Afatinib And Gefitinib OS Comparable For Advanced EGFR mutation-positive NSCLC

LUX-Lung 7 results do not show an overall survival advantage for afatinib over gefitinib in advanced non-small-cell lung cancer with an epidermal growth factor receptor mutation

medwireNews: Overall survival (OS) in epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC) patients is comparable with treatment using the tyrosine kinase inhibitors (TKIs) afatinib and gefitinib , LUX-Lung 7 results show.

The co-primary endpoint of median OS after a median of 42.6 months was 27.9 months for the 160 patients randomly assigned to receive afatinib 40 mg/day and 24.5 months for the 159 patients given gefitinib 250 mg/day. The hazard ratio (HR) was 0.86 in favour of afatinib but was not statistically significant.

OS analysis of subgroups based on age, gender, race, smoking, history, EGFR mutation and the presence or absence of brain metastases all showed a consistent trend towards afatinib superiority but again did not reach significance.

Subsequent use of EGFR TKIs was comparable in the patients in the afatinib and gefitinib groups, including the use of third-generation TKIs; similar OS was achieved in the afatinib and gefitinib groups with use of osimertinib or olmutinib.

The phase IIB trial findings for the head-to-head study of the irreversible ErbB family blocker afatinib and the reversible EGFR TKI gefitinib were reported at the ESMO 2016 congress, held in Copenhagen, Denmark.

The study included patients with stage IIIB/IV disease with a known EGFR deletion 19 and/or L858R mutation, a good ECOG performance status and no prior treatment for advanced or metastatic disease, explained presenting author Luis Paz-Ares, from the University of Madrid in Spain.

He also gave updated results for the co-primary endpoints of progression-free survival and time to treatment failure that were consistent with earlier reports of afatinib superiority, now giving significant HRs of 0.74 and 0.75, respectively. The latest findings for overall response rate also favoured afatinib, at 73% versus 56%, with median duration of response of 10.1 and 8.3 months, respectively.

The toxicity profile was also consistent with the primary report, the presenter said. Grade 3 or more severe events were more common with afatinib than gefitinib (31.3 vs 19.5%) including diarrhoea (13.1 vs 1.3%), rash/acne (9.4 vs 3.1%) and stomatitis (4.4 vs 0%), but there was a higher rate of alanine transaminase (0 vs 8.2%) and aspartate transaminase (0 vs 2.5%) elevations with gefitinib.

“The overall data, being largely positive across multiple clinically relevant endpoints, suggests that afatinib may be a more effective treatment option than gefitinib in the first-line setting and confers a manageable safety profile”, Paz-Ares concluded.


ESMO 2016 Congress; Copenhagen, Denmark: 7–11 October

LBA43 – Afatinib (A) vs gefitinib (G) in patients (pt) with EGFR mutation-positive (EGFRm+) non-small-cell lung cancer (NSCLC): overall survival (OS) data from the phase IIb trial LUX

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