New data show Giotrif® (afatinib) provided more than one year additional survival for lung cancer patients with the most common type of EGFR mutation (del19) compared to chemotherapy

Boehringer Ingelheim today announced results of the pre-specified individual, as well as the exploratory combined, analyses of two Phase III trials (LUX-Lung 3 and LUX-Lung 6). These data, to be presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO), demonstrated for the first time that patients with NSCLC with the most common epidermal growth factor receptor (EGFR) mutation (exon 19 deletions; del19) lived more than one year longer if treated with first-line afatinib compared to chemotherapy.¹

Del19 is the most common type of EGFR mutation. It accounts for 50% of all EGFR mutations. The prevalence of EGFR mutations is approximately 40% among Asian patients and 10-15% among Caucasian patients with lung adenocarcinoma.^2,3,4 For patients with the del19 mutation afatinib prolonged survival by 12.2 months versus chemotherapy in the LUX-Lung 3 trial, and 13.0 months versus chemotherapy in the LUX-Lung 6 trial. ¹

Principal investigator Professor James Chih-Hsin Yang, M.D., Ph.D., National Taiwan University Hospital in Taiwan commented: “NSCLC patients with the del19 EGFR mutation lived a median of more than one year longer if they started treatment with afatinib rather than standard chemotherapy. Afatinib is the first treatment to demonstrate an overall survival benefit for these patients.
LUX-Lung 3 and LUX-Lung 6 represent a potential change in the use of personalised medicine for treating patients with NSCLC. I think that these data support afatinib as the treatment of choice for patients with the del19 mutation.”

Afatinib: approved and investigational indications

Afatinib (GIOTRIF® / GILOTRIF®) is indicated for the treatment of distinct types of EGFR mutation-positive NSCLC. Afatinib is approved in a number of markets, including the EU, Japan, Taiwan and Canada under the brand name GIOTRIF® and in the U.S. under the brand name GILOTRIF®. It is under regulatory review in other countries. Phase III trials in squamous head and neck cancer (HNSCC) and trials in other tumour types are ongoing.

References

1. Yang J, Sequist L et al. Overall survival (OS) in patients with advanced non-small cell lung cancer (NSCLC) harbouring common (Del19/L858R) Epidermal Growth Factor Receptor mutations (EGFR mut): pooled analysis of two large open-label phase III studies (LUX-Lung 3 [LL3] and LUX-Lung 6 [LL6] comparing afatinib with chemotherapy. Abstract #8004 presented at 2014 American Society of Clinical Oncology, 50th Annual Meeting, 30 May–3 June 2014, Chicago, IL, USA
2. Quest Diagnostics – Lung Cancer Mutation Panel; http://www.questdiagnostics.com/hcp/intguide/jsp/showintguidepage.jsp?fn=TS_LungCancerMutation_Panel.htm
3. Yang J et al. J Clin Oncol 2013;DOI: 10.1200/JCO.2012.46.1764
4. Wu Y-L et al. J Clin Oncol 2014;DOI:10.1016/S1470-2045(13)70604-1