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).