Global real-world study assessing the benefit of sequenced targeted therapy

A real-world analysis of sequential GIOTRIF® (afatinib) and osimertinib treatment1

Head-to-head trials have demonstrated the superiority of GIOTRIF® (afatinib) vs. the 1st-line generation TKI gefitinib and osimertinib vs. the 1st-line generation TKIs gefitinib/erlotinib, as 1st-line therapy for EGFR M+ NSCLC.2,3 However, there is limited data available for understanding how to appropriately utilise both of these treatments in real-world clinical practice to maximise time on targeted therapy.

How many patients in your practice will receive targeted treatment after their 1st-line TKI?

  • In patients with common mutations, as many as 88% treated with GIOTRIF® (afatinib) will be eligible to receive a 2nd-line systemic treatment upon progression, 60% of which will receive a targeted TKI.*4
  • In line with 1st-line generation TKIs, 50-70% of patients treated with GIOTRIF® (afatinib) 1st-line may develop a T790M resistance mutation.5-7  T790M mutations have been found to be even more prevalent in Del19 vs. L858R tumours.8-12

  • Osimertinib is effective against T790M positive NSCLC, and is approved for use in this population, but resistance mechanisms are heterogeneous, poorly understood and not treatable with approved target therapies, leaving chemotherapy as the likely treatment option following resistance development.13,14

These findings suggest clinical benefit may be achieved through the employment of a sequential treatment approach, with osimertinib used as a 2nd-line therapy for the treatment of patients developing a T790M mutation on their 1st-line TKI.14

GioTag study observations of clinical outcomes in actual clinical practice aimed to assess the effectiveness of this sequential treatment approach.1

Understanding treatment sequencing in real-world clinical practice

GioTag was a global study of TKI-naïve patients receiving GIOTRIF® (afatinib) for the treatment of EGFR-mutated (Del19/L858R) advanced NSCLC who developed a T790M resistance mutation and subsequently received osimiternib.1

A diverse population of 204 patients with a broad range of ethnicities were included. At GIOTRIF® (afatinib) initiation:1

  • 15.3% had an ECOG performance status of ≥2
  • 73.5% had a Del19 mutation and 26.0% had the L858R mutation
  • 58.8% were Caucasian, 24.5% Asian, 8.8% African-American

Maximise your NSCLC EGFR M+ patients time on targeted treatment, with GIOTRIF® (afatinib) followed by osimertinib

In real-world practice, sequential GIOTRIF® (afatinib) and osimertinib provided a median 27.6 months of oral targeted therapy1


GioTag: Time on treatment with sequential GIOTRIF® and osimertinib in patients with common mutations

Estimated time on treatment probability graph for Giotrif

Adapted from Hochmair MJ et al. 2018.1


Clinical benefits were seen across patient subgroups. The effects of sequencing GIOTRIF® (afatinib) followed by osimertinib were more pronounced in patients of Asian ethnicity and patients with Del19 mutations.1

Adapted from Hochmair MJ et al. 2018.1

Initiate your patients on a treatment sequence that maximises their time on targeted therapy

At 2 years, 79% of patients treated with the sequence of GIOTRIF® (afatinib) followed by osimertinib were still alive1

GioTag: Overall survival in patients with common mutations

Graph showing Overall Survival in patients with common mutations

Adapted from Hochmair MJ et al. 2018.1

Median overall survival could not be calculated due to the limited survival period, but analysis of the data available was encouraging.

The following considerations should also be made:1

  • Patients who died on 1st-line GIOTRIF® (afatinib) were excluded from the study which introduced an immortal time bias
  • Owing to the study timelines and dates of drug approvals and availability, patients who derived long-term benefit from 1st-line GIOTRIF® (afatinib) had little chance to be enrolled in the study and may therefore have been under-represented

GIOTRIF® (afatinib) 1st-line maintenance of performance status and cerebral control* in real-world clinical practice1 

  • 75% (n=135/180) of patients maintained or improved ECOG performance status during GIOTRIF® (afatinib) treatment1

  • 6.6% (n=12/183) of patients without brain metastasis at GIOTRIF® (afatinib) initiation developed brain metastasis1

  • 38.1% (n=8/21) of patients with brain metastases at GIOTRIF® (afatinib) initiation reported no brain metastasis at the start of osimertinib therapy1


​GioTag study demonstrated the effectiveness of GIOTRIF® (afatinib) and osimertinib treatment sequencing in real-world clinical practice. Click here to see the full publication.


*In countries with universal reimbursement policies for EGFR-TKI therapies. **Patients were excluded from the trial if they had active brain metastases at the start of either GIOTRIF® or osimertinib therapy1. ECOG=Eastern Cooperative Oncology Group; EGFR M+=epidermal growth factor receptor mutation positive; NSCLC=non-small-cell lung cancer; OS=overall survival; TKI=tyrosine kinase inhibitor; ToT=time on treatment.

Study design: GioTag was a real-world, non-interventional, global study of sequential therapy with GIOTRIF® (afatinib) in 1st-line followed by osimertinib in 204 patients with EGFR M+ NSCLC (Del19/L858R). The study used existing data from medical records or electronic health records (US only). The primary outcome was time on treatment, defined from the start of the 1st-line treatment until the end of the 2nd-line treatment. The secondary objective was to collect data on acquired resistance mechanism to osimertinib.1


Hochmair MJ et al. Future Oncol. 2018; doi:10.2217/fon-2018-0711.
Park K et al. Lancet Oncol. 2016;17(5):577-589.
Soria JC et al. N Engl J Med. 2018;378(2):113-125.
Yang JC et al. Lancet Oncol. 2015;16:141-151. Supplementary material.
Hochmair M et al. Poster #73255 presented at: International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer; Yokohama, Japan; 15-18 October 2017.
Yang JC et al. J Clin Oncol. 2017;35(12):1288-1296.
Wu SG et al. Oncotarget. 2016; 7:12404-12413.
Ke EE, et al. J Thorac Oncol. 2017;12(9):1368-1375.
Matsuo N et al. Sci Rep. 2016;6:36458.
Nosaki K et al. Lung Cancer. 2016;101:1-8.
Jenkins S et al. J Thorac Oncol. 2017;12(8):1247-1256.
Lau KS et al. Ann Oncol. 2016; 27:vi416-vi454.
Osimertinib Summary of Product Characteristics, 2018.
Girard N. Future Oncol 2018;14(11):1117-1132.
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