CARES-310
A PD-1 antibody plus an oral anti-VEGF pill beat sorafenib on survival, one of the largest benefits seen in liver cancer.
OS 23.8 vs 15.2 months (HR 0.62, updated); PFS 5.6 vs 3.7 months; ORR 25% vs 6%. Global trial with ~80% Asian enrolment. Approved in China; three FDA CRLs over manufacturing.
Setting
First-line unresectable HCC: camrelizumab + rivoceranib vs sorafenib
Phase
Phase 3
Sponsor
Jiangsu Hengrui / Elevar
Registry
Headline result
OS 23.8 vs 15.2 months, HR 0.62.
Reported
2023
Enrolled
543
In plain words
What these results mean for people, not percentages
Overall survivalprimarysurvival endpoint
- Median 23.8 vs 15.2 months with Camrelizumab + rivoceranib compared with Sorafenib; about 8.6 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 38 percent lower chance of the event at any given time (hazard ratio 0.62).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
Progression-free survivalprimarysurrogate endpoint
- Median 5.6 vs 3.7 months with Camrelizumab + rivoceranib compared with Sorafenib; about 1.9 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 48 percent lower chance of the event at any given time (hazard ratio 0.52).
- 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.
Be careful
- These results apply to the people the trial enrolled: First-line unresectable HCC: camrelizumab + rivoceranib vs 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.
543 participants enrolled.
Overall survivalprimary
HR 0.62
Camrelizumab + rivoceranib
23.8 mo
Sorafenib
15.2 mo
Progression-free survivalprimary
HR 0.52
Camrelizumab + rivoceranib
5.6 mo
Sorafenib
3.7 mo
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Camrelizumab + rivoceranib | 272 | 23.8 months | 0.62 | — | — |
| Sorafenib | 271 | 15.2 months | ||||
| Progression-free survivalprimary | Camrelizumab + rivoceranib | — | 5.6 months | 0.52 | — | — |
| Sorafenib | — | 3.7 months |