NMPA Approves Akeso's Cadonilimab for First-Line Gastric/GEJ Cancer Treatment

HONG KONG, Sept. 30, 2024 – Akeso (9926.HK) has announced that its innovative PD-1/CTLA-4 bispecific antibody, cadonilimab, has been approved by the National Medical Products Administration (NMPA) for a new medical application. This new indication allows cadonilimab to be used in combination with fluoropyrimidine and platinum-based chemotherapy as a first-line treatment for patients suffering from locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. This marks the second approval for cadonilimab in China, following its initial market approval in June 2022.

The new approval is based on findings from the COMPASSION-15/AK104-302 study. In this study, it was found that patients with PD-L1 CPS <5 and PD-L1 CPS <1 in the Intention-to-Treat (ITT) population reached proportions of 49.8% and 23%, respectively. These figures are significantly higher compared to those reported in previous phase III studies of other immunotherapies for first-line treatment of gastric cancer.

An interim analysis carried out in November 2023 revealed that the study met its primary endpoint of overall survival (OS). The results highlighted that cadonilimab, combined with chemotherapy, considerably reduced the risk of death across all levels of PD-L1 expression, thereby extending overall survival benefits. The study demonstrated notable improvements in objective response and long-term survival, particularly for patients with low or negative PD-L1 expression, who previously saw limited benefits from other PD-1 inhibitors combined with chemotherapy.

The results from the COMPASSION-15 study were presented at the 2024 American Association for Cancer Research (AACR). Within the ITT population, the median overall survival (mOS) for the cadonilimab regimen reached 15.0 months, compared to 10.8 months for the control group. This extended survival by 4.2 months and reduced the risk of death by 38% (HR=0.62). For the PD-L1 CPS <5 group, the cadonilimab regimen showed a mOS of 14.8 months, with a 30% reduction in the risk of death compared to the control group (11.1 months, HR=0.70). For those with PD-L1 CPS ≥5, the mOS had not been reached yet, but there was a 44% reduction in the risk of death compared to the control group (10.6 months, HR=0.56).

Professor Ji Jiafu from Peking University Cancer Hospital, who is the principal investigator of COMPASSION-15, emphasized the poor prognosis of advanced gastric cancer and the need for more effective treatments. He noted that the cadonilimab combination therapy not only improved the objective response rate and overall survival but also showed significant benefits for patients with both high and low PD-L1 CPS expression.

The approval of cadonilimab as a first-line treatment addresses the efficacy gap left by PD-1/L1 monoclonal antibodies in patients with low or negative PD-L1 expression, providing a more comprehensive immunotherapy option for advanced gastric cancer.

Professor Shen Lin, another principal investigator from Peking University Cancer Hospital, expressed optimism about the approval, highlighting its advantages over current immunotherapy options. Shen Lin pointed out that cadonilimab addresses the limitations of single-target immunotherapy through its dual-action mechanism, filling an important clinical gap.

Dr. Xia Yu, Founder, Chairwoman, President, and CEO of Akeso Biopharma, thanked all involved in the clinical study for their contributions. She emphasized that cadonilimab represents a novel bispecific immune therapy that offers significant benefits for the entire gastric cancer population, including those with low or negative PD-L1 expression. Akeso plans to continue exploring cadonilimab's global clinical value.

Gastric cancer remains one of the most common malignancies worldwide, with nearly one million new cases each year. China alone accounts for about half of these cases and deaths. For patients ineligible for surgery or with metastatic gastric cancer, cadonilimab combination therapy is expected to offer a more effective treatment option compared to existing immunotherapies.

Cadonilimab's approval marks a significant advancement in the treatment landscape for advanced gastric cancer, providing hope for better patient outcomes and advancing global immunotherapy development.