FDA and EMA accept GIOTRIF® in squamous submission

FDA and EMA accept regulatory applications for Boehringer Ingelheim’s Giotrif® / Gilotrif® (afatinib) for treatment of advanced squamous cell carcinoma of the lung

  • Regulatory submissions are based on positive data from LUX-Lung 8 study that showed a significant delay in progression of lung cancer (progression-free survival, primary endpoint) and a significant improvement in overall survival for Giotrif (afatinib) compared to Tarceva (erlotinib)
  • LUX-Lung 8 is a large, prospective Phase III head-to-head trial which compared two EGFR-directed treatments in patients with squamous cell carcinoma (SCC) of the lung, progressing after treatment with first-line chemotherapy
  • Afatinib has also been granted orphan drug designation by the FDA – a status given to a product intended for the treatment of a rare disease or condition

Ingelheim, Germany, 25 August 2015 - Boehringer Ingelheim today announced that both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted filing applications for afatinib for the treatment of patients with advanced SCC of the lung progressing after treatment with first-line chemotherapy. Afatinib has also been granted orphan drug designation by the FDA – a status given to a product intended for the treatment of a rare disease or condition.

Dr. Jörg Barth, Corporate Senior Vice President, Therapy Area Head Oncology, Boehringer Ingelheim commented: “Working with the US and EU regulatory authorities marks the next stage in our journey to hopefully provide patients with a new, oral treatment for squamous cell carcinoma of the lung, a condition with an extremely poor prognosis and still limited treatment options. This is an encouraging prospect for Boehringer Ingelheim as we remain fully dedicated to improving and extending the lives of patients with different types of lung cancer.”

The submissions are based on data from the Phase III LUX-Lung 8 trial that compared Giotrif® / Gilotrif® (afatinib) to Tarceva® (erlotinib) in patients with advanced SCC of the lung progressing after treatment with first-line platinum-based chemotherapy.1 Data from the trial showed that treatment with afatinib resulted in superior progression-free survival (PFS, primary endpoint), reducing the risk of cancer progression by 19%, and superior overall survival (OS, key secondary endpoint), reducing the risk of death by 19% compared to erlotinib in this patient population.1

In the LUX-Lung 8 trial, an improvement in quality of life and control of cancer symptoms was observed with afatinib versus erlotinib.1 More patients had improved overall health-related quality-of-life with afatinib than with erlotinib (36% vs 28%).1 Significantly more patients had an improvement in cough with afatinib than with erlotinib (43% vs 35%).1 Differences in the proportion of patients with improved dyspnoea (51% vs 44%) and pain (40% vs 39%) were not significant for afatinib versus erlotinib.1 Afatinib significantly delayed time to deterioration of dyspnoea compared with erlotinib.1 Time to deterioration of both pain and cough was similar for afatinib versus erlotinib.1

The rate of severe adverse events was similar between the two treatment arms with differences observed in the incidence of certain side effects.1 A higher incidence of severe diarrhea and stomatitis (mouth sores) was observed with afatinib compared to erlotinib (grade 3 diarrhea: 10% vs. 2%; grade 3 stomatitis: 4% vs. 0%), while a higher incidence of severe rash/acne was reported with erlotinib compared to afatinib (grade 3 rash/acne: 10% vs. 6%).1

Non-small cell lung cancer (NSCLC) is the most common form of lung cancer comprising over 85% of lung cancer cases.2,3 Squamous cell lung cancer develops in the cells lining the airways and represents approximately 30% of NSCLC cases.4,5 SCC of the lung is associated with a poor prognosis and limited survival. The median overall survival after diagnosis of advanced SCC is around one year.6,7

Afatinib, an oral, once daily EGFR-directed therapy, is currently approved in more than 60 countries for the first-line treatment of specific types of EGFR mutation-positive NSCLC (under 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.8 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.9,10 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.9,10

Notes to Editors

About afatinib:  Giotrif 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

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.

Footnotes

* Afatinib is approved in a number of markets, including the EU, Japan, Taiwan and Canada under the brand name GIOTRIF® and in the US under the brand name GILOTRIF® for use in patients with specific 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 including squamous cell carcinoma of the lung.

Referências

  1. Soria et al. Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung (LUX-Lung 8): an open-label randomised controlled phase 3 trial. The Lancet Oncology 2015;DOI:10.1016/S1470-2045(15)00006-6
  2. 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.
  3. Howlader 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.
  4. 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.
  5. Bryant and Cerfolio. Differences in Epidemiology, Histology, and Survival Between Cigarette Smokers and Never-Smokers Who Develop Non-small Cell Lung Cancer. Chest 2007;132:185–192.
  6. Cancer Monthly. Lung Cancer (NSCLC). Available at: http://www.cancermonthly.com/cancer_basics/lung.asp. Accessed April 2015.
  7. Cetin et al. Survival by histologic subtype in stage IV non-small cell lung cancer based on data from the Surveillance, Epidemiology and End Results Program. Clin Epidemiol. 2011;3:139–148.
  8. Sequist 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.
  9. Wu 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.
  10. Yang et al. Afatinib versus cisplatin chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol 2015;DOI:10.1016/S1470-2045(14)71173-8