Previously, in the group of 40 subjects with ovarian cancer treated with a 12mg/kg dose of the therapy every three weeks, the ORR was 52.5%. Credit: MMD Creative/Shutterstock.

Innovent Biologics has dosed the first subject in the randomised Phase III HeriCare-Ovarian01 trial of IBI354 for treating platinum-resistant ovarian cancer (PROC) with human epidermal growth factor receptor 2 (HER2) expression.

This multicentre trial marks the first in China to focus on PROC with HER2 expression levels ranging from immunohistochemistry (IHC) 1+ to 3+.

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It aims to assess the antibody-drug conjugate’s (ADC) efficacy and safety against the investigator’s choice of chemotherapy, with overall survival (OS) and progression-free survival (PFS) as the primary endpoints.

The previous multicentre Phase I/II trial included 87 subjects with advanced solid tumours, 77% of whom had undergone a minimum of three anti-tumour regimens.

As of July 2024, findings showed an overall objective response rate (ORR) of 40.2% and a disease control rate (DCR) of 81.6%.

Notably, in the group of 40 subjects with ovarian cancer treated with a 12mg/kg dose every three weeks, the ORR was 52.5% and the DCR was 90%.

Additionally, among those with HER2 IHC 1+ expression, the ORR was 55.6% and the DCR was 88.9%.

The median follow-up period for the 12mg/kg dose group was 6.5 months, with PFS and duration of response (DoR) data still maturing at the cut-off date.

Throughout the Phase I/II study involving 368 subjects, the ADC claims to have shown an “excellent” safety profile, with no dose-limiting toxicities (DLTs) occurring up to the 18mg/kg dose group.

According to the company, the HER2-targeted ADC, IBI354 is developed by its topoisomerase inhibitor platform.

Innovent Biologics senior vice-president Dr Zhou Hui said: “I’m pleased that the Phase III clinical study of IBI354 in HER2-expressing PROC has completed the first participant dosing.

“ADC is one of the core technology areas of Innovent’s strategic layout. We combine the world’s leading antibody engineering and multiple sets of differentiated linker-payload technologies to create a highly competitive and innovative TOPO1i ADC technology platform SoloTx.”

This January, the company formed a partnership and exclusive licence agreement with Roche to further the development of IBI3009 for treating individuals with advanced small-cell lung cancer.