# COMPASSION-16 / AK104-303

Source: https://onco.cc/trials/compassion-16/  
OnCo record `compassion-16` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A two-headed antibody that blocks two immune brakes at once extended survival in advanced cervical cancer regardless of PD-L1 status.

## Summary

COMPASSION-16, also AK104-303, trial NCT04982237 sponsored by Akeso and published in the Lancet in 2024, showed that cadonilimab, a two-headed antibody that blocks PD-1 and CTLA-4 at once, added to first-line platinum and paclitaxel with or without bevacizumab extends survival in persistent, recurrent or metastatic cervical cancer in China regardless of PD-L1 status. It randomised 445 patients and met its primary progression-free and overall survival endpoints with benefit in both PD-L1-positive and PD-L1-negative subgroups, leading to NMPA approval of the first-line combination in 2024. OnCo links it to cervical cancer, bispecific antibodies, PD-1 and CTLA-4 as targets, cadonilimab, bevacizumab and Akeso. It was not approved outside China by 2026, and whether a bispecific offers more than PD-1 blockade alone in PD-L1-negative disease is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT04982237
- Phase: 3
- Setting: Persistent, recurrent, or metastatic cervical cancer, first line (China): cadonilimab (PD-1×CTLA-4 bispecific) + platinum-paclitaxel ± bevacizumab vs placebo + chemotherapy ± bevacizumab
- Sponsor: Akeso
- Enrolled: 445
- Result: OS HR 0.64; PFS HR 0.62.
- Outcomes: Progression-free survival: Cadonilimab + chemo ± bev vs Placebo + chemo ± bev, HR 0.62; Overall survival: Cadonilimab + chemo ± bev vs Placebo + chemo ± bev, HR 0.64

## Sources

- ClinicalTrials.gov NCT04982237: https://clinicaltrials.gov/study/NCT04982237
- Lancet 2024: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02135-4/abstract

## Connected records

- cancers: [Cervical cancer](https://onco.cc/cancers/cervical/), [Recurrent or metastatic cervical cancer](https://onco.cc/cancers/recurrent-metastatic-cervical-cancer/)
- technologies: [Bispecific antibodies](https://onco.cc/technologies/bispecific-antibody/)
- targets: [CTLA-4](https://onco.cc/targets/ctla4/), [PD-1](https://onco.cc/targets/pd1/)
- drugs: [Bevacizumab](https://onco.cc/drugs/bevacizumab/), [Cadonilimab](https://onco.cc/drugs/cadonilimab/), [Cisplatin](https://onco.cc/drugs/cisplatin/), [Paclitaxel / nab-paclitaxel](https://onco.cc/drugs/paclitaxel/)
- companies: [Akeso](https://onco.cc/companies/akeso/)

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JSON: https://onco.cc/api/v1/entities/compassion-16.json