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Long-Term Outcomes of Helper Peptide Vaccination for Metastatic Melanoma
Yinin Hu*, Helen Kim*, Christopher M Blackwell*, Mark E Smolkin*, Craig L Slingluff, Jr.
University of Virginia School of Medicine, Charlottesville, VA

Objectives: A multipeptide vaccine designed to induce helper T-cells against melanocytic and cancer-testis antigens (6MHP) induces specific Th1-dominant CD4+ T-cell responses and CD8+ T-cell responses through epitope spreading. We hypothesized that survival of patients with stage IV melanoma vaccinated with 6MHP would exceed that of unvaccinated matched controls.
Methods: The 6MHP vaccine was administered to patients with metastatic melanoma on two clinical trials (NCT00089219 and NCT00118274). Circulating CD4+ T-cell responses were measured by proliferation or direct IFN-gamma ELIspot assay. Overall survival of vaccinated patients was compared to unvaccinated controls matched by age, metastatic site, and resection status. Factors associated with survival were identified by multivariable Cox proportional hazards analysis incorporating all variables used for matching.
Results: All 36 vaccinated patients were matched 1:1 by metastatic site, resection, and age within 5 years. Median survival was significantly longer for vaccinated patients (5.4 vs 0.6 years, p < 0.001, Figure 1), among which 67% (24/36) mounted a specific CD4+ T-cell response. In multivariable analysis, vaccination was the strongest predictor of survival (HR 0.176, p < 0.001). Among vaccinated patients, immune response (HR 0.29, p = 0.021) and resection (HR 0.06, p < 0.001) were significant predictors of survival.
Conclusions: Helper peptide vaccination is associated with favorable survival among patients with metastatic melanoma. These data support a randomized prospective trial of the 6MHP vaccine.


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