Interim update of the GioTag real-world study: survival data
The GioTag study is a retrospective, observational, global real-world study assessing the benefit of afatinib followed by osimertinib in patients with EGFR M+ NSCLC.1* At the initial database lock in May 2018, 63 patients had died (30.9%) and OS analysis was immature.1 The interim analysis of updated data from the GioTag study has been conducted which assessed median OS and updated median time on treatment.1
Afatinib followed by osimertinib was associated with encouraging OS in patients with EGFR M+ NSCLC and was particularly promising in patients with a Del19 mutation.1
Read the original publication: the interim update of the GioTag study
Study Design
For the interim updated analysis, data were collected from 94 patients with electronic health records (all from the USA)1
- At the time of database lock (April 2019), 85 patients had died, 26 were lost to follow-up, 92 were still alive and 63 remained on osimertinib1
Final analysis, incorporating data from manual chart reviews of a further 29 patients is anticipated in early 2020 – including those in the Asian subgroup who showed encouraging results in the initial analysis.1
OS
In the overall population (patients with common mutations), median OS was 41.3 months (42% maturity)1*†‡
GioTag study interim update: OS in patients with common mutations1*†‡
In patients with a Del19 mutation, median OS was almost 4 years (45.7 months)1*†
GioTag study interim update: OS in patients with a Del19 mutation1*†
Updated TTF (afatinib followed by osimertinib)
In the overall population (patients with common mutations), updated median TTF was 28.1 months1
GioTag study interim update: TTF in patients with common mutations1*†‡
In patients with a Del19 mutation, median TTF was 30.6 months1
GioTag study interim update: TTF in patients with a Del19 mutation1*†
* TTF (Time to treatment failure)
CI=confidence interval; Del19=deletion 19; EGFR M+=epidermal growth factor receptor mutation positive; NSCLC=non-small cell lung cancer; OS=overall survival. TTF= Time to treatment failure
*Patients who acquire a T790M mutation on progression with GIOTRIF®.
†Interim update analysis performed in April 2019 using data from 94 patients with electronic health record data (all from USA). The 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.1,2
‡At the start of treatment with GIOTRIF®, 73.5% of patients had a Del19 mutation.
References
- 1
- Hochmair MJ, et al. Future Oncol 2019. In press.
- 2
- Hochmair MJ, et al. Future Oncol 2018;14:2861–2874.
