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Georgina Long, MBBS, PhD, FRACP, discusses unmet needs for BRAF-mutant melanoma, highlighting key insights from the phase 3 NADINA trial.
Georgina V. Long, MBBS, PhD, FRACP, co-medical director, Melanoma Institute Australia (MIA), and chair, Melanoma Medical Oncology and Translational Research, MIA and Royal North Shore Hospital, The University of Sydney, discusses the remaining unmet needs for patients with BRAF-mutant melanoma and how data from the phase 3 NADINA trial (NCT04949113) could help address some of these needs.
Despite advancements in adjuvant and metastatic treatment settings, significant challenges remain for patients with BRAF-mutant melanoma, Long notes. She explains that more than half of patients who receive adjuvant combination therapy with dabrafenib (Tafinlar) and trametinib (Trametinib) experience recurrence. Additionally, approximately half of patients with metastatic BRAF-mutated melanoma will ultimately die of their disease, Long continues. These statistics underscore the critical need for improved therapeutic strategies for this patient population, Long says.
Findings from the NADINA trial were presented by Christian U. Blank, MD, PhD, of the Netherlands Cancer Institute at the 2024 ASCO Annual Meeting. The trial investigated the efficacy of neoadjuvant combination therapy with nivolumab (Opdivo) plus ipilimumab (Yervoy), followed by adjuvant nivolumab with or without radiotherapy, compared with adjuvant nivolumab with or without radiotherapy in patients with stage III de novo or recurrent resectable melanoma with a least 1 lymph node metastasis. Notably, the trial enrolled patients with BRAF-mutated or BRAF wild-type disease.
Data showed that patients in the experimental arm (n = 212) experienced a 68% reduction in the risk of recurrence, progression, or death vs those in the control arm (HR, 0.32; 99.9% CI, 0.15-0.66; P < .0001). The 1-year event-free survival (EFS) rates were 83.7% for the neoadjuvant arm vs 57.2% for the adjuvant arm.
In patients with BRAF-mutated melanoma, the risk of recurrence, progression, or death was reduced by 71% for the neoadjuvant regimen vs the adjuvant regimen (HR, 0.29; 99.9% CI, 0.11-0.79; P < .0001). Patients with BRAF-mutated disease treated in the neoadjuvant setting (n = 112) experienced a 1-year EFS rate of 83.5% vs 52.2% for those treated in the adjuvant setting alone (n = 112).