Eli Lilly's FRα antibody-drug conjugate (ADC), sofetabart mipitecan (LY4170156), has been granted breakthrough therapy designation (BTD) in its US homeland. The designation is for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have received prior treatment with bevacizumab and are eligible for and have progressed on mirvetuximab soravtansine. The decision is based on positive preliminary data from a Phase Ia/Ib study, which showed clinical activity across dose levels regardless of FRα expression and a manageable safety profile with low rates of key adverse events.

The therapy, which incorporates a proprietary linker and the payload exatecan with a drug-to-antibody ratio (DAR) of eight, entered a global Phase III trial (FRAmework-01) in October 2025. This study will evaluate the drug as both a monotherapy and in combination with bevacizumab across different patient populations.

According to PharmCube's NextBiopharm® database, LY4170156 is one of four advanced FRα ADC candidates in late-stage development, reflecting significant industry interest in this target for ovarian cancer. Click here to request a free trial for NextBiopharm®.