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Phase II Data of Cadonilimab Regimen as Neoadjuvant Therapy for Resectable Gastric Cancer Presented at ESMO Asia 2025
Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that data from the Phase II study (COMPASSION-25) for its first-in-class PD-1/CTLA-4 bispecific antibody, cadonilimab, in combination with SOX regimen (oxaliplatin + tegafur/gimeracil/oteracil) as neoadjuvant therapy for resectable gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, was presented at the 2025 ESMO Asia Congress.
About this update from Akeso, Inc.
[{"type":"text","content":"HONG KONG, Dec. 9, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that data from the Phase II study (COMPASSION-25) for its first-in-class PD-1/CTLA-4 bispecific antibody, cadonilimab, in combination with SOX regimen (oxaliplatin + tegafur/gimeracil/oteracil) as neoadjuvant therapy for resectable gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, was presented at the 2025 ESMO Asia Congress.","length":457,"tagName":"p"},{"type":"text","content":"Currently, Akeso is running the pivotal Phase III study (AK104-310/COMPASSION-33) investigating cadonilimab combined with the SOX regimen for perioperative treatment of resectable G/GEJ adenocarcinoma. This regimen is expected to further push the efficacy boundaries beyond existing single-target immunotherapies and establish a new standard for perioperative immunotherapy in gastric cancer.","length":392,"tagName":"p"},{"type":"text","content":"Promising Pathologic Complete Response (pCR) Rate","length":49,"tagName":"p"},{"type":"text","content":"Among all evaluable patients, the overall pCR rate was 28.6%. Notably, in patients receiving the cadonilimab Q3W dosing regimen, the pCR rate reached 50.0%. pCR, defined as the absence of viable tumor cells in both the primary tumor site and regional lymph nodes upon surgical resection, is considered the "gold standard" surrogate endpoint for evaluating neoadjuvant treatment efficacy and predicting long-term survival benefits.","length":440,"tagName":"p"},{"type":"text","content":"High Rate of Major Pathologic Response (MPR)","length":44,"tagName":"p"},{"type":"text","content":"The overall MPR rate (defined as ≤10% residual viable tumor cells) across all evaluable patients was 71.4%. For the cadonilimab Q3W regimen, the MPR rate was as high as 85.7%. This suggests that the cadonilimab-based regimen induces substantial tumor regression in the majority of patients.","length":290,"tagName":"p"},{"type":"text","content":"100% R0 Resection Rate","length":22,"tagName":"p"},{"type":"text","content":"All patients who underwent surgery achieved an R0 resection (microscopically margin-negative resection), providing a solid foundation for curative intent and potentially reducing the risk of recurrence.","length":202,"tagName":"p"},{"type":"text","content":"Significant Tumor Downstaging...