34 Initial results demonstrated immunogenicity of both vaccines but showed no significant survival differences between study arms 34 ; however, post-hoc analysis of long-term clinical outcomes revealed significantly improved OS and a favorable trend to improved RFS with melanoma-cognate helper peptide vaccination, with greatest benefit in males (Table 2 ). 35 These results provide support for designing a randomized phase III trial with melanoma helper peptide vaccination powered to detect differences in clinical outcome and highlights the need to study the impact of biologic sex on outcomes in vaccine trials.
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The reported outcomes favored the addition of the vaccine, with significantly improved overall clinical response rates and progression-free survival (PFS) and a strong trend to prolonged OS (Table 1 ). 16 While these data supported clinical benefit of vaccine targeting a TAA, results from another trial testing combination immune checkpoint inhibitor (ICI) therapy with a similar gp100 vaccine did not demonstrate a clinical benefit from the addition of vaccine.