Akeso Begins Phase III Trial of Ivonescimab with Chemotherapy for Triple-Negative Breast Cancer

HONG KONG, Feb. 20, 2025 – Akeso, Inc. has announced a significant milestone in cancer treatment through its advancement of ivonescimab, an innovative PD-1/VEGF bispecific antibody. The company successfully initiated its first patient enrollment in a Phase III clinical trial, focusing on the drug's use in combination with chemotherapy for treating unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). This trial, known as HARMONi-BC1/AK112-308, marks a pivotal step in exploring new treatment avenues for a particularly aggressive form of breast cancer.

The study is being conducted under the leadership of Professor Xu Binghe, a respected breast cancer specialist affiliated with the Cancer Hospital of the Chinese Academy of Medical Sciences. Early data from the 2024 European Society for Medical Oncology (ESMO) Annual Meeting highlighted the promising efficacy and safety of ivonescimab when paired with chemotherapy. These findings underscore its potential as an effective treatment for patients battling advanced TNBC.

Strategically, Akeso is positioning ivonescimab to revolutionize cancer immunotherapy, aiming to establish a new global benchmark for treatment standards. In China, ivonescimab, in combination with chemotherapy, has already been approved for treating EGFR-TKI-resistant non-squamous non-small cell lung cancer (NSCLC). Moreover, the drug is undergoing priority review as a monotherapy for first-line treatment of PD-L1-positive NSCLC, in comparison to pembrolizumab, highlighting the drug’s versatile application in cancer treatment.

Akeso is also making strides internationally through collaborations with Summit Therapeutics in conducting several Phase III clinical trials. These include an international multicenter trial known as HARMONi, examining the efficacy of ivonescimab with chemotherapy in non-squamous NSCLC post third-generation EGFR-TKI treatment. This study has achieved patient enrollment and has been granted Fast Track Designation by the U.S. FDA. The HARMONi-3 trial is assessing ivonescimab with chemotherapy for first-line treatment of NSCLC, comparing its efficacy to pembrolizumab. Meanwhile, the HARMONi-7 trial is evaluating ivonescimab as a monotherapy for PD-L1 high-expressing NSCLC.

In China, several Phase III trials are either underway or in preparation. These include evaluating ivonescimab combined with chemotherapy for squamous NSCLC, comparing its efficacy against tislelizumab. Trials are also exploring its use for biliary tract cancer and PD-L1 positive head and neck squamous cell carcinoma, the latter incorporating AK117 (CD47). Additionally, ivonescimab is being investigated for first-line treatment of pancreatic cancer and TNBC.

Akeso, founded in 2012, has established itself as a leading force in biopharmaceutical innovation. The company employs a distinctive R&D system, integrating a comprehensive drug development platform and bi-specific antibody technology. This approach supports a robust pipeline of over 50 innovative assets targeting cancer, autoimmune diseases, inflammation, and metabolic disorders. Notably, 22 of these candidates have progressed to clinical trials, with a focus on bispecific and multispecific antibodies. Currently, five new drugs have been commercialized, while others await regulatory approval.

Akeso remains dedicated to advancing global healthcare through innovative therapies, aiming to provide accessible and effective treatment options for patients worldwide. Through its commitment to excellence in research and development, Akeso is poised to enhance its standing as a leading global biopharmaceutical enterprise, delivering both commercial success and social impact.