GIOTRIF® (afatinib) in 1st-line EGFR
M+ NSCLC

GIOTRIF® (afatinib) as monotherapy is indicated for patients with locally advanced or metastatic NSCLC with activating EGFR mutations not previously treated with EGFR TKIs.

 

 


GIOTRIF® (afatinib) has proven efficacy across EGFR NSCLC subpopulations

GIOTRIF® (afatinib) has demonstrated efficacy in patients with uncommon mutations*2

A post hoc pooled analysis of prospectively collected data from LUX-Lung 2, 3 and 6 demonstrated GIOTRIF® (afatinib) efficacy in patients harboring certain uncommon mutations.*2-5

 

PFS

LUX-Lung 2, 3 and 6: PFS in patients with selected uncommon mutations2

Mutation type

Median PFS, months (95% CI)

G719X(n=18)

13.8 (6.8-NE)

L861Qb (n=16)

8.2 (4.5-16.6)

S768Ic (n=8)

14.7 (2.6-NE)

Mutation type

G719X(n=18)

L861Qb (n=16)

S768Ic (n=8)

Median PFS, months (95% CI)

13.8 (6.8-NE)

8.2 (4.5-16.6)

14.7 (2.6-NE)

 

a G719X (n=8), G719X + T790M (n=1), G719X + S768I (n=5), G719X + L861Q (n=3), G719X + T790M + L858R (n=1). L861Q (n=12), L861Q + G719X (n=3), L861Q + Del19 (n=1). S768I (n=1), S768I + G719X (n=5), S768I + L858R (n=2)

 

Adapted from Yang JC, et al. 2015.2

 

ORR

LUX-Lung 2, 3 and 6: ORR in patients with selected uncommon mutations2

Chart with ORR in patients with selected uncommon mutations2

Adapted from Yang JC, et al. 2015.2

a G719X (n=8), G719X + T790M (n=1), G719X + S768I (n=5), G719X + L861Q (n=3), G719X + T790M + L858R (n=1).

b L861Q (n=12), L861Q + G719X (n=3), L861Q + Del19 (n=1).

c S768I (n=1), S768I + G719X (n=5), S768I + L858R (n=2).


GIOTRIF® (afatinib) in 1st-line has been shown to delay CNS progression and onset of brain metastases

Risk of CNS progression in patients with baseline brain metastases

LUX-Lung 3 and 6: competing risk analysis for progression in patients with baseline metastases6

LUX-Lung 3 and 6: chart with competing risk analysis for progression in patients with baseline metastases

Adapted from Girard N. 2018.

  • Data censored in 8 of 48 patients (16.7%).
  •  

Risk of CNS progression in patients without baseline brain metastases6 

LUX-Lung 3, 6 and 7: competing risk analysis for progression in patients without baseline metastases6

LUX-Lung 3, 6 and 7: chart with competing risk analysis for progression in patients without baseline metastases

Adapted from Girard N. 2018.

  • Data censored in 74 of 485 patients (15.3%).

Real-world evidence

GIOTRIF® (afatinib) demonstrated comparable efficacy in patients with and without brain metastases in a setting similar to real-world practice7

  • In a Phase IIIb, open-label, single-arm study in Asian patients with EGFR M+ NSCLC, similar to real-world practice, baseline brain metastases were present in 92 of 479 patients

  • In an interim analysis of this trial, median PFS was 10.9 months in patients with brain metastases vs. 12.4 months in patients without brain metastases; median time to symptomatic progression was 14.8 and 15.4 months, respectively

GIOTRIF® (afatinib) demonstrated efficacy in Korean patients with brain metastases in real-world practice8

  • A retrospective study was carried out in 165 Korean patients receiving GIOTRIF® (afatinib) 1st-line for the treatment of EGFR M+ NSCLC
  • Of patients who had brain tumours, but did not received radiotherapy, 29 had follow up MRI data, 22 of which (76%) had brain metastases that had significantly responded to treatment

Want to learn about GIOTRIF® (afatinib) in squamous cell carcinoma? Click here to find out more.

Want to learn about the mechanism of action of GIOTRIF® (afatinib)? Click here to find out more.


*Uncommon mutations consisted of patients with all point mutations or duplications in exons 18–21 (Leu861GIn, Gly719Ser, Gly719Ala, Gly719Cys, Ser768lle and other rare mutations), but not de novo Thr790Met mutations and exon 20 insertions.2

CNS=central nervous system, EGFR M+=epidermal growth factor receptor mutation positive, NE=not estimable, NSCLC=non-small-cell lung cancer, ORR=objective response rate, PD=progressive disease, PFS=progression free survival

 


References

1
GIOTRIF® (afatinib), Summary of Product Characteristics, 2018.
2
Yang JC, et al. Lancet Oncol 2015;16(2):141–151..
3
Yang JC, et al. Lancet Oncol 2012;13(5):539–548.
4
Sequist LV, et al. J Clin Oncol 2013;31(27):3327–3334.
5
Wu YL, et al. Lancet Oncol 2014;15(2):213–222.
6
Girard N. Future Oncol 2018;14(11):1117–1132.
7
Wu Y-L, et al. Poster presented at the World Conference on Lung Cancer (WCLC); Toronto, Canada, 23–26 September 2018 (Poster P1.01-98).
8
Kim Y, et al. J Thorac Oncol 2017;12:S2209.
Back to top

This site uses cookies to improve your browsing experience. By using this site, you agree to their use.

Cookie policy
I am a Healthcare Professional outside the US and UK

I am a Healthcare Professional outside the US and UK

Click here for international product information intended for Healthcare Professionals about afatinib for non-small-cell lung cancer treatment.

I am not a Healthcare Professional and I am outside the US and the UK

I am not a Healthcare Professional and I am outside the US and the UK

Click here for general international information about afatinib for non-small-cell lung cancer treatment.

Country-specific product information

Country-specific product information

Click here for country-specific product information intended for Healthcare Professionals about afatinib for non-small-cell lung cancer treatment.