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Afatinib (Gilotrif) Superior to Gefitinib (Iressa) in Lung Cancer Trial

Head-to-head study compares second- and first-generation EGFR-targeted therapies

Results have been announced from the LUX-Lung 7 trial. Superiority in progression-free survival (PFS) and time to treatment failure was demonstrated with the second-generation epidermal growth factor receptor (EGFR)-directed therapy afatinib (Gilotrif, Boehringer Ingelheim) compared with first-generation gefitinib (Iressa, AstraZeneca) in the first-line treatment of patients with advanced non–small-cell lung cancer (NSCLC) with common EGFR mutations (del19 or L858R). The study results were presented at the 14th annual British Thoracic Society Oncology Group conference in Dublin, Ireland.

LUX-Lung 7 was the first global, head-to-head trial comparing second- and first-generation EGFR-directed therapies (afatinib and gefitinib, respectively) in patients with EGFR mutation-positive NSCLC who had not received prior treatment. The phase 2b study included 319 patients with advanced-stage NSCLC harboring common EGFR mutations (del19 or L858R). The trial’s coprimary endpoints were PFS by independent review, the time to treatment failure, and overall survival. Secondary endpoints included the objective tumor response rate, the disease control rate, tumor shrinkage, patient-reported outcomes, and safety.

The results showed that afatinib significantly reduced the risk of lung cancer progression by 27% compared with gefitinib. The improvement in PFS became more pronounced over time, with a significantly higher proportion of afatinib-treated patients alive and progression-free compared with gefitinib-treated patients at 18 months (27% vs. 15%, respectively) and 24 months (18% vs. 8%). In addition, patients treated with afatinib had a significantly longer time on treatment: the risk of treatment failure was reduced by 27% compared with gefitinib. Significantly more patients had an objective tumor response (a clinically meaningful decrease in tumor size) with afatinib compared with gefitinib (70% vs. 56%), with a median duration of response of 10.1 months and 8.4 months, respectively.

Treatment with afatinib and gefitinib was generally well tolerated, leading to equal treatment-related discontinuation rates in both arms (6.3%). The overall frequency of serious adverse events was similar for both therapies (44.4% for afatinib vs. 37.1% for gefitinib). The most common grade-3 or greater adverse events were diarrhea (12.5%) and rash/acne (9.4%) with afatinib, and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) increase (8.8%) and rash/acne (3.1%) with gefitinib. Drug-related interstitial lung disease was reported in four patients receiving gefitinib and in no patients receiving afatinib.

Source: Boehringer Ingelheim; January 27, 2016.

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