GIOTRIF® (afatinib) is approved in the European Union and other countries for the treatment of patients with metastatic NSCLC whose tumours have epidermal growth factor receptor (EGFR) mutations.

In the U.S., afatinib is approved under the brand name GILOTRIF™. For more information about GILOTRIF™, please visit the US website.

What is GIOTRIF®

  • GIOTRIF® is an irreversible ErbB Family Blocker of epidermal growth factor receptor (EGFR), HER2, ErbB3 and ErbB4 signalling.
  • Members of the ErbB Family play a critical role in the growth and spread of the most pervasive cancers and cancers associated with high mortality.
  • The covalent and, therefore, irreversible binding of GIOTRIF® is unlike other compounds which show reversible binding.
  • GIOTRIF® provides a sustained, selective, and complete ErbB Family Blockade.1,2

PFS=progression-free survival; QoL=quality of life.
* vs pemetrexed/cisplatin in prespecified subgroup of patients with common mutations (del19/L858R); 
** Secondary endpoint, primary endpoint was PFS; combined post-hoc analysis of common EGFR mutations (del19/L858R) vs chemotherapy (LUX-lung 3 vs pemetrexed/cisplatin and LUX-Lung 6 vs gemcitabine/cisplatin).

 

Overall survival (OS) benefit as 1st-line treatment in EGFR M+ NSCLC patients vs. chemotherapy*

 

ITT=intent to treat; OS=overall survival

* Secondary endpoint, primary endpoint was PFS; combined post-hoc analysis of common EGFR mutations (Del19/L858R) vs chemotherapy (LUX-lung 3 vs pemetrexed/cisplatin and LUX-Lung 6 vs gemcitabine/cisplatin).

  • GIOTRIF® is the first targeted therapy that provides a significant overall survival (OS) benefit for NSCLC patients with common EGFR mutations vs. chemotherapy as a first line treatment.*
  • GIOTRIF® extended median OS of EGFR M+ NSCLC patients vs. first line chemotherapy significantly by 3 months.*3

* pre-specified LUX-Lung 3 analysis vs. pemetrexed/cisplatin in NSCLC patients with Del19 mutations

  

  • In addition GIOTRIF® showed for EGFR M+ NSCLC patients vs. pemetrexed/cisplatin (LUX-Lung 3) 4
    • a significant delay in tumour progression (PFS 13.6 vs. 6.9 months)
    • clinically meaningful improvements in their lung cancer related symptoms
    • significant improvements in quality of life
  • The most common grade 3 drug-related adverse events observed in the GIOTRIF® treatment arm in the LUX-Lung 3 trial were diarrhoea (14%), rash (16%), and paronychia (11%). The side effects were manageable.
  • The discontinuation rate associated with treatment-related adverse events of GIOTRIF® was low (8%) in the LUX-Lung 3 trial.4

References

  1. Solca F, Dahl G, Zoephel A, et al. Target binding properties and cellular activity of afatinib (BIBW 2992), an irreversible ErbB family blocker. J Pharmacol Exp Ther 2012;343:342-50.
  2. Reid A, Vidal L, Shaw H, do Bono J. Dual inhibition of ErbB1 (EGFR/HER1) and ErbB2 (HER2/neu). Eur J Cancer 2007;43:481-9.
  3. Yang JC et al. ASCO oral presentation and abstract. J Clin Oncol 32:5s, 2014 (suppl; abstr 8004).
  4. Sequist L, Yang J, Yamamoto N, et al. Phase III Study of Afatinib or Cisplatin Plus Pemetrexed in Patients With Metastatic Lung Adenocarcinoma With Epidermal Growth Factor Receptor Mutations. J Clin Oncol 2013;31:3327-3334.
  5. Yang J, Hirsh V, Schuler M, et al. Symptom Control and Quality of Life in LUX-Lung 3: A Phase III Study of Afatinib or Cisplatin/Pemetrexed in Patients With Advanced Lung Adenocarcinoma With Epidermal Growth Factor Receptor Mutations. J Clin Oncol 2013;31:3342-3350.