LEAP-012
Adding lenvatinib and pembrolizumab to TACE delayed progression by four and a half months but did not help patients live longer.
PFS 14.6 vs 10.0 months (HR 0.66); grade ≥3 adverse events 71% vs 32%; final OS HR 0.98 (2026). The clearest demonstration that PFS is a poor surrogate in TACE-combination trials.
- Median 14.6 vs 10 months with TACE + lenvatinib + pembrolizumab compared with TACE + placebo; about 4.6 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 34 percent lower chance of the event at any given time (hazard ratio 0.66).
- The p-value (0.0002) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- 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.
- The treated group had about 2 percent lower chance of the event at any given time (hazard ratio 0.98).
- 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.
- These results apply to the people the trial enrolled: Unresectable non-metastatic HCC: TACE + lenvatinib + pembrolizumab vs TACE + placebo. 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.
480 participants enrolled.
Numbers not yet public.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | TACE + lenvatinib + pembrolizumab | — | 14.6 months | 0.66 | 0.0002 | — |
| TACE + placebo | — | 10 months | ||||
| Overall survival (final)primary | TACE + lenvatinib + pembrolizumab | — | — | 0.98 | — | — |
| TACE + placebo | — | — |
Pages like this
not linked directly; found by shared links- TrialEMERALD-3
Shares TACE + immunotherapy/anti-VEGF, Transarterial chemoembolisation (TACE), Lenvatinib, Hepatocellular carcinoma.
- TrialEMERALD-1
Shares TACE + immunotherapy/anti-VEGF, Transarterial chemoembolisation (TACE), Hepatocellular carcinoma.
- TrialLEAP-002
Shares Lenvatinib, Hepatocellular carcinoma, Pembrolizumab.
- CompanyBoston Scientific
Shares Transarterial chemoembolisation (TACE), Hepatocellular carcinoma.
- TrialREFLECT
Shares Lenvatinib, Hepatocellular carcinoma.
- TrialLITESPARK-012
Shares Lenvatinib, Pembrolizumab.
- TermTACE (transarterial chemoembolisation)
Shares Transarterial chemoembolisation (TACE), Hepatocellular carcinoma.
- TrialKEYNOTE-775 / Study 309
Shares Lenvatinib, Pembrolizumab.