#Hong Kong #gastric cancer #Akeso #Cadonilimab

Cadonilimab’s Impact on Advanced Gastric Cancer

On October 19, 2025, Akeso (9926.HK) showcased the final findings from their pivotal COMPASSION-15/AK104-302 study at the European Society of Medical Oncology Congress, ESMO 2025. This Phase III clinical trial examined the potential of cadonilimab, a groundbreaking PD-1/CTLA-4 bispecific antibody. The study specifically evaluated its combination with oxaliplatin and capecitabine as a first-line treatment option for patients with unresectable, locally advanced, or metastatic gastric and gastroesophageal junction (G/GEJ) adenocarcinoma. The significant findings presented by Professor Shen Lin, a leading investigator at Peking University Cancer Hospital, make a compelling case for incorporating cadonilimab into standard treatment protocols.

The COMPASSION-15 study's findings, with a median follow-up duration of 33.9 months, unveiled noteworthy long-term survival benefits associated with the cadonilimab treatment plan. The data illustrated a prominent reduction in mortality risk among patients treated with cadonilimab compared to the control cohort, a trend that persisted across all evaluated subgroups based on PD-L1 expression levels.

Key Findings from COMPASSION-15

In the final analysis, the results revealed a promising 39% decrease in mortality risk for patients receiving cadonilimab (Overall Survival Hazard Ratio (OS HR) = 0.61) versus the control group. This is an enhancement over the previously reported interim analysis in January 2025, which indicated an OS HR of 0.66 with a median follow-up of just 18.7 months. The cadonilimab regimen demonstrated superior efficacy, particularly in specific PD-L1 expression patient populations.

For example, when focusing on the population with PD-L1 CPS ≥5, participants showed a striking 51% reduction in mortality risk (OS HR = 0.49; p < 0.001). Meanwhile, in those with PD-L1 CPS <5, the treatment still showcased a significant 24% reduction (OS HR = 0.76; p = 0.019), further supporting the drug's utility across a diverse patient landscape.

Moreover, the research did not reveal any new safety concerns linked to the cadonilimab regimen during the extended follow-up period, thus maintaining a favorable safety profile.

Noteworthy Patient Demographics

The COMPASSION-15 trial has an important demographic facet: it included a higher number of low PD-L1 expression patients compared to previous studies involving immune checkpoint inhibitors for first-line gastric cancer. Specifically, nearly 50% of patients had PD-L1 CPS < 5, and just over 23% had negative PD-L1 expression. Earlier research had indicated limited efficacy of PD-1/L1 inhibitors in cases with such expressions, making cadonilimab a vital new treatment option.

Regulatory Milestones

In a notable achievement, the cadonilimab was officially approved by the NMPA in September 2024 for the first-line treatment of advanced gastric cancer. This approval not only marks an important milestone for Akeso but also offers patients a valuable new immunotherapy alternative. Furthermore, cadonilimab has been recognized in the 2025 CSCO Gastric Cancer Guidelines as the only Category I recommendation for first-line immunotherapy, regardless of a patient’s PD-L1 status, underscoring its significant clinical impact.

Conclusion

The final analysis presented at ESMO 2025 undeniably strengthens cadonilimab's position as a foremost option in treating advanced gastric cancer. With the data indicating profound survival benefits across various patient demographics, this bispecific antibody not only provides a beacon of hope for clinicians and patients alike but also enhances the paradigm of care in oncology. As Akeso continues to innovate and expand its portfolio, the ongoing integration of cadonilimab into clinical practice could yield significant transformations in patient outcomes, marking a new era in gastric cancer treatment.

For ongoing updates about Akeso and its developments, interested parties are encouraged to visit their official website or follow them on LinkedIn.