Boehringer Ingelheim, Germany, August 09, 2018 – Boehringer Ingelheim today announced it had completed the enrolment for GioTag, a real-world, retrospective study based on analysis of data from medical/electronic health records to assess the impact of sequential therapy in patients with epidermal growth factor receptor (EGFR) mutation-positive metastatic non-small cell lung cancer (NSCLC). A total of 204 patients from 10 countries who sequentially received tyrosine kinase inhibitors (TKIs) – Giotrif® (afatinib) in first-line, followed by second-line osimertinib – were enrolled.
The study was initiated in December 2017 and the primary outcome was the time on treatment of first-line afatinib followed by osimertinib in patients who developed the T790M resistance mutation, in a real-world setting.
The study aims to provide insight into EGFR TKI sequencing strategy and its impact on delaying the onset of chemotherapy to help inform treatment approaches for EGFR mutation-positive NSCLC. Results are expected to be shared later this year.
“Further investigation is needed on the importance of EGFR TKI sequencing for patients with EGFR mutation-positive NSCLC. With more treatment options becoming available, doctors will have to plan beyond one line of targeted treatment keeping the bigger picture in mind right from the diagnosis,” said Dr Victoria Zazulina, Global Head of Solid Tumour Oncology, Medicine at Boehringer Ingelheim. “GioTag is one of the approaches to generate such evidence in the real-world setting and answer the “sequencing” question complementing the data collected in randomised clinical trials.”
Real-world evidence plays an increasingly important role in building the oncology community’s understanding of cancer medicines and their use in patients outside of a clinical trial environment.
Randomised Controlled Trials and Real-World Studies
Randomised controlled trials (RCTs) are designed to assess the efficacy and safety of study drugs under well-defined conditions and in selected patient populations. In contrast, real-world studies include everyday patients with characteristics that might preclude their participation in a RCT. Real-world studies are complementary to RCTs, and explore patient outcomes in populations more representative of clinical practice than prospective clinical trials. Real-world studies are essential for capturing clinically relevant data at the point of care, and providing clinically meaningful insights that can be applied to patient care.
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
Afatinib is approved in many countries worldwide 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 squamous cell carcinoma of the lung whose disease has progressed (on or) after treatment with platinum-based chemotherapy. Registration conditions differ internationally, please refer to locally approved prescribing information.
https://www.boehringer-ingelheim.com/sites/default/files/Documents/Afatinib_Backgrounder.pdf
About Boehringer Ingelheim in Oncology
Cancer takes away loved ones, time and untapped potential. At Boehringer Ingelheim we are providing new hope for patients by taking cancer on. We are collaborating with the oncology community to deliver scientific breakthroughs to transform the lives of patients. Our primary focus is in lung and gastrointestinal cancers, with the goal of delivering breakthrough, first-in-class treatments that can help win the fight against cancer. Our commitment to innovation has resulted in pioneering treatments for lung cancer and we are advancing a unique pipeline of cancer cell directed agents, immune oncology therapies and intelligent combination approaches to help combat many cancers.
About Boehringer Ingelheim
Improving the health and quality of life of patients is the goal of the research-driven pharmaceutical company Boehringer Ingelheim. The focus in doing so is on diseases for which no satisfactory treatment option exists to date. The company therefore concentrates on developing innovative therapies that can extend patients’ lives. In animal health, Boehringer Ingelheim stands for advanced prevention.
Family-owned since it was established in 1885, Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies. Some 50,000 employees create value through innovation daily for the three business areas human pharmaceuticals, animal health and biopharmaceuticals. In 2017, Boehringer Ingelheim achieved net sales of nearly 18.1 billion euros. R&D expenditure, exceeding three billion euros, corresponded to 17.0 per cent of net sales.
As a family-owned company, Boehringer Ingelheim plans in generations and focuses on long-term success. The company therefore aims at organic growth from its own resources with simultaneous openness to partnerships and strategic alliances in research. In everything it does, Boehringer Ingelheim naturally adopts responsibility towards mankind and the environment.
More information about Boehringer Ingelheim can be found on www.boehringer-ingelheim.com or in our annual report: http://annualreport.boehringer-ingelheim.com.