• Sequential afatinib and osimertinib was associated with encouraging time on treatment and overall survival in patients with EGFR T790M-positive NSCLC, especially in patients with Del19 mutation

• Updated analysis of the observational GioTag study is published today in Future Oncology

INGELHEIM, Germany -- (BUSINESS WIRE) --

Boehringer Ingelheim today announced updated, interim analysis results from the GioTag study, showing that initiating treatment with afatinib followed by osimertinib provided an overall survival (OS) of almost four years (45.7 months) in patients with Del19-positive tumours.[i] The GioTag study is a real-world retrospective, observational and unblinded study which examined the impact of treatment with 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 GioTag study previously provided only 2 years and 2.5 years OS rates. Now, a subsequent analysis assessed updated data from a sub-set of patients with available electronic health records (from the U.S). The use of electronic data, which facilitated rapid analysis, represented the first step of a two-stage process. After a median follow-up of 30.3 months, median overall survival was almost three and a half years (41.3 months) in patients with acquired EGFR T790M-positive NSCLC treated in a real-world clinical setting, and the updated two-year OS rate was 80%.ⁱ

OS is particularly promising in patients with Del19-positive tumours at the onset of afatinib treatment. In these patients, median OS was 45.7 months and the two-year OS rate was 82%. Updated median time on treatment for sequential afatinib and osimertinib was 28.1 months overall, and 30.6 months in patients with Del19-positive tumours. Median time on osimertinib treatment following treatment with afatinib was 15.6 months and 16.4 month for Del19 mutations.ⁱ

Dr. Maximilian J. Hochmair, Medical Pulmonologist, Department of Internal Medicine and Pneumology, Krankenhaus Nord, Klinik Floridsdorf and coordinating investigator in the study said, “As many patients with this type of lung cancer eventually acquire resistance to EGFR TKIs, it’s important to consider the order of these therapies to provide patients with as many future treatment options as possible. The updated GioTag study findings provide supportive evidence that afatinib followed by osimertinib is a viable treatment sequence option for patients with EGFR M+ NSCLC.”

Dr. Victoria Zazulina, Corporate Vice President and Global Head of Oncology, Medicine, at Boehringer Ingelheim, said, “The continued clinical development of new EGFR TKIs provides additional treatment options for patients with EGFR M+ NSCLC, and raises questions about their optimal sequence. Given that, as yet, no established targeted treatment options are available following failure of osimertinib, there is an argument for reserving osimertinib for second-line use after second-generation EGFR TKIs. Real-world data from the GioTag study supports the argument for sequential use of afatinib and osimertinib for patients with EGFR M+ NSCLC who are Del19-positive.”

The observational GioTag study provides data on a broad, real-world population of patients. 15.3% had a poor performance status of ECOG PS of ≥2 and 10.3% had stable brain metastases, ordinarily criteria which would preclude these patients from participation in clinical trials. More on the observational GioTag study can be found here. This interim analysis is the first of a two-step process. A final analysis is planned for early 2020 which will include updated data from Asian and European countries.

Footnote:

* 73.5% of patients had a Del19 mutation, and 26.5% a L858R mutationⁱ

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