the afatinib arm discontinued due to drug-related diarrhoea.1

Notes to Editors

About Afatinib
Afatinib is approved by the U.S. FDA for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.2

Afatinib is an irreversible ErbB Family Blocker which irreversibly blocks EGFR (ErbB1) as well as the other relevant members of the ErbB Family that are known to play a critical role in the growth and spread of the most pervasive cancers and cancers associated with high mortality. The covalent and, therefore, irreversible binding of afatinib is unlike other compounds which are reversible in that it provides a sustained, selective, and complete ErbB Family Blockade, and therefore may lead to a distinct therapeutic benefit.4,5

Afatinib is currently in Phase III clinical development in NSCLC and head & neck cancer.

About Lung Cancer
Lung cancer is the most common and most deadly form of cancer in the world, it accounts for 1.6 million new cancer cases annually.3 Because of its poor prognosis, 1.38 million deaths each year are attributable to lung cancer.3 Overall, lung cancer is the cause of 18% of all cancer deaths.3 Approximately 13% of all new cases of cancer are lung cancers6 and smoking is attributed as the main cause.

Early testing for tumour EGFR mutation status is critical in improving patient outcomes. Between 10-15% of Caucasian and 40% of Asian NSCLC patients have tumours harbouring EGFR mutations, which in 90% of cases are one of the two most common EGFR mutations (Del19 or L858R).7

About Boehringer Ingelheim in Oncology
Building on scientific expertise and excellence in the fields of pulmonary and cardiovascular medicine, metabolic disease, neurology, virology and immunology, Boehringer Ingelheim has embarked on a major research programme to develop innovative cancer drugs. Working in close collaboration with the international scientific community and a number of the world’s leading cancer centres, Boehringer Ingelheim’s commitment to oncology is underpinned by using advances in science to develop a range of targeted therapies for various solid tumours and haematological cancers.

The current focus of research includes compounds in three areas: angiogenesis inhibition, signal transduction inhibition and cell-cycle kinase inhibition. Volasertibi is the most advanced pipeline compound for haematological cancers. The pipeline for haematological cancers also includes two new biological entities (NBEs) using an immunotherapeutic approach: BI 836858 is an anti-CD33 antibody targeting AML and BI 836826 is an anti-CD37 antibody targeting chronic lymphocytic leukaemia (CLL) and B-cell non-Hodgkin's lymphoma (B-NHL).

Boehringer Ingelheim’s oncology pipeline is evolving and demonstrates the company’s continued commitment to advance the disease area.

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

Social responsibility is a central element of Boehringer Ingelheim's culture. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavours.

In 2012, Boehringer Ingelheim achieved net sales of about 14.7 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.

For more information please visit: www.boehringer-ingelheim.com and www.newshome.com

* In the U.S., afatinib is approved under the U.S. brand name GILOTRIF™. Afatinib is under regulatory review by EMA and health authorities in Asia and other countries.

i Volasertib is an investigational compound and is not yet approved. It’s safety and efficacy have not yet been fully established.

References

1 Sequist L, Yang J, Yamamoto N, et al. Phase III Study of Afatinib or Cisplatin Plus Pemetrexed in Patients With Metastatic Lung Adenocarcinoma With Epidermal Growth Factor Receptor Mutations. J Clin Oncol 2013;DOI: 10.1200/JCO.2012.44.2806
2 U.S. GILOTRIF™ Prescribing Information
3 Ferlay J, Shin HR, Bray F, et al. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer 2010;127:2893-917.
4 Solca F, Dahl G, Zoephel A, et al. Target binding properties and cellular activity of afatinib (BIBW 2992), an irreversible ErbB family blocker. J Pharmacol Exp Ther 2012;343:342-50.
5 Reid A, Vidal L, Shaw H, do Bono J. Dual inhibition of ErbB1 (EGFR/HER1) and ErbB2 (HER2/neu). Eur J Cancer 2007;43:481-9.
6 Cancer Research UK. UK lung cancer incidence. CancerStats – Key Facts 2009. [Online] Available at: http://info.cancerresearchuk.org/cancerstats/types/lung/incidence/ [Last Accessed July 2013].
7 Jang, T.W. et al. 2009. EGFR and KRAS Mutations in Patients With Adenocarcinoma of the Lung. The Korean Journal of Internal Medicine, March; 24(1), pp.48–54.

Media contact

  • Malin
    Boehringer Ingelheim

    Media & PR
    Dr Reinhard Malin
    Binger Strasse 173
    55216 Ingelheim am Rhein

    GERMANY