GSK reports improved survival outcomes in Phase III melanoma study
Final results from the COMBI-d trial show that the combination of dabrafenib and trametinib reduces the risk of death in patients with BRAF V600-mutated metastatic melanoma.
GSK has released final overall survival data from its Phase III COMBI-d study, demonstrating that the combination therapy of dabrafenib (Tafinlar) and trametinib (Mekinist) provides a significant survival benefit compared to dabrafenib monotherapy. The study focused on patients with BRAF V600E/K mutation-positive metastatic melanoma, showing a hazard ratio of 0.71.
The trial, which randomized 423 patients across international sites, reinforces the clinical rationale for combining BRAF and MEK inhibitors. Patrick Vallance, President of Pharmaceuticals R&D at GSK, noted that the findings further substantiate the potential of this therapeutic combination. Completion of this study fulfills a post-marketing regulatory requirement established during the drug's initial accelerated approval process in the United States.
Regarding safety, the profile remained consistent with previous observations, with no new clinical concerns identified. Common adverse events included pyrexia, fatigue, and headache, which were managed through dose adjustments. The final dataset is scheduled for submission to regulatory authorities in the coming months.