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NCT05023980 (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 8 Sep 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (superior PFS compared with bendamustine plus rituximab) and commercially TBD.

Clinical Trial

NCTID
NCT05023980
Acronym
BRUIN CLL-313
Drug Name
Pirtobrutinib (LOXO-305)
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
309
Sponsor
Eli Lilly and Company
Phase
Phase 3

Prediction of , index 1955

Prospective Prediction
Prediction Index
1955
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in OS non-superior to rituximab + bendamustine; slightly inferior to zanubrutinib/venetoclax + obinutuzumab)
Technical Prediction
partial SUCCESS (statistically significant clinical benefit in ORR/PFS slightly superior to rituximab + bendamustine; slightly inferior to zanubrutinib/venetoclax + obinutuzumab)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
162 days in advance
Readout Data Interpretation
pirtobrutinib achieved superiority in PFS compared with bendamustine plus rituximab; wait for detailed PFS data for comparison with zanubrutinib/venetoclax + obinutuzumab; wait for OS data
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (superior PFS compared with bendamustine plus rituximab) and commercially TBD
Prediction Classification
True Positive (TP)

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 Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Phase
Phase 3
Status
Active not recruiting
Enrollment
309
Lead sponsor
Loxo Oncology, Inc.
Conditions
Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
Interventions
DRUG: Pirtobrutinib; DRUG: Bendamustine; DRUG: Rituximab
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2021-09-23
Primary completion
2025-07-11
Completion
2027-10
Primary outcomes
  • To evaluate progression-free survival (PFS) of pirtobrutinib (Arm A) compared to bendamustine and rituximab (Arm B) (Up to approximately 5 years)

NCT05023980 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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