Dr. Funchain on the Rationale for the SWOG S1404 Trial in Melanoma

Pauline Funchain, MD, medical oncologist, Department of Hematology and Medical Oncology, Cleveland Clinic, discusses the rationale for the phase 3 SWOG S1404 trial (NCT02506153) in high-risk resected melanoma.

The SWOG S1404 trial was developed when no options were available for the adjuvant treatment of patients with melanoma, Funchain explains. The hypothesis that led to the study was that since immunotherapy has utility in the metastatic setting for patients with melanoma, perhaps it is efficacious in the post-resection setting. 

Other clinical trials were evaluating the same hypothesis with different drugs and comparator arms; however, the SWOG S1404 trial incorporated overall survival (OS) as its primary end point, Funchain says. The results of the study were meant to provide insight into the utility of immunotherapy for this patient population beyond recurrence-free survival (RFS), Funchain says.

As such, the results of the final analysis of the study, which were presented during the 2021 ASCO Annual Meeting, showed that 1 year of adjuvant pembrolizumab (Keytruda) significantly improved RFS, but not OS, compared with high-dose interferon or ipilimumab (Yervoy) in patients with high-risk resected melanoma.