Akeso, Inc. announced the company has successfully enrolled the first patient in its multicenter, randomized, double-blind Phase III clinical trial of ivonescimab in combination with chemotherapy for first-line treatment for unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) (HARMONi-BC1/AK112-308). Ivonescimab is a first-in-class PD-1/VEGF bispecific antibody independently developed by the company.

HARMONi-BC1/AK112-308 study is led by Professor Xu Binghe, a renowned breast cancer expert and academician of the Chinese Academy of Engineering, from the Cancer Hospital of the Chinese Academy of Medical Sciences. Preliminary efficacy data presented at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting demonstrated that ivonescimab combined with chemotherapy showed significant therapeutic efficacy and also exhibited a favorable safety profile, underscoring its clinical potential for the treatment of locally advanced or metastatic TNBC.

Akeso has strategically positioned ivonescimab within a comprehensive development plan, aiming to reshape the landscape of cancer immunotherapy and establish a new global standard of care. Ivonescimab, in combination with chemotherapy, has been approved in China for the treatment of EGFR-TKI-resistant, non-squamous NSCLC. The New Drug Application (sNDA) for ivonescimab monotherapy as a first-line treatment for PD-L1-positive NSCLC (in comparison to pembrolizumab) is currently under review and has been granted priority status in China.

Three international multicenter Phase III clinical trials, led by our partner Summit Therapeutics, are progressing efficiently or are being initiated:

• The HARMONi study, an international multicenter Phase III clinical trial evaluating ivonescimab in combination with chemotherapy for non-squamous NSCLC with progression after third-generation EGFR-TKI treatment, has had patient enrollment completed and has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA),
• The HARMONi-3 study, an international multicenter Phase III clinical trial comparing ivonescimab combined with chemotherapy as first-line treatment for both squamous and non-squamous NSCLC (versus pembrolizumab combined with chemotherapy),
• The HARMONi-7 study, an international multicenter Phase III clinical trial evaluating ivonescimab monotherapy as first-line treatment for PD-L1 high-expressing NSCLC (versus pembrolizumab).

Several Phase III clinical trials are progressing efficiently or are being initiated in China, including:

• Ivonescimab combined with chemotherapy as first-line treatment for squamous NSCLC (vs. tislelizumab combined with chemotherapy, HARMONi-6/AK112-306),
• Ivonescimab combined with chemotherapy as first-line treatment for biliary tract cancer (vs. durvalumab combined with chemotherapy, HARMONi-GI1/AK112-309),
• Ivonescimab combined with AK117 (CD47) as first-line treatment for PD-L1 positive head and neck squamous cell carcinoma (vs. pembrolizumab, SOLO-10/AK117-302),
• First-line treatment for pancreatic cancer (HARMONi-GI2/AK112-310),
• First-line treatment for triple-negative breast cancer (HARMONi-BC1/AK112-308).