LUX-Lung 7: PFS1
Global, open-label, exploratory, randomised controlled Phase IIB trial comparing 1st-line afatinib with the 1st-generation EGFR-TKI gefitinib in patients with EGFR mutation-positive advanced NSCLC (N=319). Patients were randomly assigned (1:1) to receive afatinib 40 mg once per day (n=160) or gefitinib 250 mg once per day (n=159) until disease progression, or beyond if deemed beneficial by the investigator. Co-primary endpoints were PFS by independent central review, TTF, and OS. Secondary endpoints included ORR, AEs and HRQoL.1
Afatinib in 1st-line significantly improved PFS* and reduced the risk of progression by 27% compared with gefitinib, with over twice as many patients progression-free at 2 years1
PFS at 2 years of 18% (n=21) compared with 8% (n=7) for afatinib compared with gefitinib, respectively.1
Afatinib in 1st-line significantly improved TTF* compared with gefitinib1
LUX-Lung 7: TTF1
Afatinib in 1st-line significantly improved response rates compared with gefitinib1
LUX-Lung 7: ORR1
The most common AEs with afatinib were diarrhoea, stomatitis, rash, acne and paronychia.1
*Co-primary endpoints were PFS, TTF, and OS. OS for afatinib compared with gefitinib was not statistically significant (median 27.9 vs. 24.5 months, respectively; HR=0.86; 95% CI: 0.66–1.09; p=0.1950).1,2
AE=adverse events, EGFR M+=epidermal growth factor receptor mutation positive, HRQoL=health-related quality of life, NSCLC=non-small-cell lung cancer, ORR=objective response rate, OS=overall survival, PFS=progression-free survival, TTF=time-to-treatment failure
- Park K, et al. Lancet Oncol 2016;17(5):577–589.
- Paz-Ares L, et al. Ann Oncol 2017;28(2):270–277.