Final analysis of the observational GioTag study: Sequential afatinib and osimertinib in patients with EGFR mutation-positive non-small cell lung cancer
RIDGEFIELD, Conn., Sept. 2, 2020 /PRNewswire/ -- 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 Gilotrif® (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) of 27.7 months (90% CI: 26.7–29.9).
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."
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. 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).
Clinical effectiveness was also consistent across patient subgroups which are sometimes unexamined in prospective randomized clinical trials due to poor prognosis characteristics. 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. 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.
Bjoern Rueter, M.D., Therapeutic Area Head Oncology, USA, at Boehringer Ingelheim, said, "Resistance to first-line EGFR TKI therapy is an inevitability, making subsequent treatment options following disease progression a key consideration. While no prospective overall survival data are currently available to compare different sequential regimens of EGFR TKIs, the final GioTag study data provide important insight into the use of afatinib followed by osimertinib. The GioTag data suggest a potential for prolonged periods of time on non-chemotherapy treatment in patients with EGFR Del19 who develop T790M mutation-positive tumors."
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.
What Is Gilotrif?
Gilotrif is a prescription medicine that is used to treat people with non-small cell lung cancer (NSCLC) that:
It is not known if Gilotrif is safe and effective in treating people with lung cancer that has resistant abnormal EGFR genes.
is used to treat people with squamous cell lung cancer that:
It is not known if Gilotrif is safe and effective in children.
Important Safety Information for Gilotrif® (afatinib) Tablets
Before you take Gilotrif, tell your doctor if you:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Gilotrif may affect the way other medicines work, and other medicines may affect the way Gilotrif works. Taking certain medicines with Gilotrif may increase your risk of developing a tear (perforation) in your stomach or intestine.
What to avoid while taking Gilotrif
Gilotrif may cause serious side effects, including:
Your doctor will do blood tests to check your liver function during your treatment with Gilotrif.
Get medical help right away if you develop severe stomach-area (abdomen) pain during treatment with Gilotrif.
Your doctor may change your dose, temporarily stop or permanently stop treatment with Gilotrif if you have certain side effects.
The most common side effects of Gilotrif include diarrhea, rash, acne, mouth sores, nail inflammation, dry skin, decreased appetite, nausea, vomiting, and itching.
Gilotrif may cause decreased fertility in females and males. This may affect your ability to have a child. Talk to your doctor if this is a concern for you.
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of Gilotrif. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
GF CONS ISI 10.21.19
About Boehringer Ingelheim in Oncology
About Boehringer Ingelheim Pharmaceuticals, Inc.
As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of around $21.3 billion (19 billion euros). Our significant investment of over $3.9 billion (3.5 billion euros) in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life. In 2018, Boehringer Ingelheim achieved net sales of around $20.7 billion (17.5 billion euros). R&D expenditure of almost $3.7 billion (3.2 billion euros) corresponded to 18.1 per cent of net sales.
We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation and is part of the Boehringer Ingelheim group of companies. In addition, there are Boehringer Ingelheim Animal Health in Duluth, GA and Boehringer Ingelheim Fremont, Inc. in Fremont, CA.
Boehringer Ingelheim is committed to improving lives and strengthening our communities. Please visit www.boehringer-ingelheim.us/csr to learn more about Corporate Social Responsibility initiatives.
For more information, please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS.
Boehringer Ingelheim Pharmaceuticals, Inc.
View original content to download multimedia:http://www.prnewswire.com/news-releases/final-analysis-of-the-observational-giotag-study-sequential-afatinib-and-osimertinib-in-patients-with-egfr-mutation-positive-non-small-cell-lung-cancer-301122531.html
SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.