Boehringer Ingelheim: EU grants marketing authorisation for Giotrif® for the treatment of patients with advanced squamous cell carcinoma (SqCC) of the lung

• Approval provides a new oral treatment option for patients with the second largest sub-type of non-small cell lung cancer (NSCLC), representing approximately 20-30% of NSCLC cases.^1,2
• Approval of Giotrif® is based on results of the LUX-Lung 8 study, which showed significantly improved overall survival and progression-free survival compared to Tarceva® (erlotinib) in patients with squamous cell carcinoma of the lung³
• Afatinib is already approved in more than 60 countries for the treatment of patients with EGFR mutation-positive NSCLC*

Ingelheim, Germany, 08-Apr-2016 — /EuropaWire/ — Boehringer Ingelheim today announced that the European Commission (EC) has granted marketing authorisation for Giotrif® (afatinib) for the treatment of patients with advanced squamous cell carcinoma (SqCC) of the lung whose disease has progressed on or after treatment with platinum-based chemotherapy. Afatinib is already approved for the treatment of patients with EGFR mutation-positive non-small cell lung cancer (NSCLC).*

Dr. Mehdi Shahidi, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim commented: “Whilst there have been some recent and significant advances in the treatment of squamous cell carcinoma of the lung, the intravenous administration and frequent visits to the hospital can be a challenge for patients often debilitated by this disease. In this context and supported by robust evidence from a Global head-to-head Phase III study, we are pleased to offer an effective oral treatment option for patients suffering from this type of lung cancer to the European market.”

SqCC of the lung is associated with a poor prognosis, limited survival and symptoms like cough and dyspnoea. The median overall survival (OS) after diagnosis of advanced SqCC is around one year.^4,5

The marketing authorisation in Europe is valid for 28 countries within the EU. The EU regulatory submission was based on results of the head-to-head LUX-Lung 8 trial in patients with SqCC of the lung whose tumours progressed on or after first-line chemotherapy. Afatinib, compared to erlotinib, demonstrated:³

• Significant delay in progression of lung cancer (PFS, progression-free survival, primary endpoint), reducing the risk of cancer progression by 19%
• Significant improvement in overall survival (OS, key secondary endpoint), reducing the risk of death by 19%
• Significantly improved disease control rate (51% vs 40%; P=0.002)
• An improvement in quality of life and control of cancer symptoms

The rate of severe adverse events was similar between the two treatment arms with differences observed in the incidence of certain side effects: a higher incidence of severe diarrhoea and stomatitis (mouth sores) was observed with afatinib compared to erlotinib (grade 3 diarrhoea: 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%).³

LUX-Lung 8 (NCT01523587) is part of the afatinib LUX-Lung programme – the largest collection of clinical trials of any EGFR tyrosine kinase inhibitor (TKI), with over 3,760 patients across eight studies conducted across the world. The comprehensive LUX-Lung programme includes two pivotal studies in the first-line setting for EGFR mutation-positive patients, LUX-Lung 3 and 6 which compared afatinib to chemotherapy regimens. In addition, the programme included two head-to-head studies (LUX-Lung 7 and 8) of afatinib versus first-generation EGFR TKIs. The LUX-Lung programme has involved over 680 sites in 40 countries, reflecting the strong partnership between Boehringer Ingelheim and the lung cancer specialist community.

Afatinib is already approved in over 60 countries for the first-line treatment of EGFR mutation-positive NSCLC*, and recent results from the LUX-Lung 7 trial positively underscore the benefits of afatinib versus gefitinib, another first-generation EGFR targeting agent in this indication.⁶ Results of this global Phase IIb head-to-head trial demonstrated afatinib was superior in reducing the risk of lung cancer progression and the risk of treatment failure both by 27% compared to gefitinib.⁶

For more information about the LUX-Lung 8 trial, please see Professor Jean-Charles Soria’s publication in The Lancet Oncology

*Afatinib is approved in the EU under the brand name GIOTRIF® for the first-line treatment of TKI naïve adult patients with advanced EGFR mutation-positive NSCLC. In April 2016 afatinib was approved by the European regulatory authority as a second-line treatment for SqCC of the lung. Registration conditions differ internationally, please refer to locally approved prescribing information.

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
http://newscentre.boehringer-ingelheim.com/education_hub1/oncology/infographic/AFATINIB_IRREVERSIBLE_ERBB_FAMILY_BLOCKER.html

About Boehringer Ingelheim in Oncology
http://newscentre.boehringer-ingelheim.com/education_hub1/oncology/backgrounder/bi_oncology_backgrounder.html

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.

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References
1. Travis WD. Clin. Chest Med. 2011;32(4):669–692.
2. Hall PE et al. Future Oncol. 2015;11(15):2175-91.
3. 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.
4. Cancer Monthly. Lung Cancer (NSCLC). Available at: http://www.cancermonthly.com/cancer_basics/lung.asp. Accessed April 2016.
5. 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.
6. Park K, et al. Afatinib versus gefitinib as first-line treatment for patients with advanced non-small cell lung cancer harboring activating EGFR mutations: results of the global, randomized, open-label, Phase IIb trial LUX-Lung 7. LBA2, oral presentation at the ESMO Asia 2015 Congress in Singapore, 18-21 December 2015.

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Dr. Mehdi Shahidi, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim