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Akeso Announces Completion of First Dosing in Phase III Clinical Trial of Ivonescimab (PD-1/VEGF) Combination Therapy for Immunotherapy-Resistant NSCLC
Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that the first patient has been dosed in its pivotal Phase III clinical study (AK112-305/HARMONi-8A) of ivonescimab (PD-1/VEGF bispecific antibody) in combination with docetaxel for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) that has progressed following PD-1/L1 inhibitors and platinum-based chemotherapy.
About this update from Akeso, Inc.
[{"type":"text","content":"HONG KONG, July 30, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that the first patient has been dosed in its pivotal Phase III clinical study (AK112-305/HARMONi-8A) of ivonescimab (PD-1/VEGF bispecific antibody) in combination with docetaxel for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) that has progressed following PD-1/L1 inhibitors and platinum-based chemotherapy.","length":471,"tagName":"p"},{"type":"text","content":"Ivonescimab is the only bispecific immunotherapy antibody currently undergoing Phase III registration trials for IO-resistant lung cancer.","length":138,"tagName":"p"},{"type":"text","content":"In recent years, immunotherapy has achieved significant progress in the treatment of NSCLC. PD-1/L1 inhibitors, whether used as monotherapy or in combination with platinum-based chemotherapy, have become the standard first-line treatment for advanced NSCLC in patients without driver mutations. However, despite these advances, 60%-70% of patients experience disease progression within the first year of treatment.","length":414,"tagName":"p"},{"type":"text","content":"Currently, there are no approved standard treatment options for IO-resistant NSCLC. Docetaxel is recommended in both China's and international treatment guidelines for immunotherapy-resistant (IO-resistant) NSCLC. However, docetaxel's monotherapy efficacy in the IO-resistant NSCLC patients remains limited. Several Phase III clinical trials investigating IO-resistant lung cancer, including immunotherapy combination therapies studies and ADC therapy studies, have failed to demonstrate positive results.","length":513,"tagName":"p"},{"type":"text","content":"Mechanistic studies suggest that PD-1 therapy can restore the immune system's anti-tumor activity, while anti-VEGF therapy alleviates VEGF-mediated immune suppression and promotes T-cell infiltration. When combined, these two therapies may produce synergistic effects. Ivonescimab simultaneously targets both PD-1 and VEGF pathways, reversing the immune-suppressive tumor microenvironment and reactivating anti-tumor immune responses. These synergistic mechanisms provide a scientific rationale for using ivonescimab to treat IO-resistant tumors. Furthermore, the positive efficacy and safety data de...