Business
Continued improvement in PFS with iSCIB1+
Scancell Holdings plc announced updated Phase 2 data for its iSCIB1+ immunotherapy in advanced melanoma, showing a progression-free survival (PFS) of 74% at 16 months, significantly outperforming the standard of care's 50% PFS at 11.5 months. Early overall survival data also indicates a 14% improvement at 26 months over standard of care. The company has received positive regulatory advice and is advancing iSCIB1+ into late-stage registrational trials, targeting 80% of melanoma patients based on specific HLA alleles. Disclaimer*
About this update from Scancell Holdings Plc
[{"type":"text","content":"\n\n\n9 December 2025\n \nScancell Holdings plc\nScancell updated Phase 2 data shows continued improvement in progression free survival with iSCIB1+ in patients with first line advanced melanoma\nProgression free survival (PFS) of 74% at 16 months compares favourably to standard of care PFS of 50% at 11.5 months 1\nStrong PFS consistent across key subgroups\nReaffirms selection of iSCIB1+ and target HLA population for late-stage development\nEarly overall survival (OS) data, most advanced for SCIB1, showing a 14% improvement at 26 months over SoC1\nIn advanced planning for registrational trials with positive scientific advice from regulators\nTo hold late-breaking oral presentation on SCOPE trial at ESMO IO conference\nInvestor webinar on Thursday 11th December 2025 at 2.00pm GMT\nScancell Holdings plc (AIM: SCLP), the developer of active immunotherapies to treat cancer, announces updated positive data from the SCOPE Phase 2 trial of iSCIB1+ in combination with ipilimumab and nivolumab, current standard of care (SoC). A late-breaking abstract on the data has been released, and an additional poster presentation will be made during an oral session at the ESMO Immuno-Oncology Congress 2025 (ESMO IO) conference on 11th December 2025.\nResults from SCOPE to date have enabled Scancell to select Immunobody iSCIB1+, administered needle-free intramuscularly, for further development in patients with selected human leukocyte antigen (HLA) alleles (\"the target population\"), representing 80% of melanoma patients. This profile is reflected within Cohort 3 of the SCOPE trial.\nUpdated data in this cohort show progression free survival (PFS) was 74% at 16 months in the target population. This compares favourably to PFS reported with ipilimumab plus nivolumab alone of 50% at 11.5 months[1]. The favourable PFS remains consistent across key subgroups analysed including PD-L1 low, BRAF Wildtype and prior checkpoint inhibitor exposure, who might be expected to have worse outcomes. Cohort 3 comprised a total of 50 patients of which 39 were in the target HLA population, 10 outside the target HLA population and one was non-evaluable due to active brain metastases. Data in this cohort from the non-target population support the use of HLA as a biomarker for a registrational trial, with PFS of 20% at 14 months and overall response ra...