What is the role of afatinib (Gilotrif) in the treatment of non-small cell lung cancer (NSCLC)?

Updated: Aug 21, 2019
  • Author: Maurie Markman, MD, MS; Chief Editor: Keith K Vaux, MD  more...
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Afatinib (Gilotrif) is a tyrosine kinase inhibitor that was approved in the United States in July 2013 for first-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by the diagnostic companion test, therascreen EGFR RGQ PCR Kit. In 2018, the indication for first-line use in metastatic NSCLC was expanded to include 3 additional nonresistant EGFR mutations (ie, L861Q, G719X, S768I). [21] Approval was based on data from the LUX-Lung 3 trial, comparing afatinib to chemotherapy with pemetrexed/cisplatin. Results showed the afatinib group’s progression-free survival (PFS) was 11.1 months, as compared to 6.9 months for those treated with pemetrexed/cisplatin. Additionally, patients with tumors expressing the 2 most common EGFR mutations (Del19 or L858R) taking afatinib lived over a year without tumor progression (PFS of 13.6 mo), as compared to 6.9 months for those in the comparator arm. [22]

The frontline indication for afatinib was expanded to include the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors harbor uncommon EGFR alterations in L861Q, G719X, and/or S768I.

Approval is based on a pooled analysis of 3 studies from the LUX-Lung clinical trial program (phase II LUX-Lung 2 study and phase III studies LUX-Lung 3 and LUX-Lung 6) that examined afatinib in NSCLC patients whose tumors have EGFR mutations, including L861Q, G719X, or S768I. This analysis showed that afatinib was active in these EGFR mutations based on objective response rate, duration of response, disease control, progression-free survival, and overall survival. [23]

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