Innovent Delivers Oral Presentation on Phase 1 Clinical Data of IBI363 (First-in-class PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) in Advanced Non-small Cell Lung Cancer at the 2024 WCLC

Core Insights - Innovent Biologics announced Phase 1 clinical data for IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, at the 2024 World Conference on Lung Cancer, focusing on its application in advanced non-small cell lung cancer (NSCLC) [1][4] Group 1: Clinical Data and Efficacy - As of August 2, 2024, 134 patients were enrolled in the study, with 95.5% having received prior PD-(L)1 immunotherapy. The overall objective response rate (ORR) was 20.8% and disease control rate (DCR) was 74.4% [1][3] - In the subgroup receiving 3 mg/kg Q3W, the ORR was 34.5% and DCR was 79.3%, with a notable 50% ORR and 88.9% DCR among patients with at least 12 weeks of follow-up [2][3] - The median progression-free survival (PFS) for patients treated with 1/1.5 mg/kg was 5.5 months, while the median PFS for the 3 mg/kg group has not yet been reached [3] Group 2: Safety Profile - IBI363 demonstrated a manageable safety profile, with 20.1% of patients experiencing treatment-related adverse events (TRAEs) of grade 3 or higher, and 6.0% discontinuing treatment due to TRAEs [3] - In the 3 mg/kg Q3W subgroup, 17.5% experienced TRAEs ≥ grade 3, and 5.3% discontinued treatment due to TRAEs, indicating consistency in safety across different dosage groups [3] Group 3: Future Directions - The company plans to continue investigating the long-term efficacy and safety of IBI363, as well as its potential in combination with other therapies and in different solid tumors [4] - Additional studies are underway to evaluate IBI363's effectiveness in treating cold tumors with low or absent PD-L1 expression, which could represent a significant advancement in NSCLC treatment [5][6] Group 4: Company Overview - Innovent Biologics, founded in 2011, focuses on developing high-quality biopharmaceuticals for various diseases, including cancer and autoimmune disorders. The company has launched 11 products and has multiple assets in clinical trials [7][8]