Phase 3 Study Update of Afatinib for EGFR Mutation-positive Advanced NSCLC

Boehringer Ingelheim announced new patient-reported health-related outcomes for its investigational oncology compound afatinib, including lung cancer-related symptoms and quality of life (QoL); these data are secondary endpoints of LUX-Lung 3, a Phase 3 trial in patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer (NSCLC).

The LUX-Lung 3 trial was a randomized, open-label, study comparing the oral once-daily therapy, afatinib, to a combination chemotherapy regimen as first-line treatment for patients with Stage IIIb or IV NSCLC harboring an EGFR mutation. The study randomly assigned 345 patients with EGFR mutation-positive advanced NSCLC to receive afatinib (n=230) or pemetrexed (Alimta; Lilly)/cisplatin (n=115).  As previously reported, the study met its primary endpoint of PFS with afatinib vs. chemotherapy (11.1 vs. 6.9 months, respectively) in patients with EGFR mutation-positive advanced NSCLC.

Three lung cancer symptoms – cough, dyspnea (shortness of breath), and pain – were analyzed using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire for lung cancer (QLQ-LC13). Results showed that a higher proportion of afatinib-treated patients had ≥10 point improvements in cough (67% vs. 60%; P=0.2444), dyspnea (64% vs. 50%; P=0.0103) and pain (59% vs. 48%; P=0.0513) compared with those treated with chemotherapy.  Patients treated with afatinib also reported a delay in the worsening (time to deterioration) of their lung cancer-related symptoms – cough (HR=0.6; P=0.0072) and dyspnea (HR=0.68; P=0.0145) – compared with those treated with chemotherapy. The time to deterioration of pain was not significant between the treatment arms (HR=0.82; P=0.1913). Mean symptom scores over time significantly favored afatinib over chemotherapy for cough and dyspnea.

Health-related QoL was measured using the EORTC QLQ-C30 questionnaire, which evaluated global health status/QoL (overall well-being) in addition to physical, cognitive, role, social and emotional functioning. Of these six measures, patients treated with afatinib experienced improvements in their global health-related quality of life and physical, cognitive and role functioning compared to chemotherapy (P<0.05).

Afatinib is an investigational, oral, once-daily irreversible ErbB Family Blocker that specifically inhibits epidermal growth factor receptor (EGFR or ErbB1), human epidermal receptor 2 (HER2 or ErbB2) and ErbB4.

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