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GIOTRIF® delays onset and risk of CNS progression in patients with or without brain metastases

01/07/2020  |  Author: Boehringer Ingelheim

Document ID: PC-SG-101159

Brain metastases occur in 13-44% of patients with lung cancer and are an indicator of poor prognosis, with median survival ranging between 4 and 6 months.5,6

GIOTRIF® demonstrated efficacy in delaying onset of CNS progression7

  • In patients with or without baseline brain metastases in the LUX-Lung 3 and 6 trials, median time to CNS progression was longer with GIOTRIF® vs chemotherapy.

GIOTRIF-delays-onset-risk-CNS

GIOTRIF® lowers risk of CNS progression in NSCLC patients without brain metastases8

  • In GIOTRIF®-treated patients without baseline brain metastases in LUX-Lung 3, 6 and 7, the cumulative incidence of CNS progression was 92% lower than that of non-CNS progression (6.4% vs 78.4%).

  • The risk of CNS progression was only 6.4% in patients without baseline brain metastases who received GIOTRIF®.8

GIOTRIF-delays-onset-risk-CNS

GIOTRIF® lowers risk of CNS progression in NSCLC patients with brain metastases8

  • In patients with baseline brain metastases who were treated with GIOTRIF® in LUX-Lung 3 and 6, the cumulative incidence of CNS progression was 40% lower than that of non-CNS progression (31% vs 52%).8

  • In majority of GIOTRIF®-treated patients with baseline brain metastases, the brain was not the site of first disease progression.7

GIOTRIF-delays-onset-risk-CNS
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.
  • 5.
     Di Lorenzo R and Ahluwalia M.S. Ther Adv Med Oncol. 2017;9(12):781-796.
  • 6.
     Lim JK and Um Sang-Won. Ann Transl Med. 2018;6(Suppl 1):S66.
  • 7.
     Schuler M, et al. J Thorac Oncol. 2016;11(3):380-390.
  • 8.
     Girard N. Future Oncol. 2018;14(11):1117-1132.
  •  CNS=central nervous system; EGFR M+=epidermal growth factor receptor mutation positive; NSCLC=non-small cell lung cancer; PFS=progression-free survival;
    RCT=randomised clinical trial; OS=overall survival.
  • *
     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).

EFFICACY

RWDRI||GIOTRIF® in Uncommon Mutation - A database analysis of > 1000 NSCLC Patients
GIOTRIF® delays onset and risk of CNS progression in patients with or without brain metastases
GIOTRIF vs gefitinib 1st line treatment EGFRm NSCLC
GIOTRIF® provides ≥3 years long-term response even with dose modification
Pre-clinical and clinical activity of GIOTRIF® in uncommon EGFR mutations
Sequential treatment with afatinib and osimertinib in patients with EGFR mutation-positive non-small-cell-lung cancer: an observational study
RWDRI||Real-World Effectiveness of GIOTRIF® vs Osimertinib - Data from Japan
RWDRI||Real-World Effectiveness of GIOTRIF® on Brain Metastases – Data from Korea and Taiwan
SEREAL||GIOTRIF® safety and effectiveness in the real world
SEREAL||Real-world evidence: GIOTRIF® in Japan
GIOTRIF® in elderly
GIOTRIF® RWE in uncommon EGFR mutations
GIOTRIF® RWE in South Korea
SEREAL||Impact of GIOTRIF® in delaying CNS progression
SEREAL||GIOTRIF® Uncommon EGFR pooled analysis in 693 patients
SEREAL||GIOTRIF® RWE in patients with brain metastases
SEREAL||GIOTRIF® RWE in Taiwan
SEREAL||GIOTRIF® efficacy in the real-world
SEREAL||GIOTRIF® in LUX-Lung 7
GIOTRIF® real world experience in Asia
Video: Uncommon EGFR pooled analysis in 693 patients

RELATED CONTENT

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.