Akeso Publishes Phase III Ivonescimab Trial Results vs. Pembrolizumab in The Lancet

HONG KONG, March 7, 2025 – Akeso, Inc. has announced remarkable findings from its Phase III clinical study, HARMONi-2/AK112-303, which evaluated the efficacy of its innovative PD-1/VEGF bispecific antibody, ivonescimab. This study focused on the use of ivonescimab as a monotherapy for the first-line treatment of PD-L1 positive locally advanced or metastatic non-small cell lung cancer (NSCLC), comparing it to the current standard treatment with pembrolizumab. The promising results have been published in The Lancet, a highly respected international medical journal known for its rigorous peer-reviewed research.

The inclusion of the HARMONi-2 study in The Lancet underscores the significant clinical potential of ivonescimab, highlighting its potential to bring about a paradigm shift in cancer treatment. Previous studies on ivonescimab have also been featured in prestigious journals such as JAMA, the Journal of Thoracic Oncology, eClinical Medicine, and Drugs, reflecting the growing interest in its therapeutic capabilities.

At the 2024 World Conference on Lung Cancer (WCLC), the study results were presented by Professor Zhou Caicun, a leading oncology expert and President-Elect of the International Association for the Study of Lung Cancer (IASLC). Professor Zhou, who also leads the Department of Oncology at Shanghai East Hospital of Tongji University, emphasized the study’s significance in the field of oncology.

The HARMONi-2 study demonstrated that ivonescimab monotherapy extended progression-free survival (PFS) significantly more than pembrolizumab monotherapy. It reduced the risk of disease progression by 49% in the intent-to-treat population. These results were consistent across various subgroups, regardless of age, gender, ECOG performance status, PD-L1 expression, histological type, or presence of liver or brain metastases.

As a result of these encouraging findings, the supplementary New Drug Application (sNDA) for using ivonescimab as a first-line treatment for PD-L1 positive NSCLC is under priority review in China. Additionally, ivonescimab has already been approved for use in combination with chemotherapy for EGFR-TKI-resistant, non-squamous NSCLC, and is included in the 2024 China National Reimbursement Drug List. The extensive clinical data from multiple Phase II and Phase III trials reinforce ivonescimab's beneficial efficacy and safety profile, offering oncologists a robust scientific foundation for treatment decisions.

Akeso is strategically advancing ivonescimab’s development, aiming to revolutionize cancer immunotherapy and set a new standard of care globally. The company is conducting several international multicenter Phase III clinical trials with its partner, Summit Therapeutics. These trials include:

- The HARMONi study, which explores ivonescimab combined with chemotherapy for non-squamous NSCLC patients who have progressed after third-generation EGFR-TKI treatment. This study has completed patient enrollment and received Fast Track Designation from the U.S. FDA.

- The HARMONi-3 study, comparing ivonescimab combined with chemotherapy against pembrolizumab with chemotherapy as a first-line treatment for squamous and non-squamous NSCLC.

- The HARMONi-7 study, evaluating ivonescimab monotherapy for PD-L1 high-expressing NSCLC as a first-line treatment.

Additional clinical trials are underway or being initiated in China, such as ivonescimab with chemotherapy for squamous NSCLC, biliary tract cancer, and with AK117 (CD47) for PD-L1 positive head and neck squamous cell carcinoma, as well as for triple-negative breast cancer. These trials are expected to further demonstrate ivonescimab's potential across various cancer types and treatment settings.