Innovent dosed first participant in Phase 3 clinical study of IBI354 (novel HER2 ADC) for platinum-resistant ovarian cancer

CAR-T Digest - August 2020

24 Mar 2025: Innovent Dosed First Participant in Phase 3 Clinical Study of IBI354 (Novel HER2 ADC) for Platinum-resistant Ovarian Cancer

Innovent Biologics has successfully dosed the first participant in a Phase 3 trial (HeriCare-Ovarian01) for platinum-resistant ovarian cancer (PROC) with HER2 expression using IBI354 (HER2 ADC)
This is the first Phase 3 trial in China to investigate PROC with HER2 expression, evaluating IBI354 against standard chemotherapy, with primary endpoints of progression-free survival (PFS) and overall survival (OS)
In a prior Phase 1/2 study, IBI354 showed promising efficacy, with an overall objective response rate (ORR) of 40.2% and a disease control rate (DCR) of 81.6%, with even higher response rates in certain subgroups
The treatment demonstrated a strong safety profile, with no dose-limiting toxicity (DLT) up to an 18 mg/kg dose and a low incidence of severe treatment-related adverse events (TRAEs)