July 2025, Expert Review of Pharmacoeconomics & Outcomes Research, an esteemed peer-reviewed journal published by Taylor & Francis Group, released the article titled “Real-world evidence of first-line Osimertinib effectiveness in Bulgarian patients: a retrospective analysis.”

This impactful Real-World Evidence (RWE) study, co-authored by the National Council on Prices and Reimbursement of Medicinal Products, prominent Bulgarian healthcare professionals, and Sqilline Health, provides critical insights into the real-world performance of a third-generation EGFR tyrosine kinase inhibitor (EGFR-TKI) as a first-line therapy for patients with EGFR-mutated non-small-cell lung cancer (NSCLC) in Bulgaria.

Sqilline’s Danny Platform played a key role in transforming unstructured clinical data from Bulgarian hospitals into research-ready datasets. The platform supported comprehensive survival analyses and patient matching with clinical trial populations, enabling this high-quality publication.

Introduction

Lung cancer remains the leading cause of cancer-related death globally, with NSCLC accounting for 85% of all lung cancer cases. A third-generation EGFR-TKI, has shown superior results in clinical trials like FLAURA. This retrospective study examines whether those benefits translate into real-world outcomes in Bulgaria, using data from 2019 to 2023, 4 years.

Key Summary Points

Objectives

• To assess the real-world effectiveness of first-line Osimertinib in Bulgarian patients with EGFR-mutated NSCLC.
• To compare real-world outcomes with those from the FLAURA clinical trial, including PFS (progression-free survival), ORR (objective response rate), and CBR (clinical benefit rate).

Challenges

• Incomplete or fragmented EHR data required robust tools for processing and analysis.
• Differences in patient characteristics between real-world populations and clinical trial cohorts introduced potential bias.
• Limited national infrastructure for centralized oncology outcomes data, making structured RWE generation difficult.

Solution

Danny Platform addressed these challenges by:

• Incomplete or fragmented EHR data required robust tools for processing and analysis.
• Differences in patient characteristics between real-world populations and clinical trial cohorts introduced potential bias.
• Limited national infrastructure for centralized oncology outcomes data, making structured RWE generation difficult.

Results

Patient Demographics

• Among 10,275 diagnosed NSCLC patients, 619 (13.7%) had EGFR mutations.
• 365 patients received first-line third-generation EGFR-TKI; 64% were female, with a mean age of 66.9 years.
• 20% had CNS metastases.

Clinical Outcomes

• PFS (Progression-Free Survival):1 months (RWE) vs. 18.9 months (FLAURA).
• ORR (Objective Response Rate): 26% (RWE) vs. 14% (FLAURA).
• CBR (Clinical Benefit Rate): 89% (RWE) vs. 94% (FLAURA).
• Partial responses were more frequent in the real world (24% vs. 13%).
• RWE cohort maintained longer disease control beyond 18 months compared to the clinical trial.
• RWE closely aligns with FLAURA results, suggesting even greater benefit of first-line Osimertinib in the real-world setting.

Post-Progression Treatment

• Only 9% of patients progressed on first-line third-generation EGFR-TKI during the study.
• Most common second-line therapies: atezolizumab (alone or in combinations), pembrolizumab, afatinib.

Benefits

• Validated third-generation EGFR-TKI’s real-world efficacy and supported its integration into standard NSCLC care.
• Highlighted Danny Platform’s value in structuring fragmented oncology data into actionable insights.
• Informed national policy and clinical practice, reinforcing the utility of RWE in regulatory and reimbursement decisions.

Authors and Affiliations

Manoela Manova, Boryana Ivanova, Alexandra Savova
Medical University – Sofia & National Council on Prices and Reimbursement of Medicinal Products (NCPRMP), Bulgaria

Jeliazko Arabadjiev
Medical Oncology, University Hospital Acibadem City Clinic Tokuda, Sofia, Bulgaria

Assen Dudov
Acibadem City Clinic Mladost Hospital, Sofia, Bulgaria

Radoslav Mangaldzhiev
Specialized Oncology Hospital, Sofia, Bulgaria

Daniel Penchev, Zornitsa Katrandzhieva
Sqilline Health, Sofia, Bulgaria

Lyubomir Bakalivanov
National Cardiology Hospital & NCPRMP, Bulgaria

Boryana Zidarova, Dimitrina Apostolova, Mariya Vasileva, Silvia Terezova
NCPRMP & University of National and World Economy (UNWE), Sofia, Bulgaria

👉 Click here to read the full publication in Expert Review of Pharmacoeconomics & Outcomes Research