Jeffrey S. Weber, MD, PhD, discusses the results of the phase 3 COMBI-AD trial with dabrafenib plus trametinib in patients with resected, stage III BRAF V600E/K–mutant melanoma.
Jeffrey S. Weber, MD, PhD, the deputy director of NYU Langone Health’s Perlmutter Cancer Center; Laura and Isaac Perlmutter Professor of Oncology in the Department of Medicine at NYU Grossman School of Medicine; and the 2016 Giant of Cancer Care® in Melanoma, discusses the results of the phase 3 COMBI-AD trial with dabrafenib (Tafinlar) plus trametinib (Mekinist) in patients with resected, stage III BRAF V600E/K–mutant melanoma.
The COMBI-AD trial results are impressive, with a plateau in the 5-year relapse-free survival (RFS) curve, according to Weber. After a median follow-up of 60 months, the data show a 5-year RFS of 52% for patients treated with dabrafenib plus trametinib, says Weber.
The phase 3 CheckMate-238 trial was an adjuvant trial that randomized patients with resected stage IIIB/C or stage IV melanoma to receive either nivolumab (Opdivo) or ipilimumab (Yervoy). If the results from COMBI-AD are compared with the 4-year results from the CheckMate-238 trial, the 4-year survival seen with nivolumab is the same as the 5-year survival seen with dabrafenib/trametinib, notes Weber. However, a large number of patients with stage IIIA disease included in the COMBI-AD trial did well but were not included in CheckMate-238. Additionally, patients with stage IV resected disease were included in the CheckMate-238 trial and would probably not do well with the COMBI-AD regimen, explains Weber.
Nonetheless, evidence of a plateau in the RFS curve is encouraging, according to Weber. Finally, when looking at the survival of any of the prognostic factors in the COMBI-AD trial, there appears to be a clear benefit for patients with stage IIIA-C disease, concludes Weber.