In a retrospective multicenter study, adjuvant dabrafenib plus trametinib demonstrated superior recurrence-free survival (RFS) and distant-metastasis-free survival (DMFS) compared to observation or anti-PD-1 therapy in patients with stage IIIA cutaneous melanoma. Published in Annals of Oncology, the analysis included 628 patients treated between 2018 and 2021 across Australia, Europe, and the U.S., with groups receiving either observation (n=292), anti-PD-1 inhibitors (n=256), or dabrafenib-trametinib (n=80).
At a median follow-up of ~2.5 years, the 2-year RFS was highest in the dabrafenib-trametinib group (98.6%) versus observation (84.3%) and anti-PD-1 (79.3%) groups (P < .0001). DMFS was also significantly improved in the dabrafenib-trametinib group (100%) compared to observation (91.1%) and anti-PD-1 (88.4%) (P = .005). No new safety signals were noted, though grade ≥3 treatment-related adverse events were more frequent in the dabrafenib-trametinib group (17.5%) versus the anti-PD-1 group (10.9%).
While the findings suggest promise, the authors caution that the study’s retrospective design and lack of events in the dabrafenib-trametinib arm limit definitive conclusions. Larger, prospective trials are needed to validate the benefit of BRAF-targeted adjuvant therapy in stage IIIA melanoma.