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Boehringer Ingelheim. (10/19/18). "Press Release: Real-world Study Shows Using Giotrif/Gilotrif (afatinib) Followed by Osimertinib Provides a Median of 27.6 Months of Chemotherapy-free Time in Patients with EGFR Mutation-positive NSCLC". Ingelheim.

Organisation Organisation Boehringer Ingelheim (Group)
Products Product Giotrif®
  Product 2 osimertinib (AZD9291)
     


> GioTag is the first global, real-world study to evaluate the sequencing of targeted treatments in patients with the most common acquired treatment resistance mutation1

> Results published today in Future Oncology1


Boehringer Ingelheim today announced results from GioTag, a real-world retrospective study which examined the impact of first-line Giotrif®/Gilotrif® (afatinib) followed by osimertinib, in 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). The results showed that the sequential strategy was effective in delaying subsequent chemotherapy treatment and were published today in the journal Future Oncology.

According to the study, the median time on treatment for sequential afatinib and osimertinib was 27.6 months. In this broad, real-world population, the clinical benefit was consistent across all patient subgroups, with particularly encouraging results seen in those with exon 19 deletion (Del19)-positive disease (median time on treatment 30.3 months) and Asian patients (median time on treatment 46.7 months). Additionally, the 2 year and 2.5 year overall survival (OS) rates were 78.9% and 68.8%, respectively.1

Among the patients included in this study, 15.3% had a poor performance status at the start of afatinib treatment (as defined by ECOG performance status =2), ordinarily precluding them from clinical trials.1

While osimertinib is an effective first-line treatment,2 there is a lack of approved subsequent TKI treatment options, and many patients progress to chemotherapy following osimertinib failure.1 The results suggest that the sequential strategy of afatinib and osimertinib might offer sustained clinical benefit to a substantial number of patients, prolonging the chemotherapy-free treatment period.1

“With more targeted treatment options becoming available, it is important to understand the impact of multiple lines of targeted therapies on patient outcomes,” said Dr. Maximilian J. Hochmair, Medical Oncologist, Department of Respiratory and Critical Care Medicine, Otto Wagner Hospital and coordinating investigator in the trial. “The results of GioTag show that sequential treatment with afatinib and osimertinib is an attractive strategy in patients with EGFR mutation-positive NSCLC, offering a sustained clinical benefit to a substantial number of patients while – importantly – extending the time patients are kept off chemotherapy.”

Dr. Victoria Zazulina, Global Head of Solid Tumour Oncology, Medicine at Boehringer Ingelheim, said, “We saw through a recent global survey published at WCLC that many physicians do not feel they have enough information to make informed treatment decisions on how to make the most of the available targeted treatments for patients with EGFR M+ NSCLC; in the absence of randomised data, real-world evidence may help inform treatment decisions. GioTag is the first global study in EGFR M+ NSCLC looking at the sequencing of targeted therapies as it is used in daily clinical practice. These results will provide more insights on the use of EGFR TKIs, looking beyond first-line to maximise overall longer-term impact of targeted therapies in NSCLC.”

Results of a recent global survey of HCPs’ attitudes about sequencing treatments for EGFR M+ NSCLC patients are available here. Full results from the GioTag study will be presented at an upcoming medical conference later this year.


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 the GioTag study

About RWE


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.

References

1. MJ Hochmair et al. Sequential treatment with afatinib and osimertinib in patients with EGFR mutation-positive NSCLC: an observational study. Future Oncol. (2018) doi:10.2217/fon-2018-0711. https://www.futuremedicine.com/doi/10.2217/fon-2018-0711

2. Soria JC, Ohe Y, Vansteenkiste J, et al. Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer. N Engl J Med. 2018;378(2):113-125.

   
Record changed: 2018-11-19

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