Real World PFS Outcomes of Bulgarian Patients With BRAF-Positive Melanoma Treated With Dabrafenib and Trametinib

OBJECTIVES:

The aim is to analyze the real world data (RWD) outcomes with respect to PFS and to compare those with the RCTs, COMBI-v and COMBI-d. The population is Bulgarian patients with BRAF-positive melanoma treated with dabrafenib and trametinib in real therapeutic practice.

METHODS:

The research is based on secondary usage of anonymized data. A retrospective analysis of electronic health records (EHRs) from hospitals was conducted. The analysis was conducted via IT Platform, which integrates large amounts of data using embedded Machine Learning and NLP algorithms. The RWD are weight-adjusted in to match the distributions of the RCTs by applying iterative proportional fitting (IPF).

Ethics committee approval or patient informed consent were not required for this type of research as per Bulgarian national regulations.

RESULTS:

The COMBI-d cohort includes 211 patients and the COMBI-v cohort includes of 352 patients. The RWD cohort consists of 190 patients who correspond to the patient characteristics of the RCTs.

The median PFS based on RWD is 16.1 (95% CI: NC-NC) months in comparison to 9.3 months from COMBI-d. The median PFS for RWD is higher than for COMBI-v at 17.0 (95% CI: NC-NC) months vs 11.4 months.

CONCLUSIONS:

The research demonstrates that Bulgarian patients with BRAF-positive melanoma treated with dabrafenib and trametinib reach equivalent and even more favourable PFS outcomes compared to RCTs COMBI-d and COMBI-v. The analysis with respect to PFS shows that the results in the real-life therapeutic practice are consistent with those in the clinical trials. Further analysis on other relative outcomes will be performed.