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NCT05254743 (Pirtobrutinib in Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma): BVCT ex-ante prediction vs. reported outcome

On 30 Mar 2025, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 7 Dec 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (for non-inferiority only) and commercially TBD.

Clinical Trial

NCTID
NCT05254743
Acronym
BRUIN-CLL-314
Drug Name
Pirtobrutinib
Drug MoA
non-covalent BTK inhibitor
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Neoplasms
Indication
Chronic Lymphocytic Leukemia (CLL) Small Lymphocytic Lymphoma (SLL)
Human Patients
737
Sponsor
Eli Lilly
Phase
Phase 3

Prediction of , index 1956

Prospective Prediction
Prediction Index
1956
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in OS non-superior to ibrutinib)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit in ORR/PFS at most slightly superior to ibrutinib)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
252 days in advance
Readout Data Interpretation
pirtobrutinib met primary endpoint of ORR non-inferiority vs ibrutinib (87.0% vs 78.5%; p<0.0001); PFS or OS data immature.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (for non-inferiority only) and commercially TBD
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-314)
Phase
Phase 3
Status
Recruiting
Enrollment
737
Lead sponsor
Loxo Oncology, Inc.
Conditions
Chronic Lymphocytic Leukemia; Leukemia, Lymphocytic; Leukemia, B-cell; Small Lymphocytic Lymphoma
Interventions
DRUG: Pirtobrutinib; DRUG: Ibrutinib
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2022-07-22
Primary completion
2027-10
Completion
2028-01
Primary outcomes
  • Percentage of Participants Achieving Complete Response (CR), Complete Remission with Incomplete Hematologic Recovery (Cri), Nodular Partial Remission (nPR) or Partial Response (PR): Overall Response Rate (ORR) Part 1 (Baseline to best overall response the best response recorded from Cycle 1 Day 1 until data cutoff date, PD, or start of new anticancer treatment, whichever is the earliest] (approximately 3 years and 5 months))
  • Percentage of Participants Achieving Complete Response (CR), Complete Remission with Incomplete Hematologic Recovery (CRi), Nodular Partial Remission (nPR) or Partial Response (PR): Overall Response Rate (ORR) Part 2 (Baseline to best overall response the best response recorded from Cycle 1 Day 1 until data cutoff date, PD, or start of new anticancer treatment, whichever is the earliest (Approximately 2 years and 3 months))

NCT05254743 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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