Akeso's PD-1/CTLA-4 Bispecific Antibody Cadonilimab Approved for First-Line Treatment of Cervical Cancer in All-Comer Populations--Third Approved Indication for Cadonilimab

HONG KONG, June 4, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is pleased to announce that the National Medical Products Administration (NMPA) has approved the company's first- in-class PD-1/CTLA-4 bispecific antibody, cadonilimab, for the first-line treatment of persistent, recurrent, or metastatic cervical cancer, in combination with platinum-based chemotherapy, with or without bevacizumab. The NMPA approval marks the third approved indication for cadonilimab.

With the approval for first-line cervical cancer, cadonilimab has achieved comprehensive coverage for the treatment of advanced cervical cancer, offering an innovative treatment option for patients across all stages of advanced cervical cancer. This approval addresses the critical unmet need for immune-based therapies for first-line cervical cancer patients in China and represents a significant step forward in the treatment of this disease. In addition to the treatment for first-line cervical cancer, cadonilimab is also approved for first-line treatment of advanced gastric cancer, and for the treatment of relapsed or metastatic cervical cancer who progressed on or after platinum-based chemotherapy.

The approval for cadonilimab's use in combination with chemotherapy (with or without bevacizumab) in first-line cervical cancer is based on the clinical data from the Phase III COMPASSION-16 (AK104-303) study. In COMPASSION-16, the cadonilimab combination regimen showed a notable efficacy benefit in patients with tumors that have a negative PD-L1 expression (CPS <1), comprising 27.9% of the population in the treatment group, compared to 24.2% in the control group. The study met both progression-free survival (PFS) and overall survival (OS) endpoints, demonstrating significant improvements in both endpoints for patients treated with the cadonilimab regimen compared to standard therapies in the first-line setting for cervical cancer.

Subgroup analyses from COMPASSION-16 study indicated that both PD-L1-positive and PD-L1-negative populations, regardless of bevacizumab inclusion, benefited from the treatment. The results of the COMPASSION-16 trial were presented as a Late-Breaking Abstract (LBA) at the 2024 International Gynecologic Cancer Society (IGCS) Global Meeting, and were subsequently published in The Lancet and later reported again in Nature Reviews Clinical Oncology.

Cervical cancer remains one of the most prevalent and deadly cancers among women, with a 5-year survival rate of approximately 17.0% for patients in the advanced stages. In 2022, China reported 150,700 new cervical cancer cases, resulting in the second-largest burden of cervical cancer worldwide.

Professor Wu Xiaohua, the principal investigator of COMPASSION-16 and a professor at the Fudan University Shanghai Cancer Center, stated, "COMPASSION-16 is the first Phase III study focused on first-line cervical cancer patients in China, with internationally recognized data. We've seen cadonilimab's breakthrough efficacy in both recurrent and metastatic cervical cancer, showing high effectiveness, low toxicity, and strong anti-tumor activity regardless of PD-L1 expression. This first-line combination therapy sets a new standard in cancer treatment and is expected to accelerate the clinical adoption of cadonilimab, benefiting more patients."

Dr. Xia Yu, founder, chairwoman, president, and CEO of Akeso, commented, "Cadonilimab has demonstrated significant survival benefit for cervical cancer patients across all-comer populations in both clinical trials and real-world settings. For patients who respond to PD-1/L1 monotherapy, cadonilimab offers superior therapeutic outcomes over PD-1/PD-L1 therapies. For patients with low PD-L1 expression or those who are resistant to PD-1 monotherapy, cadonilimab provides significant clinical benefits over current treatment options. Cadonilimab takes advantage of the synergistic anti-tumor effect of two immune checkpoint targets, PD-1 and CTLA-4, while producing a meaningfully lower immune side effects than the combination of PD-1 and CTLA-4 antibody therapies.  This approval represents another advancement of immunotherapy 2.0 in cervical cancer therapy, offering clinically meaningful improvements in disease treatment and in patient quality of life. This achievement reflects Akeso's robust innovation capabilities and commitment to cancer patient outcomes, and it also aligns with our corporate vision to become a global leader in developing next-generation therapeutic antibodies for patients worldwide. "

Currently, cadonilimab is included in 16 authoritative clinical treatment guidelines and consensus documents across multiple oncology indications, including gastric cancer, gynecological cancers, liver cancer, esophageal cancer, and nasopharyngeal cancer. Beyond the three approved indications, cadonilimab is also currently in over 30 Phase II and III clinical trials for other cancer types, which includes different stages of disease progression as well as different cancer sub-types.  These include clinical studies on gastric cancer, lung cancer, liver cancer, cervical cancer, and pancreatic cancer.

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. 

SOURCE Akeso, Inc.