Ultimovacs has announced an amendment to the Phase II INITIUM trial, assessing lead cancer vaccine UV1 in combination with PD-1 checkpoint inhibitor nivolumab and CTLA-4 checkpoint inhibitor ipilimumab for the first-line treatment of malignant melanoma. The amendment allows the company to commence data analysis from mid-January 2024 and share top-line results in March or April 2024. This practical and proactive approach assists in unlocking the value of the programme (out-licensing) or progressing to pivotal studies if the data are positive. Top-line results were initially expected in H123, but the timeline was pushed back twice to H223 and H124 as patients were taking longer than expected to experience disease progression. We view this as a possible positive indicator for trial success (although not definitive as it is possible that the control arm may be experiencing slower than expected progression).Den vollständigen Artikel lesen ...