This will be the second indication for which cadonilimab has received approval in China, following its use as a monotherapy treatment for recurrent or metastatic cervical cancer.

The sNDA acceptance was based on the results from the AK104-302 trial, representing the first Phase III clinical study of a PD-1/CTLA-4 bispecific antibody combined with chemotherapy for first-line treatment of gastric cancer. In November 2023, AK104-302 trial achieved its primary endpoint by demonstrating a statistically significant overall survival (OS) improvement.

Cadonilimab combined with chemotherapy significantly reduced the risk of death in all-comer patients, including those with PD-L1 CPS≥5 and PD-L1 CPS < 5. The hazard ratios (HRs) for OS among patients with different PD-L1 status were superior to the disclosed PD-1 plus chemotherapy combination treatments. The combination of cadonilimab and chemotherapy also demonstrated superior OS in patients with PD-L1 CPS < 5 as well as PD-L1 negative.

"In the real world, approximately 60% of patients exhibit low PD-L1 expression, which further underscores the need for more effective treatment options," said Professor Ji Jiafu from the Peking University Cancer Hospital. "There is a significant need to enhance overall effectiveness, particularly among patients with low PD-L1 expression. The combination of cadonilimab therapy for first-line treatment of advanced gastric cancer has shown a high tumor objective remission rate, significantly improve the overall survival of the entire population with advanced gastric cancer while reducing the risk of death. We are eagerly awaiting the earliest approval of this indication and the positive impact it will have on patients' lives."

"The combination therapy of cadonilimab demonstrates differentiated efficacy advantages compared to commonly used immunotherapy approaches in clinical practice," said Professor Lin Shen from the Peking University Cancer Hospital. "It brings significant benefits to all-comer patients regardless of PD-L1 expression, and even demonstrated strong anti-tumor effects in patients with low PD-L1 expression or negative status. This addresses the limitations of current single-target immunotherapy in clinical settings, effectively showcasing the synergistic mechanism of 'PD-1+CTLA-4' dual immune therapy. It is expected to overcome the shortcomings of current immune treatment strategies for advanced gastric cancer and represents a potentially superior immunotherapeutic approach for this condition."

"We would like to express our sincere gratitude to all the investigators, participants, and patients who actively participated in the clinical trial," said Dr. Yu Xia, Founder, Chairwoman, President, and CEO of Akeso. "The groundbreaking bispecific IO therapy from cadonilimab will soon bring significant benefits to approximately 500,000 gastric cancer patients in China, underscoring the immense clinical and market value of cadonilimab as the first PD-1/CTLA-4 bispecific antibody. Since its approval for cervical cancer treatment in 2022, cadonilimab has garnered recognition from both clinicians and patients due to its remarkable efficacy and safety. We eagerly anticipate the approval of its new indication for gastric cancer, as it will revolutionize the clinical treatment approach for advanced gastric cancer and introduce a new era of immunotherapy options for patients."