First-line Afatinib Improves PFS vs Gefitinib in Advanced NSCLC

Afatinib significantly prolonged progression-free survival (PFS) compared with gefitinib as first-line treatment for patients with epidermal growth factor (EGFR) mutation-positive advanced non-small cell lung cancer (NSCLC), a study presented at the European Lung Cancer Conference (ELCC) 2016 has shown.¹

Afatinib is an irreversible ErbB family inhibitor indicated for the first-line treatment of patients with advanced EGFR-mutant NSCLC. Researchers sought to compare the efficacy and safety of first-line afatinib to that of gefitinib, a reversible EGFR kinase inhibitor.

For the international, open-label, phase 2b LUX-Lung 7 trial, researchers enrolled 319 patients with stage IIIb or stage IV NSCLC who harbor an EGFR mutation. Participants were randomly assigned 1:1 to receive afatinib 40 mg orally daily or gefitinib 250 mg orally daily until radiological disease progression or beyond if determined to be beneficial by the investigator.

Results showed afatinib significantly improved PFS compared with gefitinib (hazard ratio [HR], 0.73; 95% CI, 0.57-0.95; P = .017). Researchers also found that time to treatment failure was significantly longer with afatinib (HR, 0.73; 95% CI, 0.58-0.92; P = .007).

Objective response rate was 70% and 56% with afatinib and gefitinib, respectively (P = .008). Overall survival data were not yet mature and will be presented at a later date.

In terms of safety, the most frequently reported grade 3 or worse adverse events with afatinib were diarrhea (12.5%) and rash/acne (9.4%). The most common grade 3 or worse gefitinib-related adverse event was elevated alanine aminotransferase (8.2%).

Four patients in the gefitinib arm experienced drug-related interstitial disease compared with no patients in the afatinib arm. Approximately 6% of patients in each group discontinued therapy due to drug-induced toxicities.

Reference

1. Park K, Tan E, Zhang L, et al. LUX-Lung 7: A phase IIb, global, randomised, open-label trial of afatinib vs gefitinib as first-line treatment for patients (pts) with advanced non-small cell lung cancer (NSCLC) harbouring activating EGFR mutations. Poster presentation at: European Lung Cancer Conference 2016; April 13-16, 2016; Geneva, Switzerland.