BOEHRINGER-INGELHEIM

Boehringer Ingelheim’s Giotrif ^® / Gilotrif ^® (afatinib) demonstrated superiority to Iressa ^® (gefitinib) in reducing the risk of disease progression and treatment failure in first-line treatment of patients with EGFR mutation-positive advanced non-small cell lung cancer

• Results of global Phase IIb LUX-Lung 7 trial demonstrate afatinib superior in reducing the risk of lung cancer progression and the risk of treatment failure both by 27% compared to gefitinib
• More patients on afatinib were free of cancer growth 18 and 24 months after the start of treatment (27% vs 15% and 18% vs 8%, respectively)
• The overall frequency of patients experiencing serious adverse events and discontinuing treatment due to adverse events was similar in both arms

Boehringer Ingelheim announced today the results of the LUX-Lung 7 trial. Superiority in progression-free survival and time to treatment failure was demonstrated with second-generation EGFR-directed therapy afatinib, versus first-generation gefitinib in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) with common EGFR mutations (del19 or L858R). The Phase IIb trial met two of its co-primary endpoints of progression-free survival (PFS) by independent review and time to treatment failure (a measure of time between start and discontinuation of treatment for any reason). The LUX-Lung 7 trial results will be presented today at the 14th Annual British Thoracic Oncology Group (BTOG) Conference in Dublin, Ireland. Data for the third co-primary endpoint, overall survival (OS), are not yet mature and will be presented in the future.

Results from the LUX-Lung 7 trial showed that afatinib significantly reduced the risk of lung cancer progression by 27% versus gefitinib. The improvement in PFS became more pronounced over time, with a significantly higher proportion of patients alive and progression-free at 18 months (27% vs 15%) and 24 months (18% vs 8%), showing a greater long-term benefit to using afatinib versus gefitinib. In addition to superior PFS, patients on afatinib had a significantly longer time on treatment: risk of treatment failure reduced by 27%, versus gefitinib. Significantly more patients had an objective tumour response (a clinically meaningful decrease in tumour size) with afatinib when compared to gefitinib (70% vs 56%), with a median duration of response of 10.1 months and 8.4 months, respectively. The improvement in PFS with afatinib was consistent across most pre-defined clinical subgroups, including gender, age, race and EGFR mutation type.

LUX-Lung 7 lead investigator Professor Keunchil Park, director of Innovative Cancer Medicine Institute (ICMI) at Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea commented, “LUX-Lung 7 is the first global trial directly comparing two EGFR-directed therapies and the results demonstrate the benefits of second-generation inhibitor afatinib, compared to first-generation drug, gefitinib, in first-line therapy. These results provide important guidance on the choice of first-line treatment for patients with EGFR mutation-positive lung cancer.”

Adverse events (AEs) observed in the LUX-Lung 7 trial were consistent with the known safety profiles of both treatments. Treatment with both afatinib and gefitinib was generally tolerable, leading to an equally low rate of treatment-related discontinuation in both arms (6.3%). The overall frequency of serious AEs was similar for both (afatinib: 44.4% vs gefitinib: 37.1%); the most common grade ≥3 related AEs with afatinib were: diarrhoea (12.5%) and rash/acne (9.4%), and with gefitinib: aspartate aminotransferase (AST)/alanine aminotransferase (ALT) increase (8.8%) and rash/acne (3.1%). Drug-related interstitial lung disease was reported for four patients on gefitinib and no patients on afatinib.

“LUX-Lung 7 is the second positive head-to-head trial of afatinib versus first-generation EGFR TKIs in lung cancer, showing that first- and second-generation EGFR targeted agents are not the same,” said Dr Mehdi Shahidi, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim. “Interestingly, the progression-free survival difference observed in the LUX-Lung 7 trial became more prominent over time so that by 24 months the rate of patients who were free of cancer growth was more than doubled with afatinib.”

About the LUX-Lung 7 trial

LUX-Lung 7 is the first global, head-to-head trial comparing second- and first-generation EGFR-directed therapies (afatinib and gefitinib respectively) for patients with EGFR mutation-positive NSCLC who received no prior treatment. The Phase IIb trial included 319 patients with advanced stage NSCLC harbouring common EGFR mutations (del19 or L858R). The trial’s co-primary endpoints were PFS by independent review, time to treatment failure and OS; and the secondary endpoints included objective response rate, disease control rate, tumour shrinkage, patient-reported outcomes and safety.

Results: compared to gefitinib, afatinib significantly improved:

• PFS (HR=0.73; 95% CI, 0.57‒0.95; p=0.0165; median: 11.0 months [afatinib] versus 10.9 months [gefitinib])
• Time to Treatment Failure (HR=0.73; 95% CI, 0.58‒0.92; p=0.0073; median: 13.7 months [afatinib] versus 11.5 months [gefitinib])
• Objective Response Rate (70% vs 56%, p=0.0083)

Afatinib is approved in more than 60 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. In addition, afatinib is the first treatment to have shown an OS benefit for patients with specific types of EGFR mutation-positive NSCLC compared to chemotherapy. 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.

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.

For references and notes to editors, please visit:
http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2016/27_january_2016_oncology.html

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