Gilotrif May Improve Overall Survival in Lung Cancer

Boehringer Ingelheim announced new overall survival data from two Phase 3 trials, LUX-Lung 3 and LUX-Lung 6 for Gilotrif (afatinib) 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. GILOTRIF is an oral, once-daily kinase inhibitor that is designed to irreversibly bind and inhibit the EGFR (ErbB1), HER2 (ErbB2) and ErbB4 receptors.

The LUX-Lung 3 trial compared afatinib with chemotherapy (pemetrexed/cisplatin) as a first-line treatment in patients with advanced NSCLC with EGFR mutations. The LUX-Lung 6 clinical trial evaluated afatinib vs. chemotherapy (gemcitabine/cisplatin) as a first-line treatment for Asian patients with advanced NSCLC with EGFR mutations.

In the pooled analysis from both trials, 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% (HR=0.81, P=0.037). The most pronounced reduction in risk of death was 41% (HR=0.59, CI 0.45, 0.77) in patients whose tumors have the exon 19 deletion mutation; for patients with the exon 21 mutation there was no impact on overall survival (HR=1.25, CI 0.92, 1.71).

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Boehringer Ingelheim also announced results from LUX-Lung 5, a Phase 3 study in NSCLC patients. This study compared afatinib and paclitaxel vs. investigator's choice of chemotherapy alone in patients with late-stage NSCLC whose disease has progressed after afatinib alone and have also failed several treatments, including chemotherapy, erlotinib or gefitinib. The primary endpoint of improvement in progression-free survival when continuing treatment with afatinib in combination with chemotherapy after the tumor started to grow on afatinib alone was met.

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 respectively, P=0.003). This corresponded to a 40% reduction in risk of disease progression (HR=0.60).

Gilotrif is already approved for the first-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 substitution mutations as detected by an FDA-approved test.

Boehringer Ingelheim plans to announce additional safety and efficacy results at the American Society of Clinical Oncology (ASCO) Annual Meeting.

For more information call (800) 542-6257 or visit Boehringer-Ingelheim.com.

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