2025 ASCO Oral Presentation: Innovent Biologics Announces Updated Data of IBI363 (First-in-class PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) from the Phase 1 PoC Clinical Study in Advanced Non-small Cell Lung Cancer

Core Viewpoint - Innovent Biologics has presented promising clinical data for IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, at the 2025 ASCO conference, demonstrating its potential efficacy in treating advanced non-small cell lung cancer (NSCLC) and other tumor types [1][2][11]. Group 1: Clinical Data and Efficacy - IBI363 has shown a manageable safety profile and encouraging efficacy in patients with immunotherapy-resistant squamous NSCLC and wild-type lung adenocarcinoma, with trends indicating long-term survival benefits [1][4][11]. - In a Phase 1 study, IBI363 monotherapy was administered to 136 NSCLC patients, with a focus on those with squamous cell carcinoma and EGFR wild-type adenocarcinoma [3][6]. - The confirmed overall response rate (ORR) for squamous NSCLC patients receiving IBI363 at different dosages was reported as 25.9% and 36.7%, with disease control rates (DCR) of 66.7% and 90.0% respectively [5][6]. Group 2: Long-term Survival Benefits - IBI363 demonstrated potential long-term survival benefits, with median overall survival (OS) of 15.3 months for the 1/1.5 mg/kg dose group and not reached for the 3 mg/kg group, alongside a 12-month OS rate of 70.9% [5][6][10]. - Among patients with PD-L1 TPS<1%, the ORR was 30.0% for the lower dose and 46.2% for the higher dose, indicating IBI363's effectiveness in low PD-L1 expression populations [7]. Group 3: Future Development Plans - Innovent plans to initiate a Phase 3 registration clinical study for IBI363 in locally advanced or metastatic squamous NSCLC patients who have failed prior treatments [11]. - The company has received Breakthrough Therapy Designation (BTD) from China CDE and Fast Track Designation (FTD) from the US FDA for IBI363 in treating squamous NSCLC [11][17]. Group 4: Company Overview - Innovent Biologics is a leading biopharmaceutical company focused on developing high-quality medicines for various diseases, including oncology, with 15 products launched and multiple assets in clinical trials [18]. - The company collaborates with over 30 global healthcare companies to advance its innovative therapies [18].