IBI354

Search documents
2025 ASCO Presentation: Innovent Biologics Announces Updated Data of IBI354 (Novel anti-HER2 ADC) From the Phase 1/2 Clinical Study in Advanced Ovarian Cancer, Breast Cancer and Other Solid Tumors
Prnewswire· 2025-06-03 01:00
Core Viewpoint - Innovent Biologics has presented promising clinical data for IBI354, a HER2 monoclonal antibody-camptothecin derivative conjugate, at the 2025 ASCO Annual Meeting, highlighting its potential in treating advanced solid tumors, particularly in ovarian and breast cancer [1][2]. Group 1: Clinical Data and Efficacy - IBI354 has shown promising anti-tumor efficacy and favorable safety profiles across multiple solid tumors, indicating its potential as a new generation of ADC therapies characterized by high potency and low toxicity [2][5]. - The Phase 1/2 clinical study enrolled 368 participants with advanced solid tumors, with a median follow-up duration of 11.5 months and a median treatment duration of 27.0 weeks [3]. - In the ovarian cancer cohort, IBI354 achieved an objective response rate (ORR) of 55.0% and a disease control rate (DCR) of 90.0% at a dose of 12mg/kg Q3W, with a median progression-free survival (PFS) of 7.1 months [6][7]. Group 2: Safety Profile - IBI354 demonstrated an excellent safety profile, with a low incidence of treatment-related adverse events (TRAEs) and no dose-limiting toxicities (DLTs) observed at escalated doses [4][7]. - The most common TRAEs included anemia, nausea, and decreased white blood cell count, with only 1.9% of patients experiencing interstitial lung disease [7]. Group 3: Future Development and Strategic Positioning - The Phase 3 study of IBI354 in platinum-resistant ovarian cancer has been initiated, indicating the company's commitment to further validating the long-term benefits of this treatment [8]. - Innovent is advancing its strategic layout in the ADC field, with plans for additional clinical studies and investments in next-generation ADC molecules to address unmet clinical needs [8][10].
2025 ASCO年会即将揭幕 国产创新药多项研究成果亮相国际舞台
Xin Lang Zheng Quan· 2025-05-27 08:41
Core Insights - The 2025 ASCO Annual Meeting will take place from May 30 to June 3 in Chicago, showcasing significant advancements in innovative drug development from Chinese pharmaceutical companies [1][5] - Multiple drugs with "first-in-class" or "best-in-class" potential have been selected for oral presentations, highlighting the R&D capabilities of Chinese biotech firms [1] Group 1: Company Highlights - Innovent Biologics has seven studies selected for oral presentations, including IBI363 (PD1xIL2 bispecific antibody) with clinical data on non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and malignant pleural mesothelioma (MLN) [1] - China Biologic Products has twelve studies selected, with four classified as "latest breakthrough abstracts" (LBA), notably the combination of bemarituzumab and anlotinib for first-line treatment of NSCLC [1] - Kelun-Biotech will present six research outcomes, focusing on SKB264 (TROP2 ADC), A167 (PD-L1 monoclonal antibody), and A400 (RET inhibitor) [2] Group 2: Drug Development Focus - Antibody-drug conjugates (ADCs) are a major focus for domestic pharmaceutical companies at this year's meeting, with several companies showcasing their ADC products [2] - Baiyuntianheng's bispecific ADC BL-B01D1 (EGFRxHER3) will present Phase I clinical data for small cell lung cancer (SCLC) and NSCLC [3] - Zai Lab's ZG006 (DLL3xCD3 tri-antibody) will release Phase II dose expansion data for SCLC patients, along with updates on other dual-target antibodies [3] Group 3: Key Clinical Data - The combination therapy of vidutolimab and trastuzumab for HER2-positive gastric cancer will be presented in a rapid oral report [4] - The c-MET ADC RC108 will also update its progress during the meeting [4] - The ASCO 2025 meeting is positioned as a crucial platform for Chinese innovative drug companies to showcase their breakthroughs in key indications, further promoting the internationalization of domestic innovations [5]