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Boehringer Ingelheim Presents Progression-Free Survival Data for Investigational Afatinib and Nintedanib in Advanced NSCLC
Date:5/15/2013

stigational compounds in our growing oncology pipeline."

The LUX-Lung 6 Clinical Trial of Afatinib
LUX-Lung 6 (Efficacy) Abstract: #8016
Poster Discussion: Sunday, June 2, 11:30 AM-12:30 PM, poster board #5

The LUX-Lung 6 trial is the largest randomized, open-label Phase III trial conducted to date in the EGFR mutation-positive advanced (stage IIIb or IV) NSCLC patient population. The trial evaluated afatinib compared to standard chemotherapy (gemcitabine and cisplatin), as a first-line treatment in 364 Asian patients.1

The trial met its primary endpoint of PFS as assessed by independent central review; within the general study population, patients treated with afatinib (n=242) lived for a median of 11.0 months before their tumor started to grow again versus 5.6 months for patients treated with chemotherapy (n=122) (HR=0.28, p<0.0001).1 The PFS findings were consistent across EGFR mutation sub-groups.1 Secondary efficacy endpoints included objective response rate (ORR: proportion of patients with tumor size reduction of a predefined amount and for a minimum time period3) and disease control rate (DCR: proportion of patients who have achieved complete response, partial response and stable disease4). Patients treated with afatinib experienced significantly higher ORR (66.9% versus 23.0%, p<0.0001) and DCR (92.6% versus 76.2%, p<0.0001) compared to patients treated with chemotherapy.1

The most common greater than or equal to grade 3 drug-related adverse events observed in the afatinib treatment arm were rash/acne (14.6%), diarrhea (5.4%) and stomatitis/mucositis (5.4%).1 The most common greater than or equal to grade 3 drug-related adverse events observed in the gemcitabine/cisplatin treatment arm were neutropenia (17.7%), vomiting (15.9%) and leukopenia (13.3%).1 Overall, 5.9 percent of patients treated
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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