Study Design   |   PFS   |   TTF   |   ORR   |   Safety

 

LUX-Lung 7 Clinical Trial

Afatinib compared with gefitinib for 1st-line treatment in EGFR M+ NSCLC.

Read the original LUX-Lung 7 publication.


Study design

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


PFS

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

LUX-Lung 7: PFS1

Adapted from Park K, et al. 2016.1

PFS at 2 years of 18% (n=21) compared with 8% (n=7) for afatinib compared with gefitinib, respectively.1


TTF

Afatinib in 1st-line significantly improved TTF* compared with gefitinib1

LUX-Lung 7: TTF1

Adapted from Park K, et al. 2016.1


ORR

Afatinib in 1st-line significantly improved response rates compared with gefitinib1

LUX-Lung 7: ORR1

Adapted from Park K, et al. 2016.1


Safety

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


References

1
Park K, et al. Lancet Oncol 2016;17(5):577–589.
2
Paz-Ares L, et al. Ann Oncol 2017;28(2):270–277.