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NCT04680052 (Tafasitamab Rituximab Lenalidomide Placebo in Relapsed/​Refractory Follicular Lymphoma or Marginal Zone…): BVCT ex-ante prediction vs. reported outcome

On 30 Nov 2023, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 15 Aug 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT04680052
Acronym
InMIND
Drug Name
Tafasitamab Rituximab Lenalidomide Placebo
Drug MoA
anti-CD19 Fc-enhanced mAb
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Relapsed/​Refractory (R/​R) Follicular Lymphoma or Marginal Zone Lymphoma
Human Patients
654
Sponsor
Incyte Corporation
Phase
Phase 3

Prediction of , index 1358

Prospective Prediction
Prediction Index
1358
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
259 days in advance
Readout Data Interpretation
superior to the SoC (Lenalidomide + Rituximab) for both PFS (primary endpoint met) and CR (secondary endpoint met).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma
Phase
Phase 3
Status
Active not recruiting
Enrollment
654
Lead sponsor
Incyte Corporation
Conditions
Follicular Lymphoma; Marginal Zone Lymphoma
Interventions
DRUG: tafasitamab; DRUG: rituximab; DRUG: lenalidomide; DRUG: placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2021-04-15
Primary completion
2024-02-23
Completion
2028-08-09
Results first posted
2025-04-04
Primary outcomes
  • FL Population: Progression-free Survival (PFS) by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented Disease Progression (PD), or Death From Any Cause, Whichever Occurred First (up to approximately 34 months)
  • FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First (up to 2 years)

NCT04680052 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials