• Real-world studies explore patient outcomes in populations more representative of clinical practice than prospective clinical trials1

• Real-world data can provide clinically meaningful insights that can be applied to patient care1

*Afatinib is approved in more than 80 markets, 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®. Registration conditions differ internationally; please refer to locally approved prescribing information.

**Time on treatment is defined from the start of first-line treatment until the end of second-line treatment.

EGFR, epidermal growth factor receptor; NSCLC, non-small cell lung cancer; PD, progressive disease; TKI, tyrosine kinase inhibitor.

1. Schilsky RL. J Am Coll Surg 2017;224:1–7; 2. Yu HA, et al. Clin Cancer Res 2013;19:2240–7; 3. Mok T, et al. N Engl J Med 2017;376:629–40; 4. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03370770 (Accessed: 12 April 2018); 5. Sequist L, et al. Ann Oncol 2017:28(Suppl.5): v460–v496.

European Union Summary of Product Characteristics.

This information is from an international website which is intended for healthcare professionals not located in the United States of America (US) and the United Kingdom (UK). Afatinib is subject to country-specific regulations and the approved product label may vary from country to country. Information on this website is derived from the approved European Summary of Product Characteristics. Please refer to your local product label for full details.

Copyright © 2018 Boehringer Ingelheim International GmbH. This document and its contents are property of Boehringer Ingelheim (third-party sources are indicated) and are, inter alia, protected by copyright law. Complete or partial passing on to third parties, as well as copying, reproduction, publication or any other use by third parties is not permitted.

All rights are reserved. June 2018 Vault ID: SC-CRP-02023

GIOTAG: A REAL-WORLD STUDY OF AFATINIB FOLLOWED BY OSIMERTINIB SEQUENTIAL THERAPY IN EVERYDAY CLINICAL PRACTICE

A non-interventional study based on existing medical records of patients with EGFR mutation-positive advanced NSCLC treated with afatinib* as the first-line treatment followed by osimertinib for T790M resistance mutation patients

GioTag study background• Approximately 50–60% of patients with EGFR mutation-positive NSCLC have tumours that will develop a T790M resistance mutation following

treatment with a first- or second-generation TKI;2 osimertinib, which specifically targets the T790M mutation, is approved for use in this patient population3

• The GioTag study will generate data on the use of two sequential targeted therapies in EGFR mutation-positive NSCLC and data on resistance mutations after treatment4

– An exploratory analysis of afatinib followed by osimertinib in patients with EGFR mutation-positive (Del19/L858R) NSCLC showed an unexpectedly long time on treatment, warranting further investigation5

228

13

PATIENTS

COUNTRIES

FROM

Study objectives

65

11

STUDY SITES

COUNTRIES

IN

Europe• Austria• Germany• Italy• Slovenia• Spain

Primary objective:Time on treatment**with afatinib followedby osimertinib for T790Mresistance mutation

Secondary objective:To collect data on theacquired resistancemechanism to osimertinib

Asia• Israel• Japan• Singapore• Taiwan

North America• Canada• USA

N=190

Patients with EGFRmutation-positiveadvanced NSCLC

(Del19, L858R)

First-linetreatment

with afatinib until PD

Acquisitionof T790M

Second-linetreatment with

osimertinib

Patients who initiated second-line osimertinib treatment for acquired T790M mutation at least

10 months prior to data entry

Data collection from existing medicalrecords between Q4 2017 and Q2 2018

Final report expected Q4 2018