trialsTrialNegative

LEAP-002

Adding pembrolizumab to lenvatinib did not significantly extend life, a reminder that not every immunotherapy plus anti-angiogenic pairing works.

OS 21.2 vs 19.0 months (HR 0.84) missed the pre-specified boundary; PFS also not significant. The lenvatinib control arm performed unusually well.

Setting

First-line unresectable HCC: lenvatinib + pembrolizumab vs lenvatinib

Phase

Phase 3

Sponsor

Merck / Eisai

Registry

NCT03713593

Headline result

OS HR 0.84, not significant.

Reported

2022

Enrolled

794

Outcomes

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In plain words

What these results mean for people, not percentages

794 people took part

Overall survivalprimarysurvival endpoint

Median 21.2 vs 19 months with Lenvatinib + pembrolizumab compared with Lenvatinib; about 2.2 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 16 percent lower chance of the event at any given time (hazard ratio 0.84, likely range 0.71 to 1).

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: First-line unresectable HCC: lenvatinib + pembrolizumab vs lenvatinib. 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.

794 participants enrolled.

Overall survivalprimary

HR 0.84 (0.71–1)

Lenvatinib + pembrolizumab

21.2 mo

Lenvatinib

19 mo

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Overall survivalprimary	Lenvatinib + pembrolizumab	395	21.2 months	0.84 (0.71–1)	—	—
Overall survivalprimary	Lenvatinib	399	19 months	0.84 (0.71–1)	—	—