trialsTrialNegative

AMPLIFY-7P

The randomised test of an off-the-shelf KRAS vaccine after pancreatic surgery. It missed its primary goal in June 2026.

Did not meet the pre-specified primary DFS endpoint in the intent-to-treat population; post-hoc landmark analyses suggested ~14% absolute DFS benefit during active dosing. Company is exploring R0-resected subgroups for phase 3. A cautionary data point for shared-antigen vaccines versus personalised approaches.

Setting

Adjuvant mKRAS PDAC after surgery and chemotherapy: ELI-002 7P vs observation

Phase

Phase 1/2

Sponsor

Elicio Therapeutics

Registry

Headline result

Primary DFS endpoint not met.

Started

2023-04-14

Reported

2026

Enrolled

158 enrolled

Replication

Randomised phase 2 missed its primary ITT endpoint (June 2026); the post hoc R0 subgroup signal is unreplicated and the sponsor plans a refined phase 3.

Outcomes

In plain words

What these results mean for people, not percentages

158 enrolled

Disease-free survival (ITT)primarysurrogate endpoint

Numbers are not recorded here for this endpoint. ELI-002 7P: Primary endpoint not met (sponsor release, 15 June 2026); ITT hazard ratio and medians not disclosed.; Observation.

Disease-free survival at 3 months (landmark)surrogate endpoint

90.3 vs 76.6 out of 100 alive without the cancer coming back at 3 months with ELI-002 7P compared with Observation; 13.7 more per 100.
Roughly one extra person helped for every 7 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.

The p-value (0.022) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.

Disease-free survival, R0-resected subgroup (post hoc)surrogate endpoint

Median 23.8 vs 12.8 months with ELI-002 7P compared with Observation; about 11 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 35 percent lower chance of the event at any given time (hazard ratio 0.65).

The p-value (0.048) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
Post hoc analysis of 121 R0-resected patients; hypothesis-generating only.

Caveats

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.
These results apply to the people the trial enrolled: Adjuvant mKRAS PDAC after surgery and chemotherapy: ELI-002 7P vs observation. 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.

158 enrolled.

Disease-free survival (ITT)primary

Primary endpoint not met (sponsor release, 15 June 2026); ITT hazard ratio and medians not disclosed.

Disease-free survival at 3 months (landmark)

· p = 0.022

ELI-002 7P90.3 of 100

Observation76.6 of 100

Download

Disease-free survival, R0-resected subgroup (post hoc)

HR 0.65 · p = 0.048

Download

Post hoc analysis of 121 R0-resected patients; hypothesis-generating only.

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Disease-free survival (ITT)primary	ELI-002 7P	-	Primary endpoint not met (sponsor release, 15 June 2026); ITT hazard ratio and medians not disclosed.	-	-	link
Disease-free survival (ITT)primary	Observation	-	-	-	-	link
Disease-free survival at 3 months (landmark)	ELI-002 7P	-	90.3%	-	0.022	link
Disease-free survival at 3 months (landmark)	Observation	-	76.6%	-	0.022	link
Disease-free survival, R0-resected subgroup (post hoc)	ELI-002 7P	-	23.8 months	0.65	0.048	link
Disease-free survival, R0-resected subgroup (post hoc)	Observation	-	12.8 months	0.65	0.048	link

Replication

Randomised phase 2 missed its primary ITT endpoint (June 2026); the post hoc R0 subgroup signal is unreplicated and the sponsor plans a refined phase 3.

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