Overall Survival For Advanced EGFR-mutated NSCLC Comparable With Afatinib, Gefitinib

LUX-Lung 7 trial results show longer progression-free survival but not overall survival for afatinib versus gefitinib

medwireNews: Updated overall survival (OS) analysis of the LUX-Lung 7 trial has failed to demonstrate a significant benefit for afatinib over gefitinib in patients with treatment-naïve stage IIIb/IV non-small-cell lung cancer (NSCLC) positive for an epidermal growth factor receptor (EGFR) mutation.

At the preplanned analysis, after a median of 42.6 months, OS was a median of 27.9 months with afatinib versus 24.5 months with gefitinib, giving a nonsignificant hazard ratio (HR) of 0.86, say Luis Paz-Ares, from Hospital Universitario Doce de Octubre in Madrid, Spain, and co-investigators.

Nor was there any significant increase in OS with afatinib in preplanned subgroups, such as gender, baseline ECOG score, the presence or absence of brain metastases at study entry, the type of EGFR mutation present or smoking history, they report in the Annals of Oncology.

Nevertheless, the current findings confirm an earlier report of improved progression-free survival with afatinib versus gefitinib, at 11.0 versus 10.9 months and an HR of 0.74, as well as a longer time to treatment failure (13.7 vs 11.5 months, HR=0.75) and a higher objective response rate (72.5 vs 56.0%, odds ratio=2.12).

The researchers add that the safety profiles of the two agents were “virtually unchanged” since the primary analysis, with treatment-related grade 3 or more severe adverse events occurring in 31.3% of patients given afatinib and 19.5% of gefitinib-treated patients.

Afatinib was most commonly associated with diarrhoea, rash/acne and fatigue, while gefitinib was linked to elevated liver enzymes, rash/acne and interstitial lung disease. Both treatments had a low rate of discontinuations linked to drug-related adverse events, at 6.3% each.

Discussing their OS findings further, Luis Paz-Ares et al note that the LUX-Lung 7 study was “not powered” for this endpoint and that, at time of writing, 29% of patients were still alive. “[A] final OS analysis is planned on study completion”, they say.

And the authors conclude: “[A]lthough LUX-Lung 7 was an exploratory phase IIb trial, we believe that the size of the trial (with 319 randomised patients it was as large as many phase III trials in the same setting) and the totality of the data being largely positive across multiple clinically relevant, independently assessed endpoints, suggests that afatinib may be a more effective treatment option than gefitinib in the first-line setting.”


Paz-Ares L, Tan E-H, O’Byrne K, et al. Afatinib versus gefitinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: overall survival data from the phase IIb LUX-Lung 7 trial.Ann Oncol; Advance online publication 7 February 2017. DOI: https://doi.org/10.1093/annonc/mdw611

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