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

Core Viewpoint - Innovent Biologics has initiated the first participant dosing in a Phase 3 clinical trial (HeriCare-Ovarian01) for IBI354, targeting platinum-resistant ovarian cancer with HER2 expression, addressing an urgent medical need in this patient population [1][2][8]. Company Overview - Innovent Biologics is a biopharmaceutical company focused on developing high-quality medicines for various diseases, including oncology, cardiovascular, and autoimmune conditions [1][13]. - The company has launched 15 products and has multiple assets in various stages of clinical trials, indicating a robust pipeline and commitment to innovation [13]. Clinical Trial Details - The HeriCare-Ovarian01 trial is the first Phase 3 study in China for platinum-resistant ovarian cancer with HER2 expression, evaluating the safety and efficacy of IBI354 against standard chemotherapy [2][5]. - The primary endpoints of the trial include progression-free survival (PFS) and overall survival (OS) [2]. Previous Study Results - In a prior Phase 1/2 study, IBI354 demonstrated a 40.2% overall objective response rate (ORR) and an 81.6% disease control rate (DCR) among participants with platinum-resistant ovarian cancer [7]. - Notably, the ORR reached 52.5% and DCR 90.0% in patients treated with a 12 mg/kg dose [7]. Safety Profile - IBI354 has shown an excellent safety profile, with a low incidence of treatment-related adverse events (TRAEs) and no dose-limiting toxicities reported up to an 18 mg/kg dose [7][4]. - The most common TRAEs included nausea and decreased white blood cell count, with a very low incidence of interstitial lung disease [7]. HER2 Targeting - Approximately 38% of ovarian cancer patients express HER2, and there are currently no approved anti-HER2 treatments for this condition in China, highlighting the potential market opportunity for IBI354 [9][10]. - IBI354 is an innovative HER2-targeted antibody-drug conjugate developed using a proprietary platform, showcasing promising safety and efficacy signals [10][11]. Future Development - Innovent plans to expand the development of IBI354 to multiple solid tumor indications beyond ovarian cancer, indicating a strategic focus on broadening its therapeutic applications [12].