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InOncology.com

LUX-Lung 7 clinical trial

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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

Patients

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

 

N=319

Randomisation 1:1

Afatinib 40 mg Oral once daily
Gefitinib 250 mg Oral once daily

Endpoints

Primary outcome measures:

  • Progression-free survival (PFS), assessed by independent central review
  • Time-to-treatment failure (TTF)
  • Overall survival (OS)

 

Secondary outcome measures:

  • Objective response rate (ORR)
  • Time to and duration of objective response
  • Duration of disease control
  • Tumour shrinkage
  • Health-related quality of life (HRQoL)

Results

PFS:

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.

Hazard ratio = 0.73 95% CI = 0.57–0.95
LUX-Lung 7: figure for progression-free survival (PFS) with afatinib vs gefitinib

TTF:

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.

Hazard ratio = 0.73 95% CI = 0.58–0.92
LUX-Lung 7: figure for time to treatment failure (TTF) with afatinib vs gefitinib

OS:

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.

Hazard ratio = 0.85 95% CI = 0.66–1.09
LUX-Lung 7: figure for progression-free survival (PFS) with afatinib vs gefitinib

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.

LUX-Lung 7: figure for objective response rate (ORR) with afatinib vs gefitinib

Safety:

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).

Conclusion

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.

 

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References

1

Park K, et al. Lancet Oncol 2016; 17(5):577–589.

2

Paz-Ares L, et al. Ann Oncol 2016; 27 (Suppl 6): Abstract LBA43.

3

Clinicaltrials.gov. https://clinicaltrials.gov/ct2/show/NCT01466660 (Accessed: July 2017).

4

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.