Subgroup Analysis of Cadonilimab as First-Line Therapy for Advanced Cervical Cancer Reported in an Oral Presentation at ASCO 2025

HONG KONG, June 16, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company")  presented the subgroup analysis data from the Phase III COMPASSION-16 trial, evaluating cadonilimab, a first-in-class PD-1/CTLA-4 bispecific antibody, in the first-line treatment of advanced, recurrent, or metastatic cervical cancer. The data was featured as an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

The subgroup analysis demonstrated that cadonilimab treatment significantly improved progression-free survival (PFS) and overall survival (OS) across different  patient subgroups, including: levels of PD-L1 expression, prior treatment with concurrent chemoradiotherapy (CCRT), bevacizumab use, and age of the patients (≥65, <65). These results  further demonstrate the clinical value and the global women's health impact  of cadonilimab in advancing thetreatment standart for advanced cervical cancer.

The results of the COMPASSION-16 study were previously published in The Lancet and presented at the 2024 International Gynecologic Cancer Society (IGCS) Global Meeting. The Lancet publication and the IGCS presentation disclosed that cadonilimab, in combination with platinum-based chemotherapy (with or without bevacizumab), significantly extended survival in both PD-L1-positive and PD-L1-negative patient populations (mOS HR 0.64, P=0.0011), and reduced the risk of disease progression and death (mPFS HR 0.62, P<0.0001).

At the 2025 ASCO annual meeting, the study's principal investigator, Professor Xiaohua Wu from the Fudan University Shanghai Cancer Center, presented the subgroup analysis findings from the COMPASSION-16 study, with data cut-off as of April 30, 2024.

Key Findings:

Significant Reduction in Mortality Risk Across All Patient Subgroups, Regardless of PD-L1 Expression:

• In the CPS<1 group, mPFS was 12 months in the cadonilimab arm vs. 8.2 months in the control arm (HR=0.65), and mOS was not reached in the cadonilimab arm vs. 25.3 months in the control arm (HR=0.77).
• In the CPS≥1 group, mPFS was 14.7 months in the cadonilimab arm vs. 8.3 months in the control arm (HR=0.62), and mOS was not reached in the cadonilimab arm vs. 22.7 months in the control arm (HR=0.69).
• In the CPS≥10 group, mPFS was 17.1 months in the cadonilimab arm vs. 8.1 months in the control arm (HR=0.54), and mOS was not reached in the cadonimab arm vs. 29 months in the control arm (HR=0.68).

Clinical Benefit in PFS and OS Regardless of Prior CCRT Treatment:

• In patients previously treated with CCRT, mPFS was 16.1 months in the cadonilimab arm vs. 7.9 months in the control arm (HR=0.55), and mOS was not reached in the cadonilimab arm vs. 22.8 months in the control arm (HR=0.54).

Clinical Benefit in PFS and OS Regardless of Bevacizumab Use:

• In  real-world settings, approximately 40% of patients are considered unsuitable for bevacizumab due to underlying conditions or bleeding/perforation risks. Cadonilimab demonstrated clinically meaningful improvements in both PFS and OS, whether or not bevacizumab was included in the treatment.
• In the bevacizumab-naive groups, mPFS was 11.7 months in the cadonilimab arm vs. 6.7 months in the control arm (HR=0.44), and mOS was 28.2 months in the cadonilimab arm vs. 15.1 months in the control arm (HR=0.5).

Improvement in PFS and OS Across Age Subgroups, with Greater Efficacy in Patients ≥65 Years:

• In patients < 65 years, mPFS was 13.5 months in the cadonilimab arm vs. 9.5 months in the control arm (HR=0.68), and mOS was not reached in the cadonilimab arm vs. 25.3 months in the control arm (HR=0.69).
• In patients ≥ 65 years, mPFS was 12 months in the cadonilimab arm vs. 7.4 months in the control arm(HR=0.39), and mOS was 26.6 months in the cadonilimab arm vs. 15.1 months in the control arm (HR=0.49).

Cadonilimab Combined with Platinum Agents (Cisplatin/Carboplatin) Improves PFS and OS:

• In the cisplatin arm, mPFS was 14.7 months in the cadonilimab arm vs. 8.1 months in the control arm (HR=0.49), and mOS was not reached in the cadonilimab arm vs. 23.9 months in the control arm (HR=0.43).
• In the carboplatin arm, mPFS was 12 months in the cadonilimab arm vs. 8.2 months in the control arm (HR=0.72), and mOS was 27.8 months in the cadonilimab arm vs. 22.8 months in the control arm (HR=0.82).

In June 2022, cadonilimab was granted approval by the China National Medical Products Administration (NMPA) for the treatment of recurrent or metastatic cervical cancer in patients who had previously failed platinum-based chemotherapy. This indication has since been included in the national reimbursement list. In September 2024, the use of cadonilimab in first-line treatment for advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma  was approved by the NMPA. The use of cadonilimab in first-line treatment for advanced, recurrent, or metastatic cervical cancer was approved by the NMPA in May 2025. In addition, cadonilimab is currently being evaluated in nearly 30 registrational/Phase III and Phase II clinical trials across a number of high-incidence cancers. Preliminary results show that cadonilimab demonstrates clinical benefit for patient populationsin both the positive and the negative PD-L1 expression groups, marking a significant advancement over existing immunotherapies.

Forward-Looking Statement of Akeso, Inc.

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.