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Demonstrating therapy effectiveness in actual clinical practice in patients like yours


                                Real-world evidence         GioTag            RealGiDo

Real-world evidence complements clinical trial data by demonstrating effectiveness in actual clinical practice in patients like yours1,2


Clinical trials are necessary for establishing comparative efficacy and safety under optimal conditions.1–3 However, results can be limited to the extent to which they can be extrapolated at the population level.2–4

Real-world evidence is required to show how generalisable clinical trial data is to the non-controlled setting of real-world clinical practice:1

  • Broad patient types that wouldn’t be eligible in clinical trials2,3
  • Without control for compliance or adherence1-3

The importance of real-world evidence is increasingly valued by regulatory authorities.1

Providing evidence of therapy effectiveness in patients like those in your practice

How real-world evidence complements clinical trial data

GioTag - the first global real-world study assessing the benefit of sequenced targeted therapy

A real-world analysis of sequential GIOTRIF® (afatinib) and osimertinib treatment5

Head-to-head trials have demonstrated the superiority of GIOTRIF®  (afatinib) vs. the 1st generation TKI gefitinib and osimertinib vs. the 1st generation TKIs gefitinib/erlotinib, as 1st-line therapy for EGFR M+ NSCLC.6,7 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.*8
  • In line with 1st generation TKIs, 50-70% of patients treated with GIOTRIF® (afatinib) 1st-line will develop a T790M resistance mutation.9-11 T790M mutations have been found to be even more prevalent in Del19 vs. L858R tumours.12-16
  • 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.17,18

 These findings suggest clinical benefit may be achieved through the employment of a sequential treatment approach, with osimertinib used as a second line therapy for the treatment of patients developing a T790M mutation on their 1st-line TKI.18

GioTag study observations of clinical outcomes in actual clinical practice aimed to assess the effectiveness of this sequential treatment approach.5


EGFR M+=epidermal growth factor receptor mutation positive; NSCLC=non-small-cell lung cancer; TKI=tyrosine kinase inhibitor.

*In countries with universal reimbursement policies for EGFR-TKI therapies.

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.5

A diverse population of 204 patients with a broad range of ethnicities were included. At GIOTRIF® (afatinib) initiation:5

  • 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


ECOG=Eastern Cooperative Oncology Group; EGFR M+=epidermal growth factor receptor mutation positive; NSCLC=non-small-cell lung cancer; TKI=tyrosine kinase inhibitor

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 therapy5

GioTag time on treatment with sequential Giotrif and osimertinib in patients diagram

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.5

GioTag ethnicity EGFR mutation table

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


EGFR M+=epidermal growth factor receptor mutation positive; NR=not reached; NSCLC=non-small-cell lung cancer; ToT=time on treatment

At 2 years, 79% of patients treated with the sequence of GIOTRIF® (afatinib) followed by osimertinib were still alive5

GioTag overall survival in patients with common mutations diagram

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

The following considerations should also be made:5

  • 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

OS = overall survival

GIOTRIF® (afatinib) 1st-line maintenance of performance status and cerebral control* in real-world clinical practice5

  • 75% (n=135/180) of patients maintained or improved ECOG performance status during GIOTRIF® (afatinib) treatment5
  • 6.6% (n=12/183) of patients without brain metastasis at GIOTRIF® (afatinib) initiation developed brain metastasis5
  • 38.1% (n=8/21) of patients with brain metastases at GIOTRIF® (afatinib) initiation reported no brain metastasis at the start of osimertinib therapy5


ECOG=Eastern Cooperative Oncology Group; EGFR=epidermal growth factor receptor; ToT=time on treatment
*Patients were excluded from the study if they had active brain metastases at the start of either GIOTRIF® (afatinib) or osimertinib therapy5

GioTag study demonstrated the effectiveness of GIOTRIF® (afatinib) and osimertinib treatment sequencing in real-world clinical practice

→ Click here to see the full publication.


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+ positive 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 first-line treatment until the end of the second-line treatment. The secondary objective was to collect data on acquired resistance mechanism to osimertinib.5

EGFR M+=epidermal growth factor receptor mutation positive; NSCLC=non-small-cell lung carcinoma

Watch GioTag study summary animation:

RealGiDo – a real-world analysis of GIOTRIF® (afatinib)​ dose modification

RealGiDo evidence complements a wealth of clinical data by demonstrating the effectiveness of GIOTRIF® (afatinib)​ dose modification in a real-world setting19

In clinical trials, individualised dosing with GIOTRIF® (afatinib) reduced the incidence and severity of AEs without compromising efficacy.20,21

RealGiDo measured the impact of dose modification on GIOTRIF® (afatinib)​​ safety and effectiveness in broad patient types treated in actual clinical practice:19

  • RealGiDo was a global study of patients receiving GIOTRIF® (afatinib) under routine care for first line treatment of EGFR-mutated (Del19/L858R) advanced NSCLC519
  • RealGiDo included patients with poor performance status (12% had ECOG 2–3)19


AE=adverse event; ECOG=Eastern Cooperative Oncology Group; NSCLC=non-small-cell lung carcinoma

In a world where no two patients are the same, GIOTRIF® (afatinib) has the flexibility of individualised dosing19-20

GIOTRIF® (afatinib) dose modification reduced ADRs incidence and severity, without compromising effectiveness, in real-world clinical practice.19


Personalised dose modification effectively reduced the incidence and severity of ADRs19

RealGiDo severity of ADRs in patients receiving dose deduction from 40mg in first 6 months

The GIOTRIF® (afatinib) safety profile was generally consistent with previous clinical trials, with no new safety signals reported.19

GIOTRIF® (afatinib) maintained consistent effectiveness regardless of dose modification19

RealGiDo time on treatment by dose received diagram

Median time on treatment was 18.7 months and consistent regardless of dose modification:19

  •  (19.5, 17.7 and 19.4 months for ≥40mg, reduced to <40 mg and initiating on ≤30 mg*, respectively; P=0.54)

RealGiDo demonstrated the effectiveness of GIOTRIF® (afatinib) dose modification in a real-world setting​

ADR=adverse drug reaction; ToT=time on treatment

*31% (n=71/228) of patients initiated GIOTRIF® (afatinib) on a dose of ≤30 mg. The recommended initiation dose for GIOTRIF® (afatinib) is 40 mg19

Study design: RealGiDo was a global, non-interventional, observational study assessing GIOTRIF® (afatinib) dose modification effectiveness as a means of reducing ADRs. Medical records of 228 patients with EGFR mutations prescribed GIOTRIF® (afatinib) 1st-line as part of routine care were assessed. Primary outcomes were to assess the effects of GIOTRIF® (afatinib) dose modification on the frequency and severity of adverse drug reactions (ADRs), time on treatment and time to progression with GIOTRIF® (afatinib) in the real-world setting and compare with data from the LUX-Lung 3 trial in a descriptive manner.19

Watch RealGiDo study summary animation:

Want to find out more about the supporting clinical trial data?

→ Read more

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  1. Khozin S et al. J Natl Cancer Inst. 2017;109(11):1-5.
  2. Roche N et al. Ann Am Thorac Soc. 2014;11Suppl2:99-104.
  3. Sherman RE et al. N Engl J Med. 2016; 375(23):2293-2297.
  4. Lakdawalla DN et al. Value Health. 2017;20(7):866-875.
  5. Hochmair MJ et al. Future Oncol. 2018; doi:10.2217/fon-2018-0711.
  6. Park K et al. Lancet Oncol. 2016;17(5):577-589.
  7. Soria JC et al. N Engl J Med. 2018;378(2):113-125.
  8. Yang JC et al. Lancet Oncol 2015;16:141–151. Supplementary material.
  9. Hochmair M et al. Poster #73255 presented at: International Association for the Study of Lung Cancer (IASLC) 18thWorld Conference on Lung Cancer; Yokohama, Japan; 15-18 October 2017.
  10. Yang JC et al. J Clin Oncol. 2017;35(12):1288-1296.
  11. Wu SG et al. Oncotarget. 2016;7:12404-12413.
  12. Ke EE, et al. J Thorac Oncol. 2017;12(9):1368-1375.
  13. Matsuo N et al. Sci Rep. 2016;6:36458.
  14. Nosaki K et al. Lung Cancer. 2016;101:1-8.
  15. Jenkins S et al. J Thorac Oncol. 2017;12(8):1247-1256.
  16. Lau KS et al. Ann Oncol. 2016;27:vi416-vi454.
  17. Osimertinib Summary of Product Characteristics, 2018.
  18. Girard N. Future Oncol 2018;14(11):1117-1132.
  19. Halmos B et al. WCLC 2018; Poster #1.01-28 presented at WCLC, Toronto, Canada; 2018.
  20. Yang JCH et al. Ann Oncol. 2016;27(11):2103-2110.
  21. Hirsh V et al. Poster #369 presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; Chicago, IL, USA; 3-7 June 2016.

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