Results from Boehringer Ingelheim's afatinib Phase III lung cancer trial

Highly anticipated results from LUX-Lung 3, the pivotal Phase III lung cancer trial investigating Boehringer Ingelheim's front running oncology investigational compound, the ErbB Family Blocker afatinib, in patients with EGFR mutations, will be presented at the 48^th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from 1 - 5 June 2012. LUX-Lung 3, which compares afatinib to standard platinum based chemotherapy, is the largest Phase III trial in first-line EGFR mutation positive, advanced, metastatic non-small cell lung cancer (NSCLC) patients. LUX-Lung 3 is also the first study using pemetrexed/cisplatin as a comparator.

Comprehensive data from 16 abstracts in both late and early Phase clinical trials will be presented at ASCO demonstrating Boehringer Ingelheim´s ongoing commitment to delivering innovative cancer therapies to patients. The presentation of the LUX-Lung 3 trial in particular will shed light on the results for afatinib as a first-line treatment for those NSCLC patients who harbour a mutation in their Epidermal Growth Factor Receptor genes (EGFR M+), a distinct or specific patient population who is known to respond differently to targeted therapies (e.g. Tyrosine Kinase Inhibitors).

The LUX-Lung 3 results will be presented as a late breaking oral presentation on Monday 4 June at 15:00 Central Daylight Time / 22:00 Central European Time.

"We are excited to present the results of this pivotal Phase III trial, the largest and most robust of its kind," said Prof. Dr. Gerd Stehle, VP and Therapeutic Area Head of Oncology at Boehringer Ingelheim. "As we are continuously advancing the development of our irreversible ErbB Family Blocker, we have initiated two additional trials, LUX-Lung 7 and 8, to further assess the potential benefit of afatinib in patients with NSCLC. These are all important steps in establishing personalised care for lung cancer patients and it highlights the importance of early assessment of EGFR mutation status."

The two newly initiated trials are currently recruiting patients. LUX-Lung 7 is a Phase IIb trial evaluating afatinib head-to-head versus gefitinib as a first-line treatment in EGFR mutation positive NSCLC patients. LUX-Lung 8 is a Phase III trial evaluating afatinib head-to-head versus erlotinib in second-line treatment of squamous cell carcinoma of the lung. Genome research in oncology in recent years has revealed that NSCLC patients with EGFR mutations need to be considered a distinct group of NSCLC patients, who require a different treatment approach for more effective outcomes.