BOEHRINGER-INGELHEIM

Boehringer Ingelheim today announced results from the LUX-Lung 7 trial that directly compared the efficacy and safety of second-generation EGFR-directed therapy afatinib* (Giotrif^® ) and first-generation gefitinib (Iressa^® ), in the first-line treatment of patients with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC). The trial investigated overall survival (OS) as a primary endpoint and a reduction in the risk of death (14%) was observed for patients treated with afatinib versus gefitinib. The median survival of patients treated with afatinib was 27.9 months compared to 24.5 months for those receiving gefitinib, without reaching significance. The OS outcomes observed with afatinib were consistent across common EGFR mutation types. Details of the analysis will be presented today at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen, Denmark, 7 – 11 October (abstract #LBA43 - Oral presentation, NSCLC, metastatic 1, Sunday 9 October, 11:45 - 12:00 CEST).

LUX-Lung 7 co-lead investigator Professor Luis Paz-Ares, Hospital Universitario 12 de Octubre, Madrid, Spain commented: “In the LUX-Lung 7 trial we observed a reduction in the risk of death with median overall survival being 3.4 months longer for afatinib versus gefitinib, although this was not of sufficient magnitude to reach statistical significance. This, combined with the significantly improved progression-free survival and time to treatment failure demonstrated with afatinib in the trial, provides clinically relevant insight into the difference between the two treatments.”

Updated results also confirmed the primary analysis that showed the global Phase IIb LUX-Lung 7 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). Results from the primary analysis, presented in 2015, showed that afatinib significantly reduced the risk of lung cancer progression and the risk of treatment failure both by 27% versus gefitinib. The improvement in PFS became more pronounced over time. After two years of treatment, more than twice as many patients on afatinib were alive and progression-free than those on gefitinib (after 18 months; 27% vs 15% and after 24 months; 18% vs 8%). Additionally, significantly more patients experienced an objective response (ORR; a clinically meaningful decrease in tumour size) with afatinib when compared to gefitinib.

Both afatinib and gefitinib demonstrated similar improvements in patient-reported outcome measures in the LUX-Lung 7 trial with no significant differences in health-related quality of life with afatinib compared to gefitinib treatment. Treatment with both afatinib and gefitinib was generally tolerable, leading to an equal rate of treatment-related discontinuation in both arms (6%). Adverse events (AEs) observed in the trial were consistent with the known safety profiles of both treatments. Dose modification of afatinib, available for patients who met a set criteria to better manage treatment-related AEs, showed no apparent impact on efficacy. As gefitinib is only available in one dose formulation, no dose reduction was administered.

“It is our goal to add to the clinical evidence around the use of EGFR-directed therapies, allowing physicians and patients to make informed treatment decisions based on individual needs,” said Mehdi Shahidi, M.D., Vice President and Global Head of Medicine, Oncology, Boehringer Ingelheim. “We believe that the totality of the results of the LUX-Lung 7 trial data helps differentiate second-generation afatinib from first-generation therapies for these patients, adding to the growing body of evidence that reinforces its distinct treatment benefits.”

Afatinib* is approved in over 70 countries for the first-line treatment of EGFR mutation-positive NSCLC. 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 (del19) compared to chemotherapy. Afatinib is also approved in the EU, US and other markets 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. Approval of afatinib in this indication is based on results of the LUX-Lung 8 study, which showed significantly improved overall survival and progression-free survival compared to erlotinib (Tarceva^® ) in patients with SqCC of the lung.

*Afatinib is approved in a number of markets, including the EU, Japan, Taiwan and Canada under the brand name Giotrif ^® , in the US under the brand name Gilotrif ^® and in India under the brand name Xovoltib ^® for use in patients with distinct types of EGFR mutation-positive NSCLC. Afatinib is also approved in the EU, US and other markets for the treatment of patients with advanced SqCC of the lung whose disease has progressed (on or) after treatment with platinum-based chemotherapy. Afatinib is under regulatory review by health authorities in other countries worldwide. Registration conditions differ internationally, please refer to locally approved prescribing information.

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/press-release/overall-survival-data-lux-lung-7-head-head-trial

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