Boehringer Ingelheim initiates real-world study of treatment sequencing in EGFR mutation-positive lung cancer
- GioTag study will assess the impact of sequential TKI therapy of afatinib followed by osimertinib for patients
- Data will increase our understanding on how sequencing of TKIs can extend chemotherapy-free treatment time
- The real-world study aims to include data from 65 study centres in 11 countries, including the United States
Ingelheim, Germany, 12 December, 2017 – Boehringer Ingelheim has initiated GioTag, a real-world study to assess the impact of sequential therapy in patients with EGFR mutation-positive (M+) advanced non-small cell lung cancer (NSCLC). Data from approximately 190 patients who received tyrosine kinase inhibitors (TKI) – afatinib* in first-line, followed by second-line osimertinib**as part of standard clinical practice – will be analysed to determine total time on treatment.
Dr Maximilian Hochmair, Medical Oncologist, Vienna, Austria and coordinating investigator in this trial commented, “Around 50-60% of patients with NSCLC will develop a T790M resistance mutation following treatment with a first- or second-generation TKI. But with osimertinib, which specifically targets the T790M mutation, a second-line targeted treatment is now a realistic option, helping to delay the use of chemotherapy even further. With more targeted treatments available, it is becoming important for clinicians to understand how to optimally sequence treatments to ensure the best outcomes are achieved. This real-world study will generate important insights on resistance mutations and sequencing to further inform long-term treatment planning.”
The study, a retrospective review, will analyse data from 65 study centres in 11 countries, to determine the time on treatment of afatinib as first-line therapy in EGFR M+ lung cancer followed by osimertinib for patients with T790M resistance mutation, in a real-world setting. Available data on mutations after treatment with osimertinib will also be collected. With limited information available on the results of sequential treatment with two targeted therapies, this study will provide insight into the impact of TKIs used in this patient population and subsequent chemotherapy treatment. The sequence of treatment with TKIs may be a key determinant of long-term patient outcomes in EGFR M+ NSCLC.
Dr Victoria Zazulina, Global Head of Solid Tumour Oncology, Medicine at Boehringer Ingelheim commented, “Treatment decision-making is becoming more complex due to the increasing number of treatment options that are now thankfully available for patients with EGFR mutation-positive lung cancer. By making more data available through this real-world study, we will know more about the impact of multiple lines of targeted therapy on patient outcomes. In addition, the data will provide valuable insights to guide our continued development of next-generation breakthrough therapies.”
Results from GioTag are expected to be available in 2018.
Notes to editors
Intended audiences
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.
About Afatinib
https://www.boehringer-ingelheim.com/sites/default/files/Documents/Afatinib_Backgrounder.pdf
About Boehringer Ingelheim in Oncology
https://www.boehringer-ingelheim.com/sites/default/files/Documents/Boehringer_Ingelheim_in_Oncology_Backgrounder.pdf
About Boehringer Ingelheim
Innovative medicines for people and animals have for more than 130 years been what the research-driven pharmaceutical company Boehringer Ingelheim stands for. Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies and to this day remains family-owned. Day by day, some 50,000 employees create value through innovation for the three business areas human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. In 2016, Boehringer Ingelheim achieved net sales of around 15.9 billion euros. With more than three billion euros, R&D expenditure corresponds to 19.6 per cent of net sales.
Social responsibility comes naturally to Boehringer Ingelheim. That is why the company is involved in social projects such as the “Making More Health” initiative. Boehringer Ingelheim also actively promotes workforce diversity and benefits from its employees’ different experiences and skills. Furthermore, the focus is on environmental protection and sustainability in everything the company does.
More information about Boehringer Ingelheim can be found on www.boehringer-ingelheim.com or in our annual report: http://annualreport.boehringer-ingelheim.com.
Footnotes
*Afatinib is approved in a number of markets, including the EU, Japan, China, Taiwan and Canada under the brand name Giotrif®, in the US under the brand name Gilotrif® and in India under the brand name Xovoltib® for use in patients with distinct types of EGFR mutation-positive NSCLC. Afatinib is also approved in the EU, US and other markets for the treatment of patients with advanced SqCC of the lung whose disease has progressed (on or) after treatment with platinum-based chemotherapy. Afatinib is under regulatory review by health authorities in other countries worldwide. Registration conditions differ internationally, please refer to locally approved prescribing information.
**Osimertinib is indicated for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC