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NCT04975308 (Imlunestrant in 2L HR+/HER2- Metastatic Breast Cancer): BVCT ex-ante prediction vs. reported outcome

On 17 Jul 2024, BioinvestGPT's BVCT predicted technical partial success and commercial partial success for this trial. The 11 Dec 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: partially statistically insignificant (monotherapy in PFS) and partially statistically significant (combotherapy in PFS) and commercially TBD (wait for OS data).

Clinical Trial

NCTID
NCT04975308
Acronym
EMBER-3
Drug Name
Imlunestrant
Drug MoA
oral next-gen SERD
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Neoplasms
Indication
2L HR+/HER2- Metastatic Breast Cancer
Human Patients
866
Sponsor
Eli Lilly and Company
Phase
Phase 3

Prediction of , index 1686

Prospective Prediction
Prediction Index
1686
Prediction Date
Commercial Prediction
partial SUCCESS (commercially maybe sufficient clinical benefit in combination with abemaciclib as all-oral regimens; despite non-superior efficacy in PFS/OS compared with fulvestrant/exemestane + abemaciclib)
Technical Prediction
partial SUCCESS (statistically significant clinical benefit in PFS/OS non-superior non-inferior to fulvestrant/exemestane)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
147 days in advance
Readout Data Interpretation
imlunestrant + SoC failed to achieve statistical significance in PFS compared with SoC alone in all patients (5.6 months vs 5.5 months; p=0.12); imlunestrant + abemaciclib achieved statistical significance in PFS compared with imlunestrant alone in all patients (9.4 months vs 5.5 months p<0.001); OS data immature
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
partially statistically insignificant (monotherapy in PFS) and partially statistically significant (combotherapy in PFS) and commercially TBD (wait for OS data)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
EMBER-3: A Phase 3, Randomized, Open-Label Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With Endocrine Therapy
Phase
Phase 3
Status
Active not recruiting
Enrollment
874
Lead sponsor
Eli Lilly and Company
Conditions
Breast Neoplasms; Neoplasm Metastasis
Interventions
DRUG: Imlunestrant; DRUG: Exemestane; DRUG: Fulvestrant; DRUG: Abemaciclib
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2021-10-04
Primary completion
2024-06-24
Completion
2027-08
Results first posted
2025-07-11
Primary outcomes
  • Investigator-assessed Progression Free Survival (PFS) (Between Arm A and Arm B) (Randomization to the date of first documented progression of disease or death from any cause (up to 28 months))
  • Investigator-assessed PFS (Between Arm C and Arm A) (Randomization to the date of first documented progression of disease or death from any cause (up to 26 months))
  • Investigator-assessed PFS in the Estrogen Receptor 1 (ESR1)-Mutation Detected Population (Between Arm A and Arm B) (Randomization to the date of first documented progression of disease or death from any cause (up to 28 months))

NCT04975308 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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