OnCo
trialsTrialMixed

VERITAC-2

The trial that got the first PROTAC approved, with benefit only in tumours with ESR1 mutations.

PFS 5.0 vs 2.1 months (HR 0.57) in ESR1-mutant; no benefit in overall population. Approved Q2 2026 for ESR1-mutant disease.

Setting
ER+/HER2- advanced breast cancer after CDK4/6 and endocrine therapy: vepdegestrant vs fulvestrant
Phase
Phase 3
Sponsor
Arvinas / Pfizer
Registry
Headline result
PFS HR 0.57 in ESR1-mutant; ITT not significant.
Reported
2025
Enrolled
624
Replication
Mirrors EMERALD (elacestrant): benefit confined to ESR1-mutant tumours. Two oral ER-degrading agents now show the same pattern.

Outcomes

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In plain words
What these results mean for people, not percentages
624 people took part
Progression-free survival, ESR1-mutant (BICR)primarysurrogate endpoint
  • Median 5 vs 2.1 months with Vepdegestrant compared with Fulvestrant; about 2.9 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 43 percent lower chance of the event at any given time (hazard ratio 0.57, likely range 0.42 to 0.77).
Progression-free survival, ITTprimarysurrogate endpoint
  • Median 3.7 vs 3.6 months with Vepdegestrant compared with Fulvestrant; about 0.1 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 17 percent lower chance of the event at any given time (hazard ratio 0.83, likely range 0.68 to 1.02).
  • The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
  • Not significant.
Be careful
  • 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: ER+/HER2- advanced breast cancer after CDK4/6 and endocrine therapy: vepdegestrant vs fulvestrant. People in a different situation may not see the same effect.
  • The trial selected people by a biomarker (HER2); the result should not be assumed for people whose cancer does not have it.

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.

624 participants enrolled.

Progression-free survival, ESR1-mutant (BICR)primary
HR 0.57 (0.42–0.77) · p <0.001
Vepdegestrant
5 mo
Fulvestrant
2.1 mo
Source
Progression-free survival, ITTprimary
HR 0.83 (0.68–1.02)
Vepdegestrant
3.7 mo
Fulvestrant
3.6 mo

Not significant

Source
EndpointArmnValueHR (95% CI)pSource
Progression-free survival, ESR1-mutant (BICR)primaryVepdegestrant1365 months0.57 (0.42–0.77)<0.001link
Fulvestrant1342.1 months
Progression-free survival, ITTprimaryVepdegestrant3133.7 months0.83 (0.68–1.02)link
Fulvestrant3113.6 months
Replication
Mirrors EMERALD (elacestrant): benefit confined to ESR1-mutant tumours. Two oral ER-degrading agents now show the same pattern.

Key papers

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Connected

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