Core Insights - The SCOPE trial of SCIB1/iSCIB1+ shows promising results in treating advanced unresectable melanoma, indicating a potential new benchmark for efficacy, durability, immune responses, and safety [2][3][5] Efficacy and Safety - The overall response rate (ORR) for iSCIB1+ in target HLA type patients was 69%, significantly higher than the 48-50% ORR for standard care [1][4] - The 12-month progression-free survival (PFS) for Cohort 1 was 64.6%, and for Cohort 3, it was 80.8%, compared to 43.9% for the standard treatment [4][5] - The safety profile of SCIB1/iSCIB1+ combinations was consistent with that of ipilimumab and nivolumab alone, indicating no additional safety concerns [4][6] Future Development Plans - iSCIB1+ has been selected for further development, with plans for a registrational Phase 2b/3 global study being accelerated [1][7] - The study aims to enroll over 140 patients and evaluate the efficacy, safety, and durability of SCIB1/iSCIB1+ in combination with standard checkpoint inhibitors [7][9] Biomarker Potential - The data suggests the possibility of a patient selection biomarker based on HLA class I alleles, which could enhance participant selection for future studies [5][6] Market Context - The combination of ipilimumab and nivolumab currently holds a market share of 65-70% among metastatic melanoma patients in the US, highlighting the competitive landscape [7]