Real-world effectiveness of dabrafenib and trametinib in patients with BRAF-positive melanoma treated in routine Bulgarian clinical practice

Abstract

Malignant melanoma is among the leading forms of cancer on a global scale, accounting for 1 in 5 skin cancers. Over the past decades, the treatment of melanoma has significantly improved following the development of therapies such as MAPK molecular therapy targeted at BRAF and MEK signaling pathways. We present real-world evidence from clinical practice in Bulgaria on the treatment of malignant melanoma with dabrafenib and trametinib from 2018 to 2022. Treatment outcomes from the real-world data are compared against the pivotal clinical trials, namely COMBI-d and COMBI-v. Outcomes are compared on the basis of metrics, including overall survival, progression-free survival, and clinical benefit. Further, iterational proportional fitting is performed to control for differences in characteristics across the patient cohorts. Results show that real-world overall survival and progression-free survival outperform results from the clinical trials, particularly with respect to COMBI-d.