Final analysis of the observational GioTag study: Sequential afatinib and osimertinib in patients with EGFR mutation-positive non-small-cell lung cancer

 

Ingelheim, Germany, 2nd September 2020 – Boehringer Ingelheim today announced the final analysis from GioTag, a real-world retrospective, observational study.  The study assessed the impact of first-line treatment with afatinib followed by osimertinib in Del19/L858R epidermal growth factor receptor mutation positive (EGFR M+) non-small cell lung cancer (NSCLC) patients with acquired T790M mutations, the most common mechanism of resistance to first-and second-generation EGFR tyrosine kinase inhibitors (TKIs).  Results showed that across the 203 patients included in the analysis, sequential treatment of afatinib followed by osimertinib provided a median overall survival (OS) of 37.6 months (90% confidence interval (CI): 35.5–41.3) and median Time to Treatment Failure  (TTF, combined treatment duration on sequential TKIs) of 27.7 months (90% CI: 26.7–29.9).ⁱ

 

Results showed that Asian and Del19-positive patients saw a median OS of 44.8 months (90% CI: 37.0–57.8) and 41.6 months (90% CI: 36.9–45.0) respectively.  Median TTF was 37.1 months (90% CI: 28.1–40.3) and 30.0 months (90% CI: 27.6–31.9) for these groups, respectively.ⁱ In the 31 Asian patients with Del19-positive disease, median OS was 45.7 months (90% CI: 38.2–57.8) and TTF was 40.0 months (90% CI: 36.4–45.0).ⁱ  The TTF observed here suggests that the GioTag treatment strategy could potentially allow these particular patient sub-groups to receive additional long-term, chemotherapy-free treatment.

 

Clinical effectiveness was also consistent across patient subgroups which are sometimes excluded from or under-represented in randomized clinical trials. For these subgroups, median OS was 31 months (90% CI: 19.5–45.0) in patients with stable brain metastases, 36.9 months (90% CI: 33.0–44.8) in patients aged ≥65 years, and 32 months (90% CI: 24.5–34.5) in those with ECOG PS ≥2.ⁱ  TTF for these groups was 22.2 months (90% CI: 16.8–29.9), 27.3 months (90% CI: 20.4-31.3) and 22.2 months (90% CI: 16.0–26.5), respectively.ⁱ

 

Dr. Maximilian J. Hochmair, Medical Oncologist, Department of Respiratory and Critical Care Medicine, Karl Landsteiner Institute and coordinating investigator of the GioTag study said, “The real-world data reported here represent the most mature analysis of OS with sequential afatinib and osimertinib to date. The final GioTag results support the results of our previous analyses, that sequential afatinib and osimertinib treatment could be a feasible and effective therapeutic strategy in a broad, real-world population of patients with EGFR M+ NSCLC who acquire T790M.”

 

Dr. Victoria Zazulina, Corporate Vice President and Global Head of Oncology, Medicine, at Boehringer Ingelheim said, “Treatment options beyond progression on the first-line targeted therapy are a key consideration towards extending a chemotherapy-free time for patients with EGFR mutation positive NSCLC. With this aim, the final GioTag data supports the use of sequential treatment with afatinib followed by osimertinib, particularly for Asian group and patients with DEL19 subtype of EGFR mutation.” 

 

 

GioTag was a real-world retrospective, observational study which assessed the impact of first-line treatment with afatinib followed by osimertinib in Del19/L858R EGFR M+ non-small cell lung cancer patients with acquired T790M mutations, the most common mechanism of resistance to first- and second-generation EGFR tyrosine kinase inhibitors (TKIs).  The study was conducted across ten countries: Austria, Canada, Israel, Italy, Japan, Singapore, Slovenia, Spain, Taiwan and USA; NCT03370770.  Data were collected between December 2017 and December 2019.  Inclusion was restricted to patients who initiated osimertinib treatment ≥10 months prior to enrolment to avoid early censoring and ensure mature data. A maximum of 15 patients were enrolled per site. Data were sourced either from sites directly approached by Boehringer Ingelheim (n = 77; 38%) or from electronic health records (n = 126; 62%) supplied by Cardinal Health (OH, USA). For quality assurance of the documented patient observations, source data verification was performed on approximately 30% of included patients.  Main limitations of this study were its retrospective nature and potential for selection bias. The other main limitation of the study was a lack of a comparator arm, which limits interpretation of the results.

 

Cancer takes. Takes away time. Takes away loved ones. At Boehringer Ingelheim Oncology, we are giving patients new hope, by taking cancer on.  We are dedicated to collaborating with the oncology community on a shared journey to deliver leading science. 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.

 

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