AbbVie’s mirvetuximab soravtansine meets Phase 2 efficacy endpoint

AbbVie announced positive topline results from the Phase 2 PICCOLO trial evaluating investigational mirvetuximab soravtansine monotherapy in heavily pre-treated patients with folate receptor-alpha positive, platinum-sensitive ovarian cancer. The study met its primary endpoint with an objective response rate – ORR – of 51.9%. In addition, the median duration of response, a key secondary endpoint, was 8.25 months. The safety profile of mirvetuximab soravtansine was consistent with findings from previous studies, and no new safety concerns were identified. Full data from the PICCOLO study will be presented at a future medical meeting. Mirvetuximab soravtansine is also being studied in PSOC in the Phase 3 GLORIOSA trial, in combination with bevacizumab versus bevacizumab alone in maintenance after second-line platinum-doublet therapy.