Head-to-head Phase III trial demonstrates superior progression-free survival for afatinib compared to erlotinib in patients with advanced squamous cell carcinoma of the lung

For Ex-US and Ex-UK Media Only

  •  LUX-Lung 8 trial met its primary endpoint of improving progression-free survival in patients treated with afatinib versus erlotinib after failure of first-line, platinum-based chemotherapy, reducing the risk of disease progression by 18%1
  • Overall rate of severe adverse events (> grade 3) was comparable between both therapies1
  • Limited treatment options currently exist for patients with squamous cell carcinoma of the lung, which represents approximately 30% of all non-small cell lung cancer cases2,3 with only about 15% of patients surviving for five years or longer4

Ingelheim, Germany/Ridgefield, CT/Bracknell, UK, 31 May 2015, Boehringer Ingelheim today announced overall survival (OS) results from the LUX-Lung 8 trial (NCT01523587) that directly compared the efficacy and safety of two EGFR-directed treatments, afatinib* and erlotinib, in patients with advanced squamous cell carcinoma (SCC) of the lung, progressing after treatment with first-line chemotherapy. Treatment with afatinib significantly reduced the risk of death by 19%, extending the survival of patients to a median of 7.9 months compared to 6.8 months on erlotinib.1 Significantly more patients treated with afatinib were still alive at one year compared to those treated with erlotinib (36.4% vs. 28.2%).1 The details of the OS analysis (abstract #8002 Oral presentation, Lung Cancer—Non-Small Cell Metastatic, Sunday May 31, 8:00-11.00, N Hall B1) will be presented today at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, USA.

The complete results from this study will be the basis for global regulatory submissions later this year. Afatinib is not approved for use in patients with SCC of the lung.

OS was the key secondary endpoint of this randomised Phase III head-to-head trial, and was analysed following positive results for the primary endpoint of progression-free survival (PFS) presented in 2014.2 The updated analysis of PFS confirmed a significant reduction in the risk of cancer progression by 19% in patients treated with afatinib compared with erlotinib.1 The delay in cancer progression seen with afatinib treatment was accompanied by improved control of cancer-related symptoms: a higher proportion of patients treated with afatinib reported improvement in cough (43.4 vs. 35.2%), shortness of breath (51.3 vs. 44.1%) and overall well-being/quality of life (35.7 vs. 28.3%) compared with erlotinib.1

LUX-Lung 8 clinical trial investigator Professor Jean Charles Soria, Head Drug Development Department, Gustave Roussy Cancer Centre, Paris, France commented: “Squamous cell lung cancer is a difficult-to-treat disease with extensive comorbidities, and patients would benefit from more treatment options. The results of LUX-Lung 8 are very encouraging because they illustrate the clinical relevance of targeting ErbB receptors in this disease. International guidelines recognise erlotinib as a second-line treatment option for squamous cell carcinoma of the lung, and improved outcomes demonstrated with afatinib suggest this treatment could offer additional benefits for this patient population.”

The rate of severe adverse events was similar between afatinib and erlotinib treatment arms (57.1 vs. 57.5%).1 A higher incidence of severe diarrhoea and stomatitis (mouth sores) was observed with afatinib compared to erlotinib (grade 3/4 diarrhoea: 9.9/0.5 vs. 2.3/0.3%, grade 3 stomatitis: 4.1 vs. 0.0%), while a higher incidence of severe rash/acne was reported with erlotinib compared to afatinib (grade 3 rash/acne: 10.4 vs. 5.9%).1 See abstract #8002 for full details.

Dr. Mehdi Shahidi, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim, commented: “Following the approval of afatinib in more than 50 countries for the treatment of specific types of EGFR mutation-positive lung cancer and positive overall survival data in patients with the most common EGFR mutation, we are proud to present another piece of evidence for afatinib showing it can prolong survival of patients with squamous cell lung cancer. At Boehringer Ingelheim we are committed to research and development in areas of high unmet need such as this. It is our goal that afatinib can become a new treatment option for these cancer patients in the near future.”

Non-small cell lung cancer (NSCLC) is the most common form of lung cancer comprising over 85% of lung cancer cases.3,4 SCC, a type of lung cancer which develops in the cells lining the airways, represents approximately 30% of NSCLC cases.5,6 Treatment options are limited and SCC of the lung is associated with a poor prognosis, with less than 5% of patients with advanced SCC surviving for five years or longer.7,8

LUX-Lung 8 was conducted across 23 countries and is the first prospective trial to compare two different tyrosine kinase inhibitors (TKIs) in patients with advanced SCC of the lung (n=795).

Afatinib is approved in more than 50 countries for the first-line treatment of distinct types of EGFR mutation-positive NSCLC (under the brand names: GIOTRIF® / GILOTRIF®). Approval of afatinib in this indication was based on the primary endpoint of PFS from the LUX-Lung 3 clinical trial where afatinib significantly delayed tumour growth when compared to standard chemotherapy.9 In addition, afatinib is the first treatment to show an OS benefit for patients with specific types of EGFR mutation-positive NSCLC compared to chemotherapy.10 A significant OS benefit was demonstrated independently in the LUX-Lung 3 and 6 trials for patients with the most common EGFR mutation (exon 19 deletions; del19) compared to chemotherapy.10

Notes to Editors

Intended audiences: 
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

About afatinib*:  Afatinib Backgrounder

About Boehringer Ingelheim in Oncology
 Boehringer Ingelheim in Oncology Backgrounder

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 146 affiliates and a total of more than 47,700 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.

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 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 per cent of its net sales.

For more information please visit www.boehringer-ingelheim.com

Footnotes

*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 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.

Referências

  1. Soria JC, et al. Afatinib (A) vs erlotinib (E) as second-line therapy of patients (pts) with advanced squamous cell carcinoma (SCC) of the lung following platinum-based chemotherapy: Overall survival (OS) analysis from the global phase III trial LUX-Lung 8 (LL8). Abstract #8002 presenred at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting, Chicago, USA. 29 May – 2 June 2015.
  2. Goss GD, et al., A randomized, open-label, phase III trial of afatinib (A) vs erlotinib (E) as second-line treatment of patients (pts) with advanced squamous cell carcinoma (SCC) of the lung following first-line platinum-based chemotherapy: LUX-Lung 8 (LL8). Abstract #1222O presented at the European Society for Medical Oncology (ESMO) 2014 Congress, Madrid, Spain. 26 – 30 September 2014.
  3. Tessen HW, et al. The treatment of lung cancer in German outpatient centres. Data from a clinical registry – TLK Registry. Onkologie. 2011;34 (Suppl.6)(Poster P533):153.
  4. Howlader, N. et al. SEER Cancer Statistics Review, 1975-2010, National Cancer Institute. Bethesda, MD, http://seer.cancer.gov/csr/1975_2010/, based on November 2012 SEER data submission, posted to the SEER web site, 2013.
  5. Atlas of Genetics and Cytogenetics in Oncology and Haematoogy. Lung: Non-small cell carcinoma. Available at http://atlasgeneticsoncology.org/Tumors/LungNonSmallCellID5141.html. Accessed April 2015.
  6. Bryant A and Cerfolio RJ. Differences in Epidemiology, Histology, and Survival Between Cigarette Smokers and Never-Smokers Who Develop Non-small Cell Lung Cancer. Chest 2007;132:185–192.
  7. Cancer Monthly. Lung Cancer (NSCLC). Available at: http://www.cancermonthly.com/cancer_basics/lung.asp. Accessed April 2015.
  8. Cetin et al. Survival by histologic subtype in stage IV nonsmall cell lung cancer based on data from the Surveillance, Epidemiology and End Results Program. Clin Epidemiol. 2011;3:139–148.
  9. 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.
  10. Wu Y-L, Zhou C, Hu C-P, et al. Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial. J Clin Oncol 2014;DOI:10.1016/S1470-2045(13)70604.