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Nature Medicine Published Phase 1 Results of Innovent Biologics' Anti-CLDN18.2 ADC (IBI343) in Patients with Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
Prnewswire· 2025-07-17 00:00
Core Insights - Innovent Biologics announced the publication of Phase 1 clinical study results for IBI343, an anti-CLDN18.2 ADC, in Nature Medicine, highlighting its potential in treating advanced gastric/gastroesophageal junction adenocarcinoma [1][4][8] - Gastric cancer is a significant global health issue, ranking as the fifth most common malignant tumor with approximately 970,000 new cases and 660,000 deaths annually, with China accounting for a substantial portion of these figures [2][10] - The study demonstrated promising efficacy and safety profiles for IBI343, with an overall response rate of 32.3% at 6 mg/kg and 47.1% at 8 mg/kg, indicating its potential as a new treatment option [7][8][12] Company Overview - Innovent Biologics is a leading biopharmaceutical company focused on developing high-quality medicines for various diseases, including oncology, cardiovascular, and autoimmune disorders [16][17] - The company has launched 16 products and has multiple assets in clinical trials, including IBI343, which is currently undergoing a multi-regional Phase 3 trial for advanced gastric cancer [17][14] Clinical Study Details - The Phase 1 clinical trial enrolled 116 patients with advanced G/GEJ adenocarcinoma, assessing the safety, tolerability, and preliminary efficacy of IBI343 [4][6] - The study found that 66.4% of patients experienced grade ≥3 treatment-emergent adverse events, with the most common being decreased neutrophil count and white blood cell count [6][8] - The recommended Phase 2 dose of IBI343 is established at 6 mg/kg, supporting its advancement to Phase 3 trials [8][14] Market Need - There is a significant unmet medical need for effective treatments for advanced gastric cancer, with current standard therapies offering limited efficacy and poor prognosis for patients [10][12] - The high incidence of gastric cancer in China and Japan underscores the urgency for innovative treatment options like IBI343 [10][11] Future Directions - The Phase 3 trial (G-HOPE-001) aims to further evaluate IBI343 against standard treatments, with the goal of reshaping clinical practice in gastric cancer management [9][14] - Innovent is also exploring the therapeutic potential of IBI343 in other cancers, such as pancreatic cancer, indicating a broader application of this innovative therapy [9][15]