News|Articles|March 5, 2026

Cadonilimab Shows Durable Survival in Advanced Cervical Cancer Study

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Key Takeaways

Complete response correlated with exceptional durability, with unreached median OS/PFS, 100% 24-month OS, and 84.6% 12-month PFS, suggesting profound long-term disease control in select patients.
Partial responders achieved unreached median OS with 63% 24-month OS and median PFS 11.17 months, indicating clinically meaningful benefit despite less deep radiographic response.
Activity was observed regardless of PD-L1 status, including CPS <1 patients, supporting potential utility beyond PD-L1–selected populations in the post-platinum recurrent/metastatic setting.
The cohort was clinically heterogeneous, with 36% receiving ≥2 prior systemic lines, and overall outcomes showed median OS 17.5 months with 24-month OS 40.9% at 26.5 months follow-up.
Safety details were not provided in the updated disclosure, limiting risk–benefit interpretation despite cadonilimab’s dual PD-1/CTLA-4 bispecific rationale and established China approvals.

Phase 2 COMPASSION-03 data showed cadonilimab produced durable survival in patients with recurrent or metastatic cervical cancer after platinum chemotherapy.

Long-term results from a phase 2 study presented at the 27th European Congress on Gynaecological Oncology (ESGO 2026) in Hong Kong showed that cadonilimab produced durable survival outcomes in patients with recurrent or metastatic cervical cancer whose disease had progressed after prior platinum-containing chemotherapy, according to a news release from Akeso, Inc.

The updated findings from the COMPASSION-03/AK104-201 trial were presented by Professor Wu Xiaohua from Fudan University Shanghai Cancer Center. The analysis showed that patients who experienced a complete response to cadonilimab had a 24-month overall survival (OS) rate of 100%.

Researchers reported that these long-term data highlight the potential for cadonilimab to support durable disease control and survival in patients with advanced cervical cancer who previously received platinum-based treatment.

What survival outcomes were seen with cadonilimab treatment?

The updated analysis evaluated 99 efficacy-evaluable patients and examined survival outcomes based on best overall response (BOR). Researchers assessed whether the depth of tumor response was associated with longer survival outcomes in patients receiving cadonilimab monotherapy.

Among patients who achieved a complete response (CR), the median OS was not reached. The 24-month OS rate reached 100%. The median progression-free survival (PFS) was also not reached in this group. The 12-month PFS rate was 84.6%.

Patients who achieved a partial response (PR) also experienced encouraging outcomes. In this group, the median OS remained unreached, with a 24-month OS rate of 63%. The median PFS was 11.17 months, and the 12-month PFS rate was 47.3%.

The median time to response was similar between the groups. Among patients who achieved a complete response, the median time to response was 1.84 months. Among those with a partial response, the median time to response was 1.87 months.

The median duration of response was not reached among patients who achieved a complete response and was longer than the duration observed among patients who achieved a partial response.

Researchers also evaluated outcomes across PD-L1 expression levels. The study showed that cadonilimab produced durable survival outcomes in both PD-L1–positive and PD-L1–negative populations.

Across the overall study population, the median OS was 17.5 months. The long-term follow-up analysis showed 18-month and 24-month OS rates of 47.8% and 40.9%, respectively.

How was the phase 2 COMPASSION-03 trial designed?

The COMPASSION-03 study was a pivotal registrational phase 2 trial evaluating cadonilimab as a single-agent treatment in patients with recurrent or metastatic cervical cancer whose disease progressed after platinum-containing chemotherapy.

The trial included patients with varying treatment histories. More than 18% of enrolled patients had PD-L1 combined positive score (CPS) less than 1, indicating PD-L1–negative disease. Additionally, 36% of patients had received two or more prior lines of systemic therapy before enrolling in the study.

Researchers conducted the updated survival analysis with a median follow-up of 26.5 months.

Cadonilimab is a bispecific antibody that targets both PD-1 and CTLA-4. This dual-targeting approach is designed to preserve the therapeutic effects of both immune pathways while addressing limitations seen with agents that target each pathway individually.

Cadonilimab was commercially launched in 2022 and is currently approved in China for three indications: first-line gastric cancer, first-line cervical cancer and recurrent or metastatic cervical cancer.

The therapy is also being studied in multiple ongoing trials, including 11 registrational phase 3 studies across several tumor types and treatment settings.

What side effects were reported in the study?

The press release presenting the updated phase 2 study results did not report specific safety findings or side effect rates associated with cadonilimab in this analysis.

References

“Cadonilimab Achieves 100% 24-Month OS in Complete Responders in R/M Cervical Cancer Based on Long-Term Phase II Results.” News Release. Akeso Inc.

Editor's note: This article is for informational purposes only and is not a substitute for professional medical advice, as your own experience will be unique. Use this article to guide discussions with your oncologist. Content was generated with AI, reviewed by a human editor, but not independently verified by a medical professional.

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