Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is excited to announce that the prestigious medical journal Nature Medicine published the results of the company's independently developed PD-1/CTLA-4 bispecific antibody cadonilimab in combination with oxaliplatin and capecitabine for the first-line treatment of unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma in a Phase III clinical study (COMPASSION-15/AK104-302). The results of the COMPASSION-15 study were previously orally presented at the 2024 American Association for Cancer Research (AACR) Annual Meeting.

This recognition represents an additional validation of cadonilimab's clinical value in addressing critical unmet need. Previously, clinical research findings on cadonilimab in the treatment of various malignancies have been published in internationally renowned journals such as The Lancet, The Lancet Oncology, Nature Medicine, Drugs, and Clinical Cancer Research.

The Phase III clinical data in the Nature Medicine publication indicates that, regardless of PD-L1 expression, cadonilimab combined with chemotherapy regimen significantly improves overall survival benefits for the entire population of advanced gastric cancer patients and reduces the risk of disease-related death (OS HR 0.62). Even for the PD-L1 low-expressing and negative group, the cadonilimab regimen demonstrated a meaningful survival benefit for patients (OS HR 0.70), effectively addressing the current limitations of PD-1 monoclonal antibody first-line treatment for PD-L1 low-expression and negative gastric cancer.

In September 2024, the cadonilimab regimen for the first-line treatment of advanced gastric cancer was approved and is now widely used in clinical practice, offering a comprehensive and efficacious immunotherapy option for patients. A Phase III clinical trial of cadonilimab combined with a VEGFR-2 monoclonal antibody for PD-1/L1 inhibitor-pretreated advanced gastric adenocarcinoma and gastroesophageal junction adenocarcinoma patients is currently advancing on scheduling. Akeso's comprehensive clinical strategy for both first-line and subsequent-line treatments in various cancer types will further expand cadonilimab's indications, providing a novel and effective solution for these patients. Cadonilimab's ability to target both PD-1 and CTLA-4, two key immune checkpoints, demonstrates its synergistic anti-tumor mechanisms, further demonstrating Akeso's leadership in the global bispecific antibody field for cancer immunotherapy.

Currently, cadonilimab is being investigated in over 23 clinical studies across 16 indications, targeting tumor types such as gastric cancer, lung cancer, liver cancer, cervical cancer, and pancreatic cancer. In addition to the already approved indications for recurrent/metastatic cervical cancer and first-line gastric cancer, as well as the first-line cervical cancer indication currently under review, cadonilimab is also undergoing five Phase III clinical trials for liver cancer, non-small cell lung cancer, and gastric cancer. Research across multiple indications, including cervical cancer, gastric cancer, and non-small cell lung cancer, has demonstrated that cadonilimab exhibits breakthrough efficacy across "broad population", demonstrating clinically meaningful positive outcomes for PD-L1 high-expressing, low-expressing, and even PD-L1-negative patient populations. Clinical benefit across multiple cancer types and tumor PD-L1 expression status shows that cadonilimab not only advances current cancer immunotherapies, but also significantly broadens their patient coverage. Cadonilimab holds the potential to become a cornerstone drug in the next generation of cancer immunotherapy and is expected to be widely used in combination with antibody-drug conjugates (ADCs) and other high-potential targets.