GIOTRIF® vs gefitinib for 1st-line treatment of EGFRm+ NSCLC

Document ID: PC-SG-101158

01/07/2020

Author: Boehringer Ingelheim


2nd-generation EGFR-TKIs differ from the 1st-generation inhibitors (or EGFR-TKIs) in their mechanism of action, with the former having broad spectrum activity and irreversible binding to EGFR receptors, which may result in an improved inhibition of tumour growth. The LUX-Lung 7 trial evaluated the efficacy of 1st-line GIOTRIF® vs gefitinib in patients with common EGFR mutations.4

GIOTRIF® provided faster and improved objective response vs gefitinib4

  • The proportion of patients who achieved an objective response was significantly higher with GIOTRIF® vs gefitinib (70% vs 56%; OR: 1.87 [95% CI: 1.18-2.99]; p=0.0083)
  • Tumour shrinkage was observed as early as week 4 with a difference between the two arms.4

GIOTRIF® demonstrates deeper tumour shrinkage vs gefitinib in L858R patients4

  • The proportion of patients achieving an objective response with GIOTRIF® was more pronounced in patients with L858R mutations4
  • A larger proportion of patients exhibited a ≥50% consistent decrease in tumour size with GIOTRIF® compared to gefitinib (39% vs 21%)4

References & Footnote:

1. Sequist LV et al. J Clin Oncol. 2013;31(27):3327-3334.
2. Wu YL et al. Lancet Oncol. 2014;15(2):213-22.
3. Yang JC et al. Lancet Oncol. 2015;16(2):141-51.
4. Park K et al. Lancet Oncol 2016;17(5):577–89.

CI = confidence interval; EGFR M+=epidermal growth factor receptor mutation positive; EGFR-TKI = epidermal growth factor receptor tyrosine kinase inhibitor; IQR = inter-quartile range; NSCLC=non-small cell lung cancer; PFS=progression-free survival; ORR = objective response rate; OR =odds ratio; OS=overall survival; CI = confidence interval; IQR = inter-quartile range
* LUX-Lung 3 (vs pemetrexed/cisplatin) and LUX-Lung 6 (vs gemcitabine/cisplatin): superior PFS (primary endpoint) and superior OS in Del19 subgroup (secondary endpoint); LUX-Lung 7 (vs gefitinib): superior PFS (primary endpoint).

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PC-SG-101158
Production date: July 2021

What is Afatinib (Giotrif®)?

Afatinib (Giotrif®) is an irreversible ErbB Family blocker approved in more than 70 countries. It is indicated for the treatment of patients with distinct types of epidermal growth factor receptor mutation-positive (EGFR M+) locally advanced or metastatic non-small cell lung cancer (NSCLC), and for the treatment of patients with locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy. It is an oral, once-daily, targeted therapy.[1]

*Afatinib is approved in more than 70 countries 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®
 

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about Afatinib (Giotrif®)?

The side effects of Afatinib are predictable, generally manageable and reversible. In studies to date, drug-related adverse events (AEs) were largely related to the gastrointestinal tract (diarrhoea) and skin disorders (rash), which is in line with EGFR tyrosine kinase inhibition.[1-4] For further details, please refer to the Local Prescribing Information.

References:
[1] GIOTRIF® Summary of Product Characteristics 2018
[2] Sequist L et al. J Clin Oncol 2013;31(27)3327–34.
[3] Wu YL et al. Lancet Oncol 2014;15(2):213–22.
[4] Park K et al. Lancet Oncol 2016;17(5):577–89.