OnCo
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COMPASSION-16 / AK104-303

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

PFS HR 0.62 and OS HR 0.64 (Lancet 2024), with benefit in both PD-L1-positive and PD-L1-negative subgroups. NMPA approved the first-line combination in 2024 (second-line monotherapy since 2022). It was not approved outside China by 2026.

Setting
Persistent, recurrent, or metastatic cervical cancer, first line (China): cadonilimab (PD-1×CTLA-4 bispecific) + platinum-paclitaxel ± bevacizumab vs placebo + chemotherapy ± bevacizumab
Phase
Phase 3
Sponsor
Akeso
Registry
Headline result
OS HR 0.64; PFS HR 0.62.
Reported
2024
Enrolled
445

Outcomes

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In plain words
What these results mean for people, not percentages
445 people took part
Progression-free survivalprimarysurrogate endpoint
  • The treated group had about 38 percent lower chance of the event at any given time (hazard ratio 0.62).
  • The absolute difference, how many more people out of 100 were helped, is not reported here.
  • This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
Overall survivalprimarysurvival endpoint
  • The treated group had about 36 percent lower chance of the event at any given time (hazard ratio 0.64).
  • The absolute difference, how many more people out of 100 were helped, is not reported here.
  • Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
Be careful
  • These results apply to the people the trial enrolled: Persistent, recurrent, or metastatic cervical cancer, first line (China): cadonilimab (PD-1×CTLA-4 bispecific) + platinum-paclitaxel ± bevacizumab vs placebo + chemotherapy ± bevacizumab. People in a different situation may not see the same effect.
  • The trial selected people by a biomarker (PD-1); the result should not be assumed for people whose cancer does not have it.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

445 participants enrolled.

Progression-free survivalprimary
HR 0.62 (0.49–0.8)

Numbers not yet public.

Source
Overall survivalprimary
HR 0.64 (0.48–0.86)

Numbers not yet public.

Source
EndpointArmnValueHR (95% CI)pSource
Progression-free survivalprimaryCadonilimab + chemo ± bev2220.62 (0.49–0.8)link
Placebo + chemo ± bev223
Overall survivalprimaryCadonilimab + chemo ± bev0.64 (0.48–0.86)link
Placebo + chemo ± bev

Connected

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