Cadonilimab Achieves 100% 24-Month OS in Complete Responders in R/M Cervical Cancer Based on Long-Term Phase II Results

HONG KONG, March 4, 2026 /PRNewswire/ -- 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.

About Akeso

Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has established a robust R&D innovation ecosystem centered on its proprietary Tetrabody bispecific antibody platform, ADC (Antibody-Drug Conjugate) technologies, siRNA/mRNA modalities, and cell therapies. Supported by a global-standard GMP manufacturing infrastructure and a highly efficient, integrated commercialization model, the company has evolved into a globally competitive biopharmaceutical focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 26 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise.

Forward-Looking Statements

This announcement by Akeso, Inc. (9926.HK, "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.

SOURCE Akeso, Inc.