AbbVie declares positive Phase II ovarian cancer trial data

AbbVie announced positive results from the Phase II PICCOLO trial of mirvetuximab soravtansine (ELAHERE) monotherapy in heavily pre-treated high folate receptor-alpha (FRα)-positive platinum-sensitive ovarian cancer (PSOC) patients.

The trial aimed to assess mirvetuximab soravtansine's efficacy and safety in FRα high PSOC patients who had received at least two lines of platinum-containing therapy or had a documented platinum allergy.

Primary endpoint: objective response rate (ORR). Key secondary endpoint: duration of response (DOR). The trial met both endpoints, with an ORR of 51.9% and a median DOR of 8.25 months.

Safety profile consistent with prior studies, no new safety concerns detected.

Mirvetuximab soravtansine is also under investigation in the Phase III GLORIOSA trial, assessing its use with bevacizumab versus bevacizumab alone as maintenance therapy post-second-line platinum-doublet treatment.

ELAHERE is approved in the US for FRα-positive platinum-resistant ovarian cancer. 

AbbVie initiated the Phase III CERVINO trial for its investigational product ABBV-383 in relapsed/refractory multiple myeloma.