Akeso’s cadonilimab has outperformed the activity of the current standard of care (SoC) treatment option during a real-world study in first-line gastric or gastroesophageal cancer.
The AK104-302 trial (NCT05008783) put cadonilimab plus chemotherapy agent Xelox (oxaliplatin and capecitabine) head-to-head with chemotherapy alone.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
During the study, cadonilimab plus Xelox met its trial endpoint, offering a statistically significant four-month improvement to overall survival (OS) over Xelox alone – reaching 14.3 months compared to 10.3 months.
The combination of cadonilimab and Xelox also exhibited a progression-free survival (PFS) of 9.3 months, which was significantly longer than the 5.8 months observed in the control cohort who received Xelox alone.
The safety and tolerability profile of cadonilimab plus Xelox was also similar to chemotherapy alone, with no significant differences in the rate of serious adverse events (AEs) observed between the control and treatment groups.
The positive impact of cadonilimab plus chemotherapy was seen in patients with low programmed death ligand 1 (PD-L1) expression – a genotype which is observed in nearly 50% of all advanced gastric cancer patients.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataResults of the AK104-302 study align with the outcome of the Phase III COMPASSION-15 trial (NCT05008783), which was the basis of cadonilimab’s Chinese approval in 2024. Akeso first presented this data at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco.
To further evaluate cadonilimab, Akeso will run the global head-to-head COMPASSION-37 trial, where the company will compare cadonilimab plus chemotherapy to Opdivo (nivolumab) and chemotherapy and as a monotherapy. Akeso got the US Food and Drug Administration (FDA) go-ahead to commence the Phase III trial back in December 2025.
The company is also running a second global registrational study on cadonilimab, which will weigh up the therapy’s potential in patients with immunotherapy-resistant hepatocellular carcinoma.
Harnessing new options for PD-L1-low gastric cancer
Recently, the oncology sector has seen some significant advancements in the treatment paradigm, with targeted therapies gaining approval across a broad range of indications.
While some progress has been made in treating gastric cancer, the SoC still centres around the use of chemotherapy agents, with PD-1-directed immunotherapies like Opdivo, Keytruda (pembrolizumab) and Imfinzi (durvalumab) also being employed when a patient is eligible.
However, PD-1 immunotherapies are not available to a notable proportion of the gastric cancer patient population, as the US Food and Drug Administration (FDA) previously restricted their use to those with PD-L1-positive disease due to the low efficacy of such drugs in PD-L1-low or non-expressors.
This has left patients with low PD-L1 tumour expression with significant unmet needs, as there are no immunotherapies currently approved that are suitable for use.
According to Akeso, cadonilimab could address this challenge by “elevating the standard of cancer immunotherapy and addressing clinical challenges unresolved by single-target PD-1 inhibitors.”
While cadonilimab has already been approved for use in China, Akeso will likely have to replicate these results in global studies to gain US or European approval – meaning the therapy may not reach either of these markets in the near-term.
GlobalData, parent company of Clinical Trials Arena, forecasts that cadonilimab will make $853m for Akeso across the Chinese market in 2031.
