Two Ivonescimab (PD-1/VEGF) Results including Phase 3 Monotherapy versus Pembrolizumab Monotherapy in First-Line Treatment for PD-L1 Positive NSCLC to Be Presented at WCLC 2024

Core Insights - Ivonescimab is the first drug to demonstrate a clinically meaningful benefit over pembrolizumab in a randomized Phase III clinical trial for non-small cell lung cancer (NSCLC) [1][3][11] Group 1: Clinical Study and Presentations - The HARMONi-2/AK112-303 study results will be presented at the IASLC 2024 World Conference on Lung Cancer, showcasing ivonescimab's efficacy against pembrolizumab in patients with PD-L1 positive NSCLC [1][2] - The primary analysis of the HARMONi-2 study indicates a statistically significant improvement in progression-free survival (PFS) for ivonescimab compared to pembrolizumab, with a favorable hazard ratio [3][4] Group 2: Regulatory Approvals and Collaborations - Ivonescimab received marketing approval in May 2024 for treating EGFR mutated locally advanced or metastatic non-squamous NSCLC, marking it as the world's first approved PD-1/VEGF bispecific antibody [3][11] - The supplemental New Drug Application (sNDA) for ivonescimab as a monotherapy for first-line treatment of PD-L1 positive NSCLC has been accepted by the China National Medical Products Administration (NMPA) [6][7] Group 3: Company Overview and Pipeline - Akeso is a leading biopharmaceutical company focused on innovative biological medicines, with a robust pipeline of over 50 assets, including 19 drug candidates in clinical stages [9][10] - The company has successfully commercialized three innovative biological drugs and is actively engaged in multiple clinical trials for various cancer indications [10][11]