Randomized phase 2 study of sequential immunotherapy and targeted therapy for untreated BRAF-mutated metastatic melanoma

Limited prospective data are available on sequential immunotherapy and BRAF/MEK inhibition for BRAFV600-mutant metastatic melanoma. The randomized phase 2 SECOMBIT trial, at 37 centers in 9 countries, included patients with previously untreated BRAFV600-mutant metastatic melanoma, and randomized them to targeted therapy first till progression followed by immunotherapy, or immunotherapy first till progression followed by targeted therapy, or sandwich treatment with 8 weeks of targeted therapy followed by immunotherapy till progression followed by targeted therapy. Assuming a null hypothesis of median OS of ≤ 15 months, the OS endpoint was met for all arms. The authors conclude that sequential immunotherapy and targeted therapy provide clinically meaningful survival benefits for patients with BRAFV600-mutant metastatic melanoma.