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CheckMate 9DW

Dual immune checkpoint blockade gave the longest median survival yet seen in a first-line liver cancer trial.

Median OS 23.7 vs 20.6 months (HR 0.79); ORR 36% vs 13%; median duration of response 30.4 vs 12.9 months (Lancet 2025). FDA approval April 2025. Higher immune-related toxicity than single-agent regimens.

Setting
First-line unresectable HCC: nivolumab + ipilimumab vs lenvatinib or sorafenib
Phase
Phase 3
Sponsor
BMS
Registry
Headline result
OS 23.7 vs 20.6 months, HR 0.79; ORR 36% vs 13%.
Reported
2024
Enrolled
668

Outcomes

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In plain words
What these results mean for people, not percentages
668 people took part
Overall survivalprimarysurvival endpoint
  • Median 23.7 vs 20.6 months with Nivolumab + ipilimumab compared with Lenvatinib or sorafenib; about 3.1 months longer for half the group.
  • A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
  • Put another way, the treated group had about 21 percent lower chance of the event at any given time (hazard ratio 0.79, likely range 0.65 to 0.96).
  • Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
Objective response rateresponse endpoint
  • 36 vs 13 out of 100 had their tumour shrink with Nivolumab + ipilimumab compared with Lenvatinib or sorafenib; 23 more per 100.
  • Roughly one extra person helped for every 4 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
  • The p-value (<0.0001) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
  • A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
Be careful
  • These results apply to the people the trial enrolled: First-line unresectable HCC: nivolumab + ipilimumab vs lenvatinib or sorafenib. People in a different situation may not see the same effect.

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.

668 participants enrolled.

Overall survivalprimary
HR 0.79 (0.65–0.96) · p = 0.018
Nivolumab + ipilimumab
23.7 mo
Lenvatinib or sorafenib
20.6 mo
Objective response rate
· p <0.0001
Nivolumab + ipilimumab36 of 100
Lenvatinib or sorafenib13 of 100
EndpointArmnValueHR (95% CI)pSource
Overall survivalprimaryNivolumab + ipilimumab33523.7 months0.79 (0.65–0.96)0.018
Lenvatinib or sorafenib33320.6 months
Objective response rateNivolumab + ipilimumab36%<0.0001
Lenvatinib or sorafenib13%

Connected

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