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 80 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.
Using this link will let you leave a website of Boehringer Ingelheim International GmbH (“BI”) or to a different domain under the control of BI. In the event that the linked site is not under the control of BI but under the control of a third party or an affiliate in the Boehringer Ingelheim group of companies, BI shall not be responsible for the contents, processing of personal data of any linked site or any link contained in a linked site, or any changes or updates to such sites. This link is provided to you only as a convenience, and the inclusion of any link does not imply endorsement by BI of the site.
Do you want to continue ?Continue