Akeso Biopharma Inc. (HKG: 9926) announced that its self-developed PD-1/CTLA-4 bispecific antibody, Cadonilimab injection (AK104), has been approved by the National Medical Products Administration (NMPA) in China for a new indication. This is the second indication for the product in China and is for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma in combination with fluorouracil-based and platinum-containing chemotherapy.
Gastric cancer is one of the most common malignant tumors worldwide, with over 1 million new cases annually according to the latest epidemiological data from 2020, making it the fifth most common malignant tumor globally. China accounts for about half of the new cases and deaths worldwide. For patients with no surgical cure or metastatic gastric cancer (including gastroesophageal junction cancer), immunotherapy represented by immune checkpoint inhibitors such as PD-1 monoclonal antibodies is one of the frontier therapies. However, compared with traditional chemotherapy, the survival benefits brought by PD-1 monoclonal antibody combined with chemotherapy as a first-line therapy are still relatively limited, and more efficient clinical treatment methods are urgently needed.
The approval of the new indication for the Cadonilimab combination therapy for gastric cancer is based on the COMPASSION-15/AK104-302 study. In the COMPASSION-15 study, the proportion of patients with PD-L1 CPS < 5 and PD-L1 CPS < 1 in the intent-to-treat population (ITT) reached 49.8% and 23%, respectively, which is significantly higher than the data disclosed in previous phase III studies of other immunotherapies for first-line gastric cancer.
In November 2023, the study met the primary endpoint of overall survival (OS) in the interim analysis. The results showed that the Cadonilimab combination therapy can significantly reduce the risk of death in the entire population of patients with advanced gastric cancer (including those with PD-L1 CPS ≥ 5 and PD-L1 CPS < 5), extending the overall survival benefit for patients and showing outstanding benefits for tumor treatment objective response and long-term survival. Previous phase III clinical study data of PD-1 inhibitors combined with chemotherapy showed limited or no additional benefits for patients with low PD-L1 expression or negative expression.- Flcube.com
