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A Phase IIb Trial of Afatinib vs Gefitinib for the Treatment of First-Line Epidermal Growth Factor Receptor Mutation-Positive Adenocarcinoma of the Lung
A randomised, open-label Phase IIb trial of afatinib* vs gefitinib as first-line treatment of patients with common epidermal growth factor receptor (EGFR) mutations (del19/L858R) and advanced adenocarcinoma of the lung.
Trial CT.gov-Identifier: NCT01466660
Stage IIIB/IV lung adenocarcinoma
Positive for common EGFR mutations (del19/L858R)
No prior chemotherapy for non-small cell lung cancer (NSCLC)
No prior treatment with EGFR inhibitors
Stable brain metastases at baseline permitted
Eastern Cooperative Oncology Group performance status of 0–1
Primary outcome measures:
Secondary outcome measures:
Afatinib significantly improved PFS of patients with EGFR mutation-positive NSCLC relative to gefitinib (hazard ratio [HR]=0.73 [95% confidence interval [CI]: 0.57–0.95], p=0.0165). Risk of progression was reduced by 27%. Results were consistent across subgroups including EGFR mutation subgroups.
Afatinib treatment was associated with a significant (p=0.0073) improvement in TTF (time from randomisation to discontinuation for any reason). Risk of treatment failure was reduced by 27%. The improvement in efficacy was observed in both del19 and L858R populations.
A trend towards improved OS was observed with afatinib compared with gefitinib, although this was not statistically significant (HR=0.85 [95% CI: 0.66–1.09], p=0.1950). Consistent OS outcomes were observed across all age groups and EGFR mutation subgroups.
ORR and duration of response:
ORR (by independent central review) in the overall population was significantly improved with afatinib vs gefitinib with the median duration of response being 10.1 months (95% CI: 7.8–11.1) with afatinib vs 8.4 months (95% CI: 7.4–10.9) with gefitinib.
Adverse events (AEs) in both groups were consistent with previous experience, and were manageable leading to equally low rates of treatment discontinuation (rate of drug-related AEs leading to discontinuation was 6.3% for both treatment groups).
LUX-Lung 7 confirms the benefit of irreversible ErbB blockade with afatinib over reversible EGFR inhibition with gefitinib in the treatment of EGFR mutation-positive NSCLC.
Park K, et al. Lancet Oncol 2016; 17(5):577–589.
Paz-Ares L, et al. Ann Oncol 2016; 27 (Suppl 6): Abstract LBA43.
Clinicaltrials.gov. https://clinicaltrials.gov/ct2/show/NCT01466660 (Accessed: July 2017).
Corral J, et al. Poster presented at ELCC 2017; Abstract 93PD.
*Afatinib is approved in more than 70 markets including the EU, Japan, Taiwan, and Canada under the brand name GIOTRIF®, in the US under the brand name GILOTRIF® and in India under the brand name Xovoltib®; for the full list please see here. Registration conditions differ internationally; please refer to locally approved prescribing information.
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