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Afatinib (Gilotrif) Superior to Erlotinib (Tarceva) in Late-Stage Lung Cancer Trial

Progression-free survival improved in patients with squamous-cell carcinoma

New phase III data have demonstrated superior improvement in progression-free survival (PFS) with afatinib (Gilotrif, Boehringer Ingelheim) compared with erlotinib (Tarceva, Genentech/Astellas Oncology) in patients with advanced squamous-cell carcinoma (SCC) of the lung. The results were presented September 27 at the European Society for Medical Oncology (ESMO) 2014 congress in Madrid, Spain.

SCC represents approximately 30% of cases of non–small-cell lung cancer (NSCLC). Afatinib, a once-daily kinase inhibitor that irreversibly binds to and inhibits epidermal growth factor receptor (EGFR [ErbB1]), human epidermal growth factor receptor 2 (HER2 [ErbB2]), and ErbB4 receptor, is not approved for the treatment of SCC of the lung, and its safety and efficacy have not been established in this population.

The phase III, randomized, open-label LUX-Lung 8 trial was the largest prospective head-to-head study to evaluate the superiority of afatinib compared with erlotinib in patients with advanced SCC of the lung. A total of 795 patients with stage IIIB/IV SCC of the lung were randomly assigned to receive afatinib or erlotinib until disease progression. The planned primary analysis was based on 414 PFS events by independent review in the first 669 patients randomized (afatinib: 335, erlotinib: 334) while recruitment was ongoing.

In this study, afatinib significantly reduced the risk of disease progression by 18% compared with erlotinib and delayed tumor growth (PFS by independent review: 2.4 months vs. 1.9 months, respectively; hazard ratio = 0.82; P = 0.043).

Treatment with afatinib also showed improvement in the secondary endpoint of the disease control rate (i.e., the percentage of patients who achieved a complete response, a partial response, or stable disease) compared with erlotinib (45.7% vs. 36.8%, respectively; P = 0.020). The objective response rate (i.e., percentage of patients who achieved a partial or complete response to therapy) was 4.8% in the afatinib arm compared with 3.0% in the erlotinib arm (P = 0.233).

In addition to the efficacy measures, patient-reported outcomes were assessed. More patients reported an improvement in their global health status/quality of life (P = 0.026) and cough (P = 0.01) with afatinib copmared with erlotinib; no difference was observed for pain (P = 1.0) and dyspnea (P = 0.298) between the two groups. Moreover, there was no significant difference in the time to deterioration across these four measures.

The overall rate of severe (greater than grade 3) adverse events (AEs) was comparable between both therapies. The incidence of severe AEs was 50.2% for patients treated with afatinib compared with 49.1% for those treated with erlotinib. A higher incidence of severe diarrhea and stomatitis was observed in patients treated with afatinib compared with the erlotinib group (severe diarrhea: 9% vs. 2%, respectively; stomatitis: 3% vs. 0%), whereas there was a higher incidence of severe rash/acne in the erlotinib group compared with the afatinib group (9% vs. 6%).

Gilotrif (afatinib) is indicated for the first-line treatment of patients with NSCLC whose tumors have EGFR exon-19 deletions or exon-21 (L858R) substitution mutations, as detected by an FDA-approved test. The safety and efficacy of afatinib have not been established in patients whose tumors have other EGFR mutations.

Source: Boehringer Ingelheim; September 27, 2014.

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