New data shows survival benefits of Gilotrif for NSCLC - Boehringer
Boehringer Ingelheim has announced new overall survival data of two Phase III clinical trials (LUX-Lung 3 and LUX-Lung 6) in patients with advanced Non-Small Cell Lung Cancer (NSCLC) whose tumors have the most common epidermal growth factor receptor (EGFR) mutation (exon 19 deletion) treated with Gilotrif (afatinib). In the pooled analysis from two of the largest trials in this patient population, afatinib prolonged survival of lung cancer patients whose tumors have common EGFR mutations compared with standard chemotherapy by a median of 3 months (27.3 to 24.3 months) and significantly reduced the risk of death by 19%. The most pronounced reduction in risk of death was 41% in patients whose tumors have the most common EGFR mutation (exon 19 deletion of the EGFR gene).
Results from another Phase III study in NSCLC patients (LUX-Lung 5) met its primary endpoint by showing an improvement in progression-free survival (PFS) when continuing treatment with afatinib in combination with chemotherapy after the tumor started to grow on afatinib alone (treatment beyond progression). Those patients who continued afatinib treatment, with the addition of chemotherapy, after progressing on afatinib alone, had a further delay in tumor growth compared to the group who stopped afatinib treatment and received chemotherapy only (tumor growth was delayed by 5.6 months and 2.8 months). This corresponded to a 40% reduction in risk of disease progression. Data will be presented or published at ASCO.
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