Phase III GioTag study with Gilotrif in NSCLC published in Future Oncology.- Boehringer.

Boehringer announced results from GioTag, a real-world retrospective, observational study, which assessed total treatment duration of first-line 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). The results suggest that this sequential strategy may prolong the chemotherapy-free treatment period in the real-world patient population studied and were published 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 of 204 patients, the clinical results were 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). Among the patients included in this study, 15.2% had a poor performance status at the start of afatinib treatment (as defined by ECOG performance status of at least 2), ordinarily precluding them from clinical trials. Although not a primary objective of the study, and not mature at the time of analysis, the 2 year and 2.5 year overall survival (OS) rates were 78.9% and 68.8%, respectively.

See: "Sequential treatment with afatinib and osimertinib in patients with EGFR mutation-positive non-small-cell lung cancer: an observational study" Maximilian J Hochmair et al. Future Oncology Ahead of Print 19 Oct 2018 https://doi.org/10.2217/fon-2018-0711