Real World Evidence
Real-World Evidence with GILOTRIF in 2 separate studies2,3
Results are not intended for direct comparison with clinical trials because the real-world study was an 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.
Limitations: 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.
Observational Study: Sequencing treatments with Afatinib and Osimertinib in patients with EGFR M+ mNSCLC
- A real-world, global, multicenter, restrospective, observational study of 204 adult patients with EGFR M+ NSCLC (del19/L858R)
- The study used existing data from medical records or electronic health records (US only)
- Patients had T790M-positive disease following first-line afatinib and had started on osimertinib treatment ≥10 months prior to data entry to avoid early censoring and ensure mature data
- Primary Endpoint: Median Time on Treatment defined as time from the first dose of afatinib to that of the last dose of osimertinib or death
EGFR=epidermal growth factor receptor; EGFR M+=epidermal growth factor receptor mutation positive; mNSCLC=metastatic non-small cell lung cancer; NSCLC=non-small cell lung cancer.
Primary endpoint: Median Time on Treatment was 27.6 months2
Median Time on Treatment in select patient subgroups2
Limitations: The main limitations of the study were its retrospective nature and potential for selection bias. Sites that had experience prescribing afatinib and managing adverse events regularly were included in the study, however, enrollment was capped at 15 patients per site.
Impact of afatinib dose modification on safety and effectiveness in patients with EGFR mutation-positive advanced NSCLC: results from a global real-world study (RealGiDo)3
- A non-interventional, observational, global, retrospective study conducted in 228 patients enrolled from 13 countries treated with GILOTRIF tablets
- Sites were included based on the commercial availability of afatinib prior to January 1, 2015 and the use of afatinib having been adopted as routine care for patients with EGFR mutations
- Medical records of consecutive patients who met the following criteria were reviewed: aged ≥18 years with EGFR-mutated (del19/L858R), TKI-naïve, advanced NSCLC who were treated with first-line afatinib within the approved label and provided written informed consent where required
- Inclusion was also restricted to patients with treatment initiation ≥6 months prior to enrollment
- Patients were excluded if they had any contraindications to afatinib based on the label, had NSCLC with uncommon mutations, or had been treated within a clinical trial
Primary safety and efficacy outcomes
- Percentage of patients with adverse drug reactions (ADRs) by severity
- Time to treatment failure; synonymous with time on treatment
- Time to progression
- Percentage of patients with a starting dose modification
- Reasons for a starting dose modification
GILOTRIF starting dose3
*Although assessed as part of a global study, not all are approved doses in the US.
Real-World Evidence reinforces that GILOTRIF Dose Adjustments may reduce the frequency and intensity of Adverse Reactions without compromising effectiveness3
Common adverse drug reactions (> 10% incidence) pre- and post-dose reduction within the first 6 months after starting on afatinib 40mg/day (N=91)3
Median time to treatment failure & progression in RealGiDo3
‡Time to treatment failure is defined as the time from the first dose of afatinib to the last dose of afatinib. Time to progression is defined as the time from the first dose of afatinib to the earliest occurrence of documented progression or death.
These results suggest afatinib was an effective 1st-line treatment for patients with EGFR M+ mNSCLC and that tailoring the afatinib dose based on individual patient characteristics can reduce the frequency and intensity of ADRs without compromising effectiveness3