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Lux Lung 8 Clinical Data
GIOTRIF® (afatinib) showed superior OS versus erlotinib in patients with unselected squamous NSCLC after chemotherapy1

LUX-Lung 8: OS (key secondary endpoint)

LUX-Lung 8: OS (key secondary endpoint)

  • 19% relative reduction in the risk of death versus erlotinib (HR=0.81; P=0.0077)1
  • The survival benefit was evident from the first pre-specified time point measured at 6 months and maintained at 18 months1
  • OS benefit consistent across clinically relevant subgroups1
  • OS unlikely to have been affected by subsequent therapies, as a similar proportion of patients in both arms received additional treatment(s)1

CI=confidence interval; HR=hazard ratio; NSCLC=non-small cell lung cancer; OS=overall survival.

GIOTRIF® (afatinib) significantly increased PFS versus erlotinib in patients with unselected squamous NSCLC after chemotherapy1

LUX-Lung 8: PFS by independent review at time of OS analysis (2015) (primary endpoint)

LUX-Lung 8: PFS by independent review at time of OS analysis (2015) (primary endpoint)

  • 19% reduction in relative risk of disease progression versus erlotinib (median 2.6 months vs 1.9 months [HR=0.81; 95% CI, 0.69–0.96; P=0.0103])1

CI=confidence interval; HR=hazard ratio; NSCLC=non-small cell lung cancer; PFS=progression-free survival.

GIOTRIF® (afatinib) improved cough and quality of life versus erlotinib in squamous NSCLC following chemotherapy1

LUX-Lung 8: improvement in symptoms

LUX-Lung 8: improvement in symptoms

  • More patients had improved overall health-related quality of life with GIOTRIF® than with erlotinib (36% vs 28%; P=0.041)1
  • Patients on GIOTRIF® (afatinib) had significantly better mean EORTC scores for cough compared to erlotinib over time1
  • GIOTRIF® (afatinib) also significantly delayed deterioration of dyspnoea (median 2.6 months vs 1.9 months [HR=0.79; 95% CI, 0.66– 0.94; P=0.0078]) with favourable trends noted in delaying deterioration of cough and global health status/quality of life1

Rationale for targeting ErbB in squamous NSCLC

 

Squamous NSCLC is characterised by a high mutation rate and complex genomic alterations. Nevertheless, a comprehensive genomic analysis of 178 tumours by the Cancer Genome Atlas Research Network identified a potentially targetable gene or pathway alteration in 96% samples studied. Multiple genes and pathways are affected, including alterations in the ErbB family of receptors and their associated signalling pathways. Genomic analysis has identified potential oncogenic drivers in SCC, including ErbB family, FGF receptor (FGFR) family, PI3K pathway and DDR2.2 

CI=confidence interval; EGFR M+=epidermal growth factor receptor mutation positive; EORTC=European Organisation for Research and Treatment of Cancer; HR=hazard ratio; HRQoL=health-related quality of life; NSCLC=non-small cell lung cancer.


You may be interested in:

Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung (LUX-Lung 8): an open-label randomised controlled phase 3 trial

Soria et al., The Lancet Oncology, Volume 16, Issue 8, August 2015, Pages 897-907

Download the publication!

Listen to Dr. Marianne Nicolson, Dr. Filippo De Marinis and Dr. Enriqueta Felip discuss overall survival results from LUX-Lung 8, a multi-national phase III trial comparing GIOTRIF® (afatinib), an ErbB family blocker, to a first generation EGFR tyrosine kinase inhibitor TKI, Tarceva® (erlotinib).

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References

  1. Soria JC et al. Lancet Oncol. 2015;16(8):897-907.
  2. Heist RS et al. J Thorac Oncol. 2012;7(5):924–33.
  3. Park K et al. Lancet Oncol. 2016;17(5);577-589.
  4. Yang JC et al. J Clin Oncol. 2013;31(27):3342-3350.
  1. Sequist LV et al. J Clin Oncol. 2013;31(27):3327-3334.

  2. Wu YL et al. Lancet Oncol. 2014;15(2):213-222.

  3. Yang JC et al. Lancet Oncol. 2015;16(2):141-151.

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

  5. Soria JC et al. Lancet Oncol. 2015;16(8):897-907.

  6. Solca F et al. J Pharmacol Exp Ther. 2012;343(2):342-350.

  7. Yang JC et al. J Clin Oncol. 2013;31(27):3342-3350.

  8. Hirsch V et al. Poster #369 presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; Chicago, IL, USA; 3-7 June 2016.

  9. Yang JCH et al. Ann Oncol. 2016;27(11):2103-2110.

  10. Schuler M et al. J Thorac Oncol. 2016;11(3):380-390.

  11. Paz-Arez L et al. Ann Oncol. 2017; doi: 10.1093/annonc/mdw611.

  12. GIOTRIF® (afatinib) Summary of Product Characteristics, 2016.

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