publication date: Oct. 30, 2014

Gilotrif Increases PFS Compared to Erlotinib In LUX-Lung 8 Phase III Head-to-Head Trial


Phase III data from the LUX-Lung 8 head-to-head trial, evaluating Gilotrif versus erlotinib in patients with advanced squamous cell carcinoma of the lung, demonstrated superior improvement in progression-free survival with Gilotrif.

The trial demonstrated that Gilotrif (afatinib) significantly reduced the risk of disease progression by 18 percent when compared to erlotinib and delayed tumor growth (PFS by independent review: 2.4 vs. 1.9 months; HR=0.82; p=0.043). Overall survival data are not yet mature.

Treatment with Gilotrif showed improvement in the secondary endpoint of disease control rate compared to erlotinib, 45.7 vs. 36.8 percent, respectively (p=0.020). Objective response rate was 4.8 percent in the Gilotrif arm compared to 3.0 percent in the erlotinib arm (p=0.233).

More patients reported an improvement in their global health status or quality of life (p=0.026) and cough (p=0.01) with Gilotrif versus erlotinib. No difference was observed with pain (p=1.0) and dyspnea (p=0.298) between groups. There was no significant difference in the time to deterioration across these four measures.

The trial results were presented at the ESMO 2014 Congress. Gilotrif, sponsored by Boehringer Ingelheim, is a once-daily kinase inhibitor that irreversibly binds and inhibits ErbB1, ErbB2 and ErbB4 receptors, and is not approved for SCC of the lung. Its safety and efficacy have not been established in this population.

LUX-Lung 8 is the largest prospective head-to-head trial to evaluate the superiority of Gilotrif versus erlotinib … Continue reading CCL Oct – Lung Cancer

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