Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that the latest long-term survival analysis data from the China pivotal registrational Phase II study (COMPASSION-03/AK104-201) of cadonilimab as a monotherapy for patients with recurrent or metastatic cervical cancer (R/M CC) who have failed prior platinum-containing chemotherapy, were presented in a late-breaking oral presentation by Professor Wu Xiaohua from Fudan University Shanghai Cancer Center, the Principal Investigator, at the 27th European Congress on Gynaecological Oncology (ESGO 2026).

The long-term survival data of cadonilimab monotherapy in this patient population confirms cadonilimab's ability to convert deep tumor remission into long-term disease control and survival benefits. This study provides clinically meaningful evidence to support its use in the treatment of advanced cervical cancer, offering patients a new therapeutic option that significantly improves survival outcomes.

Best Overall Response (BOR) Analysis Demonstrates Remarkable Survival Benefit

In the updated data presented at the ESGO Congress, with a median follow-up duration of 26.5 months, a BOR-stratified analysis was conducted in all 99 efficacy-evaluable patients. This analysis further quantified the strong correlation between the depth of tumor response and long-term survival benefit associated with cadonilimab treatment.

Among all subjects who achieved a complete response (CR), the median overall survival (OS) was not reached (NR), with a 24-month OS rate of up to 100.0% (nominal p = 0.0002). The median progression-free survival (PFS) was also not reached, with a 12-month PFS rate of 84.6% (nominal p < 0.0001).

In patients achieving partial response (PR), the median OS remained unreached (NR), with a 24-month OS rate of 63% (nominal p = 0.0002). The median PFS was 11.17 months, and the 12-month PFS rate was 47.3% (nominal p < 0.0001).

The median time to response (mTTR) in the CR patients was 1.84 months, comparable to that observed in the PR patients (1.87 months). The median duration of response (mDoR) in the CR patients was not reached and was significantly longer than that in the PR patients (nominal p = 0.035).

Cadonilimab Provides Sustained Long-Term Survival Benefit Irrespective of PD-L1 Expression Status

The COMPASSION-03 study enrolled more than 18% of patients with PD-L1 CPS < 1, and 36% of participants had received ≥2 prior lines of systemic therapy. Study findings demonstrated that cadonilimab monotherapy achieved a median OS of 17.5 months (11.4, NE).

Updated long-term follow-up data showed durable survival benefit across the overall population, including both PD-L1 positive and PD-L1 negative patients, with 18-month and 24-month OS rates of 47.8% and 40.9%, respectively.

The Rising Value of a Foundational IO 2.0 Backbone

Cadonilimab, the world's first approved cancer immunotherapy bispecific antibody that was commercially launched in 2022, has demonstrated its breakthrough clinical value across a large number of approved indications and Phase III trials. Cadonilimab addresses critical clinical gaps by benefiting cancer patients across all levels of PD-L1 expressions, earning strong recognition from clinicians and patients. Importantly, cadonilimab shows superior efficacy versus current standard of care in challenging settings like immunotherapy-resistant tumors and cold tumors that had limited response to PD-1/L1 agents.

This differentiated profile stems from its dual targeting of PD-1 and CTLA-4 with synergistic anti-tumor activity. This novel mechanism preserves the therapeutic benefits of both targets while overcoming their individual limitations. Specifically, the toxicity that restricts the clinical utility of current CTLA-4 monotherapy agents, and the poor response to PD-1/L1 agents in PD-L1 low/negative populations.

Cadonilimab is now approved for three indications in China: first-line gastric cancer, first-line cervical cancer, and recurrent/metastatic cervical cancer. It is under evaluation in 11 registrational/Phase III studies across major first-line tumor indications, various cold tumors, and IO-resistant settings, including a global Phase III trial in first-line gastric cancer and a global registrational trial in IO-resistant hepatocellular carcinoma.

While advancing cadonilimab's global clinical development independently, Akeso remains committed to open collaboration, integrating premier worldwide resources to accelerate international market access and benefit cancer patients worldwide.