Scancell updated Phase 2 data shows continued improvement in progression free survival with iSCIB1+ in patients with first line advanced melanoma

Core Insights - Scancell Holdings plc has announced positive data from the SCOPE Phase 2 trial of iSCIB1+ in combination with ipilimumab and nivolumab, showing a significant improvement in progression-free survival (PFS) and overall survival (OS) compared to standard of care [2][4][6]. Group 1: Trial Results - The PFS for the target population was reported at 74% at 16 months, compared to 50% at 11.5 months for the standard of care [4][6]. - The overall response rate for the target population in Cohort 3 was 56%, with a disease control rate of 79% [5]. - Early OS data indicates a 14% improvement at 26 months over standard of care [4][5]. Group 2: Regulatory and Development Plans - The company is in advanced planning for registrational trials, having received positive scientific advice from regulators [1][6]. - Discussions with the U.S. Food and Drug Administration (FDA) and other regulatory agencies have been positive, supporting plans to move to Phase 3 registrational development [6][8]. - The company has decided not to continue with Cohort 4, focusing instead on the optimal method of administration for late-stage development [8]. Group 3: Target Population and Biomarkers - iSCIB1+ is selected for further development in patients with specific human leukocyte antigen (HLA) alleles, representing 80% of melanoma patients [3][12]. - The trial data supports the use of HLA as a biomarker for registrational trials, with a PFS of 20% at 14 months in the non-target population [4][12]. - The selected HLA alleles include A2, A3, A31, Bw4, B35, and B44, which are crucial for identifying potential responders in future clinical development [12].