Boehringer Ingelheim has initiated GioTag, a real-world study to assess the impact of sequential therapy in patients with EGFR mutation-positive 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 analyzed to determine total time on treatment.
"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,” Dr. Maximilian Hochmair, medical oncologist in Vienna and coordinating investigator in this trial, said. “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 analyze data from 65 study centers in 11 countries to determine the time on treatment of afatinib as first-line therapy in EGFR mutation positive 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 mutation positive NSCLC.
Results from GioTag are expected to be available in 2018.
Afatinib is approved in the US under the brand name Gilotrif and in a number of markets, including the EU, Japan, China, Taiwan and Canada under the brand name Giotrif 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.