European journal of cancer (Oxford, England : 1990) · 2025
The telomerase vaccine UV1 combined with ipilimumab and nivolumab versus ipilimumab and nivolumab in advanced melanoma (INITIUM): A randomized open-label phase 2 study.
СтатьяРандомизированное исследованиеКлиническое исследование II фазыМногоцентровое исследованиеСравнительное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Lorigan Paul, Medina Theresa Michelle, Nyakas Marta, Rutten Annemie, Feun Lynn G, Cowey Charles Lance, Payne Miranda, Hussain Israr, Kuzel Timothy, O'Day Steven, Sheri Amna, Friedlander Philip Adam, Kumar Satish, Bergersen Vanja Sue, Foss Øivind, Ellingsen Espen Basmo, Bjørheim Jens, Bechter Oliver Edgar
Аннотация
PURPOSE: Immune checkpoint inhibitor (ICI) combinations have improved outcomes in patients with advanced melanoma; however, long term survival remains poor. The addition of therapeutic cancer vaccines to ICI combinations represents a promising strategy to enhance efficacy.
METHODS: In this phase 2, randomized, open-label trial, 156 patients with unresectable or metastatic melanoma were randomized 1:1 to receive 4 cycles of ipilimumab 3mg/kg and nivolumab 1mg/kg with or without UV1, a telomerase-targeted therapeutic cancer vaccine, followed by maintenance nivolumab 480 mg every 4 weeks. The primary endpoint was progression-free survival (PFS) based on blinded independent central review. Secondary endpoints included overall survival (OS), response assessments, and safety.
RESULTS: At a minimum follow-up of 18 months, the projected median PFS was 34.3 months (95 % confidence interval [CI], 7.95 to NR) with ipilimumab-nivolumab-UV1 and 38.4 months (95 % CI, 8.15-38.37) with ipilimumab-nivolumab (hazard ratio, 0.95 [95 % CI, 0.59-1.55]). PFS at 12 months was 57 % (95 % CI, 45.0-68.1) and 57 % (95 % CI, 44.6-67.0) in the ipilimumab-nivolumab-UV1 and ipilimumab-nivolumab arms, respectively. Objective response rates were 59.7 % (ipilimumab-nivolumab-UV1) and 59.2 % (ipilimumab-nivolumab; odds ratio, 1.12; 95 % CI, 0.58-2.16). Median overall survival was not reached in either arm (hazard ratio, 1.15 [95 % CI, 0.60-2.20]). Grade > 3 treatment-emergent adverse events were reported in 64.5 % and 65.4 % of patients respectively.
CONCLUSION: For patients with treatment naïve advanced melanoma, the addition of UV1 to ipilimumab-nivolumab did not result in improved efficacy compared with ipilimumab-nivolumab alone.
METHODS: In this phase 2, randomized, open-label trial, 156 patients with unresectable or metastatic melanoma were randomized 1:1 to receive 4 cycles of ipilimumab 3mg/kg and nivolumab 1mg/kg with or without UV1, a telomerase-targeted therapeutic cancer vaccine, followed by maintenance nivolumab 480 mg every 4 weeks. The primary endpoint was progression-free survival (PFS) based on blinded independent central review. Secondary endpoints included overall survival (OS), response assessments, and safety.
RESULTS: At a minimum follow-up of 18 months, the projected median PFS was 34.3 months (95 % confidence interval [CI], 7.95 to NR) with ipilimumab-nivolumab-UV1 and 38.4 months (95 % CI, 8.15-38.37) with ipilimumab-nivolumab (hazard ratio, 0.95 [95 % CI, 0.59-1.55]). PFS at 12 months was 57 % (95 % CI, 45.0-68.1) and 57 % (95 % CI, 44.6-67.0) in the ipilimumab-nivolumab-UV1 and ipilimumab-nivolumab arms, respectively. Objective response rates were 59.7 % (ipilimumab-nivolumab-UV1) and 59.2 % (ipilimumab-nivolumab; odds ratio, 1.12; 95 % CI, 0.58-2.16). Median overall survival was not reached in either arm (hazard ratio, 1.15 [95 % CI, 0.60-2.20]). Grade > 3 treatment-emergent adverse events were reported in 64.5 % and 65.4 % of patients respectively.
CONCLUSION: For patients with treatment naïve advanced melanoma, the addition of UV1 to ipilimumab-nivolumab did not result in improved efficacy compared with ipilimumab-nivolumab alone.