China-based Innovent Biologics, Inc. (HKG: 1801) has administered the first dose of its antibody-drug conjugate (ADC) IBI354 to a subject in the HeriCare-Ovarian01 study. This Phase III trial is a randomized, controlled, multicenter study designed to evaluate the safety and efficacy of IBI354 compared to chemotherapy in patients with HER2-expressing platinum-resistant ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
Trial Design and Objectives
The HeriCare-Ovarian01 study focuses on assessing progression-free survival (PFS) and overall survival (OS) as primary endpoints. The trial represents a significant step forward in targeting HER2-expressing cancers with innovative ADC therapy, potentially offering a more effective treatment option for patients with these aggressive conditions.
Promising Phase I/II Results
IBI354 previously demonstrated favorable safety and preliminary efficacy in Phase I/II trials. Notably, among 27 HER2 IHC 1+ subjects who received 12mg/kg every three weeks, the drug achieved an overall objective response rate (ORR) of 55.6% and a disease control rate (DCR) of 88.9%. These results highlight its potential to improve outcomes in patients with HER2-expressing cancers.-Fineline Info & Tech
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