Boehringer Ingelheim announced that afatinib was superior to gefitinib in progression-free survival (PFS) and time to treatment failure in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) with common EGFR mutations (del19 or L858R). Study findings will be presented at the 14th Annual British Thoracic Oncology Group Conference.
LUX-Lung 7 trial was a Phase 2b, head-to-head trial, that compared second-generation EGFR-directed treatment afatinib vs. first-generation EGFR-directed treatment gefitinib. A total of 319 patients with advanced NSCLC were evaluated. The study’s co-primary endpoints were PFS by independent review, time to treatment failure, and overall survival (OS). Secondary endpoints included objective response rate, disease control rate, tumor shrinkage, patient-reported outcome, and safety.
Study data showed that treatment with afatinib significantly reduced the risk of lung cancer progression by 27% vs. gefitinib. At 18 months, a significantly higher proportion of patients were alive and progression-free with afatinib vs. gefitinib (27% vs. 15% ) as well as at 24 months (18% vs. 8%). Patients treated with afatinib also had a 27% lower risk of treatment failure vs. patients treated with gefitinib. The improvement in PFS with afatinib was consistent across most pre-defined subgroups, including gender, age, race, and EGFR mutation type.
Data regarding OS, the study’s third co-primary endpoint, are not yet available and will be announced in the future.
Afatinib (Gilotrif), an oral once-daily kinase inhibitor, is currently approved as first-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitutions as detected by an FDA-approved test. Gefitinib (Iressa; AstraZeneca) is currently approved as first-line treatment of metastatic NSCLC with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.
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