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Akeso Announces The Publication of Its Phase III Clinical Trial Results for Ivonescimab in Head-to-Head Comparison with Pembrolizumab in The Lancet
Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is excited to announce that the groundbreaking results of the Phase III clinical study (HARMONi-2/AK112-303) of its first-in-class PD-1/VEGF bispecific antibody, ivonescimab, as a monotherapy compared to pembrolizumab monotherapy in the first-line treatment of PD-L1 positive (PD-L1 TPS ≥1%) locally advanced or metastatic non-small cell lung cancer (NSCLC) have been published in The Lancet.
About this update from Akeso, Inc.
[{"type":"text","content":"HONG KONG, March 7, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is excited to announce that the groundbreaking results of the Phase III clinical study (HARMONi-2/AK112-303) of its first-in-class PD-1/VEGF bispecific antibody, ivonescimab, as a monotherapy compared to pembrolizumab monotherapy in the first-line treatment of PD-L1 positive (PD-L1 TPS ≥1%) locally advanced or metastatic non-small cell lung cancer (NSCLC) have been published in The Lancet.","length":502,"tagName":"p"},{"type":"text","content":"The Lancet is a prestigious international medical journal, and the publication of the HARMONi-2 study results in The Lancet is a strong recognition by the academic community to the breakthrough clinical potential of ivonescimab. Previously, clinical research on using ivonescimab for the treatment of various malignant tumors has been published in renowned international medical journals such as JAMA, Journal of Thoracic Oncology, eClinical Medicine (a sub-journal of The Lancet), and Drugs.","length":498,"tagName":"p"},{"type":"text","content":"At the 2024 World Conference on Lung Cancer (WCLC), the results of the HARMONi-2 study were presented as an oral report by the principal investigator of the study, Professor Zhou Caicun, a renowned oncology expert who is the President-Elect of IASLC, and the director of the Department of Oncology at the Shanghai East Hospital, Tongji University.","length":347,"tagName":"p"},{"type":"text","content":"The HARMONi-2 study demonstrated that in the intent-to-treat population, ivonescimab monotherapy significantly extended progression-free survival (PFS) compared to pembrolizumab monotherapy, reducing the risk of disease progression by 49% (PFS HR 0.51, P<0.0001). Subgroup analyses revealed that regardless of patients' age, gender, ECOG performance status, PD-L1 expression, histological type, or the presence of liver or brain metastases, the ivonescimab group showed significant improvement in efficacy compared to the pembrolizumab group. The ivonescimab HARMONi-2 study is the world's first randomized, double-blind, controlled Phase III clinical trial to achieve significantly positive results compared to pembrolizumab.","length":737,"tagName":"p"},{"type":"text","content":"Based on these promising results, the sNDA for ivonescimab mon...