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Real-world evidence of first-line osimertinib effectiveness in Bulgarian patients: a retrospective analysis
Manoela Manova1,2, Boryana Ivanova1,2, Jeliazko Arabadjiev3
1Department of Organization and Economy of Pharmacy, Faculty of Pharmacy, Medical University, Sofia, Bulgaria.
Background:
Third-generation EGFR tyrosine kinase inhibitor (EGFR-TKI) osimertinib is approved as a first-line treatment against non-small-cell lung cancer (NSCLC) harboring sensitizing EGFR mutations. Herein, we perform a retrospective analysis of real-world data on first-line osimertinib treatment among Bulgarian patients with NSCLC, comparing treatment outcomes to FLAURA results.
Research Design And Methods:
Patient data were obtained from electronic health records over a 4-year period. Baseline characteristics and endpoints (progression-free survival [PFS], objective response rate [ORR], and clinical benefit rate [CBR]) were compared. Iterative proportional fitting was performed to balance patient characteristics prior to survival analysis.
Results:
A total of 365 patients on first-line osimertinib were included. Partial responses were more frequent in the RWE cohort (24% vs 13%), while the opposite was noted for stable disease (63% vs 80%). Complete response frequency was comparable (2% vs 1%). The ORR was higher in the real world compared to in FLAURA (26% vs 14%), whereas CBR was slightly higher in the trial (89% vs 94%). The real-world PFS was higher than reported in FLAURA (19.1 vs 18.9 months), with more favorable outcomes in the RWE cohort beyond 18 months.
Conclusion:
RWE closely aligns with FLAURA results, suggesting even greater benefit of first-line osimertinib in the real-world setting.
Insights
First-line osimertinib in non-small-cell lung cancer (NSCLC) shows comparable outcomes in Bulgarian real-world data (RWD) versus the FLAURA trial. Real-world progression-free survival was slightly higher, suggesting potential for greater benefit.
Area of Science:
- Oncology
- Pharmacology
- Clinical Research
Background:
- Osimertinib, a third-generation EGFR tyrosine kinase inhibitor (EGFR-TKI), is a standard first-line treatment for EGFR-mutated non-small-cell lung cancer (NSCLC).
- Real-world data (RWD) analysis is crucial to validate clinical trial findings in diverse patient populations.
Purpose of the Study:
- To retrospectively analyze real-world outcomes of first-line osimertinib in Bulgarian NSCLC patients.
- To compare these real-world outcomes with those reported in the pivotal FLAURA clinical trial.
Main Methods:
- Retrospective analysis of electronic health records for 365 patients receiving first-line osimertinib.
- Comparison of baseline characteristics and key endpoints: progression-free survival (PFS), objective response rate (ORR), and clinical benefit rate (CBR).
- Statistical methods including iterative proportional fitting for balancing patient characteristics prior to survival analysis.
Main Results:
- The real-world cohort showed a higher objective response rate (ORR) (26% vs 14%) and partial response frequency (24% vs 13%) compared to FLAURA.
- Progression-free survival (PFS) in the real-world setting was slightly higher (19.1 vs 18.9 months).
- Clinical benefit rate (CBR) was comparable, with slightly higher rates in the FLAURA trial (94% vs 89%).
Conclusions:
- Real-world evidence (RWE) for first-line osimertinib in NSCLC closely aligns with FLAURA trial results.
- The findings suggest that first-line osimertinib may offer even greater benefits in the real-world setting.
- This study validates the efficacy of osimertinib in a specific real-world population and supports its continued use.
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