OS in patients with a del19 mutation 1*
Final analysis of the real-world GioTag study: survival and time to treatment failure data
The GioTag study is a global, real-world, retrospective, observational, unblinded study that assessed the impact of 1st-line treatment with afatinib followed by osimertinib in patients with EGFR M+ NSCLC who acquired a T790M mutation on afatinib progression.1
The study was conducted across 10 countries, with patients enrolled between December 2017 and May 2018.1,2
Data were collected between December 2017 and December 2019. Data were sourced either from sites directly approached by Boehringer Ingelheim (n=77; 38%) or from electronic health records (n=126; 62%).1
Final TTF and OS analyses of patients in the GioTag study have now been conducted.1
Final results indicate that afatinib followed by osimertinib was an effective therapeutic strategy in a broad, real-world population of patients with EGFR M+ NSCLC,* with encouraging results in patients with a Del19 mutation and patients of Asian ethnicity1
- To limit selection bias each participating centre assessed the health records of a maximum of 15 consecutive patients1
- All patients must have initiated osimertinib ≥10 months prior to enrolment to avoid early censoring and ensure mature data1
- Data cut-off for the final analysis was 28 November 2019. Data for all enrolled patients were included, apart from 1 patient who was excluded due to reports of conflicting data1
For the final analysis, data were collected from 203 EGFR-TKI-naïve patients with T790 Macquired resistance, including 149 patients with a Del19 mutation and 50 patients of Asian ethnicity.1
- At baseline, 10% of patients had CNS metastases and 15% of patients had ECOG performance status ≥21
This final analysis represents the most mature analysis to date of OS with sequential afatinib and osimertinib.1 Data for the overall population are 59% mature and data for patients of Asian ethnicity are 50% mature.3
Patients with a Del19 mutation
In patients with a Del19 mutation, median OS was 3.5 years
- In the overall population, median OS was 37.6 months (90% CI: 35.5–41.3) and TTF was 27.7 months
(90% CI: 26.7–29.9)1*†
Patients of Asian ethnicity
In patients of Asian ethnicity, median OS was over 3.5 years
(44.8 months; 50% maturity)1,3*
OS in patients of Asian ethnicity 1*
- In patients of Asian ethnicity with a Del19 mutation (n=31), median OS was 45.7 months (90% CI: 38.2–57.8) and TTF was 40.0 months (90% CI: 36.4–45.0)1*
Limitations of the GioTag study
1. Real-world evidence has the potential to complement clinical trial data and may help to support treatment decisions based upon outcomes from clinical practice4
2. Real-world evidence has limitations4
- Real-world studies are often retrospective in nature and results may be impacted by confounding factors4
3. Results from the GioTag study may be impacted by limitations of the study design
- The main limitations were its retrospective nature and potential for selection bias1
- The other main limitation was a lack of a comparator arm, which limits interpretation of the results1
- Patients who died on 1st-line afatinib were excluded from the study, which introduced an immortal time bias2
- Owing to the study timelines and dates of drug approvals and availability, patients who derived long-term benefit from 1st-line afatinib had little chance of being enrolled in the study and may therefore have been under-represented2
Results are not intended for direct comparison with prospective clinical trials because the real-world study was a retrospective, observational trial with no comparator arm. Differences in study designs, patient populations, definitions of safety or efficacy outcomes, as well as data collection methods, make it difficult to compare real-world studies with clinical trials.
*Patients who acquire a T790M mutation on progression with afatinib.
CNS=central nervous system; CI=confidence interval; Del19=deletion 19; ECOG=Eastern Cooperative Oncology Group; EGFR=epidermal growth factor receptor; EGFR M+=epidermal growth factor receptor mutation positive; NSCLC=non-small cell lung cancer; OS=overall survival; TKI=tyrosine kinase inhibitor; TTF=time to treatment failure.
†At the start of treatment with afatinib, 73.5% of patients had a Del19 mutation.
- Hochmair MJ, et al. Future Oncol 2020. DOI: 10.2217/fon-2020-0740.
- Hochmair MJ, et al. Future Oncol 2018;14:2861–2874.
- Boehringer Ingelheim. Data on file.
- Sherman RE, et al. N Engl J Med 2016;375:2293–2297.