HONG KONG, March 4, 2026 – Akeso, Inc. (9926.HK) announced long-term survival data from a pivotal Phase II study in China evaluating cadonilimab as a monotherapy for recurrent or metastatic cervical cancer (R/M CC) patients who have progressed after platinum-based chemotherapy. The findings, presented at the 27th European Congress on Gynaecological Oncology (ESGO 2026), demonstrate the potential for sustained disease control and improved survival outcomes with the treatment.
The data, presented by Professor Wu Xiaohua of Fudan University Shanghai Cancer Center, the study’s principal investigator, focused on a stratified analysis of all 99 efficacy-evaluable patients with a median follow-up of 26.5 months. The analysis quantified the correlation between the depth of tumor response and long-term survival benefits associated with cadonilimab.
Patients achieving a complete response (CR) experienced a median overall survival (OS) that was not reached, with a 24-month OS rate of 100.0% (p = 0.0002). Their median progression-free survival (PFS) was also not reached, with a 12-month PFS rate of 84.6% (p < 0.0001). For patients achieving a partial response (PR), the median OS also remained unreached, with a 24-month OS rate of 63% (p = 0.0002). The median PFS for this group was 11.17 months, with a 12-month PFS rate of 47.3% (p < 0.0001).
The median time to response (mTTR) was comparable between the CR and PR groups, at 1.84 and 1.87 months respectively. The median duration of response (mDoR) was significantly longer in the CR patients (p = 0.035).
The study included patients with varying levels of PD-L1 expression, with over 18% having PD-L1 CPS < 1, and 36% having received two or more prior lines of systemic therapy. Results showed a median OS of 17.5 months (95% confidence interval: 11.4 months to not estimable) across the overall population. Updated data indicated durable survival benefits for both PD-L1 positive and negative patients, with 18-month and 24-month OS rates of 47.8% and 40.9%, respectively.
Cadonilimab, approved in China for first-line gastric cancer, first-line cervical cancer, and recurrent/metastatic cervical cancer, is a bispecific antibody targeting both PD-1 and CTLA-4. Akeso states the drug addresses clinical gaps by demonstrating efficacy across all levels of PD-L1 expression. The company highlights its potential to overcome resistance seen with current PD-1/L1 agents, particularly in “cold tumors” and those resistant to immunotherapy.
Akeso is currently evaluating cadonilimab in 11 registrational/Phase III studies across various cancer indications, including a global Phase III trial in first-line gastric cancer and a global registrational trial in IO-resistant hepatocellular carcinoma, as announced in September 2025. The company intends to pursue both internal development and external collaborations to accelerate global access to the drug.
