AbbVie has reported positive topline data from the Phase II PICCOLO clinical trial of mirvetuximab soravtansine (ELAHERE) monotherapy in heavily pre-treated high folate receptor-alpha (FRα)-positive platinum-sensitive ovarian cancer (PSOC) patients.
The single-arm study aimed to assess the efficacy and safety of mirvetuximab soravtansine in FRα high PSOC patients who were treated with a minimum of two lines of platinum-containing therapy priorly or have a documented platinum allergy.
Go deeper with GlobalData
Objective response rate (ORR) was the primary endpoint while the key secondary endpoint comprised the duration of response (DOR).
The trial met the endpoints with an ORR of 51.9% and a median DOR of 8.25 months.
Mirvetuximab soravtansine’s safety profile in the trial was in line with data from prior studies without any new safety concerns detected.
Apart from the PICCOLO trial, the asset is under investigation in the Phase III GLORIOSA trial, where it is being tested along with bevacizumab versus bevacizumab alone as a maintenance therapy post-second-line platinum-doublet treatment.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataCurrently, mirvetuximab soravtansine is approved in the US under the brand name ELAHERE for treating FRα-positive platinum-resistant ovarian cancer, including cases originating in the fallopian tube or peritoneum, after one to three prior systemic treatment regimens.
The European Medicines Agency (EMA) accepted the marketing authorisation application (MAA) for ELAHERE with regulatory reviews underway in several other countries.
Prior to this development, AbbVie treated the first subject in the Phase III CERVINO trial of its investigational product ABBV-383 for relapsed/refractory multiple myeloma.
The multi-centre, open-label, randomised, global CERVINO trial is designed to assess ABBV-383 against standard available therapies.
