GIOTRIF® provides ≥3 years long-term response even with dose modification

Document ID: PC-SG-101160

01/07/2020

Author: Boehringer Ingelheim


Long-term responders (LTRs) to targeted therapeutics, remain on therapy for prolonged periods and show improved tumour responses.5
Identifying and determining the patient or tumour characteristics of this subset of patients is useful.

A post-hoc analysis of the LUX-Lung 3, 6 and 7 trials identified a subset of patients who received ≥3 years of GIOTRIF® treatment as LTRs.5

Patients treated for at least 2, 2.5 and 3 years in the Overall LL3/6/7 populations5

  • 10% patients in LL3 and LL6 and 12% patients in LL7 were identified as LTRs5
  • The proportion of LTRs was higher with GIOTRIF® (12%) vs gefitinib (4%) in LL75

Long-term GIOTRIF® treatment was independent of tolerability-guided dose adjustment5

  • A majority of the LTRs underwent tolerability-guided dose adjustments and yet could obtain sustained clinical benefit with GIOTRIF®5
  • Median (range) duration of treatment was 50 (41-73) months in LL3, 56 (37-68) months in LL6 and 42 (37-50) months in LL75
  • 75% (18/24) of LTRs in LL3 had tolerability-guided dose reduction of afatinib to <40 mg/day
  • mPFS was 49.5 months in LL3, mOS not reached with a median follow-up time of 64.6 months

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. Schuler M, et al. Lung Cancer. 2019;133:10-19.

EGFR M+=epidermal growth factor receptor mutation positive; LTR = long-term responder; NSCLC=non-small cell lung cancer; PFS=progression-free survival; OS=overall survival; LL3 = LUX-Lung 3; LL6 = LUX-Lung 6; LL7 = LUX-Lung 7.
* 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-101160
Production date: Jul 2020

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.