China’s NMPA Approves Cadonilimab Plus Chemo With/Without Bevacizumab in Cervical Cancer

Cadonilimab plus chemotherapy in cervical cancer|

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China’s National Medical Products Administration (NMPA) has approved cadonilimab in combination with platinum-based chemotherapy with or without bevacizumab (Avastin) for the first-line treatment of patients with persistent, recurrent, or metastatic cervical cancer.¹

Findings from the phase 3 COMPASSION-16 study (AK104-303; NCT04982237) supported the approval. Interim data published in The Lancet and subsequently shared in a presentation during the 2025 ASCO Annual Meeting showed that the cadonilimab combination regimen produced a notable efficacy benefit in patients with tumors with a PD-L1 combined positive score of less than 1, which comprised 27.9% of patients in the treatment group and 24.2% of the control group.^1,2 The study met both progression-free survival (PFS) and overall survival (OS) end points: the median PFS was 13.3 months vs 8.2 months in the cadonilimab (n = 222) vs placebo arms (n = 223; HR, 0.62; 95% CI, 0.49-0.79; P < .0001) and the median OS was not reached vs 22.8 months in these respective groups (HR, 0.64; 95% CI, 0.48-0.86; P = .0011).^2,3

Subgroup analyses from COMPASSION-16 were shared in the same ASCO presentation and indicated that both PD-L1-positive and PD-L1-negative populations experienced benefit from the cadonilimab regimen regardless of bevacizumab inclusion.³ Clinically meaningful improvements in PFS and OS with the cadonilimab regimen were observed in all stratification subgroups and were consistent with the overall patient population; however, the regimen demonstrated more pronounced benefit in prespecified subgroups of patients who received prior concurrent chemoradiotherapy (CCRT), no exposure to bevacizumab, and those age 65 years or older.

“COMPASSION-16 is the first phase 3 study focused on first-line cervical cancer patients in China, with internationally recognized data,” Xiaohua Wu, MD, the principal investigator of COMPASSION-16 and a professor at the Fudan University Shanghai Cancer Center in China, stated in a news release.¹ “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.”

COMPASSION-16 was a randomized, placebo-controlled, multicenter double-blind trial enrolling patients with persistent, recurrent or metastatic cervical cancer who had received no prior systemic therapy and had an ECOG performance status of 0 or 1.³ Patients could have the following histologic subtypes: squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.

Eligible patients were stratified according to prior CCRT and use of bevacizumab and randomly assigned 1:1 to the cadonilimab group vs placebo group. Patients received 10 mg/kg of cadonilimab or placebo, plus 175 mg/m² of paclitaxel and 50 mg/m² of cisplatin or carboplatin area under the curve 4-5, with or without 15 mg/kg of bevacizumab every 3 weeks for 6 cycles. This was followed by maintenance therapy with cadonilimab or placebo, with or without bevacizumab, administered every 3 weeks. Treatment continued until disease progression, unacceptable toxicity, or 2 years of treatment with cadonilimab/placebo were completed.

The study’s primary end points were PFS assessed by blinded independent review per RECIST 1.1 criteria and OS. Secondary end points included PFS by investigator assessment, overall response rate, duration of response, disease control rate, time to response, and safety.

In addition to its approval in first-line cervical cancer, cadonilimab is indicated for first-line advanced gastric cancer as well as relapsed or metastatic cervical cancer that has progressed on or after platinum-based chemotherapy.¹ Cadonilimab is currently included in 16 authoritative clinical treatment guidelines and consensus documents across various oncology indications, such as gastric cancer, gynecological cancers, liver cancer, esophageal cancer, and nasopharyngeal cancer.

Cadonilimab is being evaluated in over 30 ongoing phase 2 and 3 clinical trials, including studies in gastric cancer, lung cancer, liver cancer, cervical cancer, and pancreatic cancer, across different disease stages and subtypes.

“Cadonilimab has demonstrated a significant survival benefit for [patients with] cervical cancer across all-comer populations in both clinical trials and real-world settings,” Yu (Michelle) Xia, PhD, founder, chairwoman, president, and chief executive officer of Akeso, commented in the news release. “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 antitumor effect of 2 immune checkpoint targets, PD-1 and CTLA-4, while producing meaningfully lower immune [adverse] 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 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."

References

1. 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. News release. Akeso. June 5, 2025. Accessed June 5, 2025. https://www.akesobio.com/en/media/akeso-news/250605/
2. Wu X, Sun Y, Yang H, et al. Cadonilimab plus platinum-based chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer (COMPASSION-16): a randomised, double-blind, placebo-controlled phase 3 trial in China. Lancet. 2024;404(10463):1668-1676. doi:10.1016/S0140-6736(24)02135-4
3. Sun Y, Yang H, Lou H, et al. Cadonilimab plus platinum-based chemotherapy ± bevacizumab for persistent, recurrent, or metastatic cervical cancer: subgroup analyses of COMPASSION-16. J Clin Oncol.2025;43(suppl 16):5509. doi:10.1200/JCO.2025.43.16_suppl.5509