#Hong Kong #ESMO Asia #Akeso #Cadonilimab

Overview

The Phase II study on cadonilimab, presented at ESMO Asia 2025, showcases powerful findings for treating resectable gastric cancer. Conducted by Akeso, Inc., this research dives into the effectiveness of cadonilimab—a PD-1/CTLA-4 bispecific antibody—paired with the SOX regimen, which combines oxaliplatin with tegafur/gimeracil/oteracil. This innovative treatment aims to set a new standard in perioperative immunotherapy for gastric cancer, radically pushing the boundaries established by traditional single-target immunotherapy.

Study Highlights

The Phase II study named COMPASSION-25 evaluated the impact of cadonilimab in combination with SOX on patients with resectable gastric or gastroesophageal junction adenocarcinoma. Among the notable findings:
- Pathologic Complete Response (pCR): The study revealed an overall pCR rate of 28.6%. This rate significantly increased to 50.0% for patients administered the cadonilimab every three weeks (Q3W). pCR, which indicates the absence of viable tumor cells post-surgery, is considered a critical benchmark for assessing the success of neoadjuvant treatments.
- Major Pathologic Response (MPR): The MPR rate measured across all patients reached 71.4%, with 85.7% for those on the Q3W regimen. MPR signifies the presence of 10% or fewer residual viable tumor cells, thus reflecting substantial tumor regression.
- R0 Resection Rate: Impressively, all surgery candidates achieved R0 resection, ensuring that no microscopic traces of cancer remained, thereby bolstering the potential for a cure and diminishing the chances of recurrence.
- Tumor Downstaging: The study noted that 85.7% of evaluable patients experienced downstaging of their primary tumor, while nodal downstaging was accomplished by 75.0%. Such results point to cadonilimab's efficacy in lessening tumor load and enhancing surgical conditions.

Safety Profile

Observations related to safety were consistent with known profiles of both the SOX regimen and immune checkpoint inhibitors. No unforeseen safety issues emerged, indicating a generally acceptable and manageable safety profile. Thus, clinicians can have more confidence in administering this treatment scheme.

Significance in Gastric Cancer Treatment

Currently, standard treatment for resectable gastric cancers leans heavily on chemotherapy alone. However, due to its limited scope of efficacy, advancements like cadonilimab are essential. The dual blockade mechanism of cadonilimab activates the immune system comprehensively, delivering a robust anti-tumor response unlike conventional PD-1/L1 therapies.
Akeso asserts that the clinical advantages of cadonilimab in gastric cancer are well-founded. Beyond the ongoing Phase III studies for perioperative settings, cadonilimab has achieved selections for first-line treatment of advanced gastric cancer, through which patients could experience survival benefits regardless of PD-L1 expression levels. Moreover, a trial that combines cadonilimab with pulocimab for immune-resistant advanced gastric cancer is anticipated.

Future Prospects

The promising outcomes of cadonilimab signal a hopeful evolution in gastric cancer therapy. More pivotal studies aim to widen the horizon for this innovative treatment, making it applicable not just for unmanageable conditions but extending usable strategies to earlier stages of cancer as well.
Akeso, founded in 2012, stands at the forefront of biopharmaceutical innovation, offering a multipronged approach to tackle various health issues, cementing its position in the global market.

Conclusion

In a realm where cancer treatment is continually transforming, the Phase II data for cadonilimab offers a beacon of hope. With robust clinical evidence, Akeso is committed to advancing the standard of care for patients battling gastric cancer. Future studies will continue to refine and expand treatment modalities, ultimately paving the way for improved patient outcomes.