BTK Inhibitor
Pirtobrutinib
Phase
3
Enrolling
A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Investigator’s Choice of BTK Inhibitor in Patients With Previously Treated BTK Inhibitor-Naïve Mantle Cell Lymphoma*
Related Resources:
Key Inclusion Criteria
- Confirmed mantle cell lymphoma (MCL) diagnosis that has been previously treated with at least one prior line of systemic therapy
- Measurable disease per Lugano criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Absolute neutrophil count ≥0.75 × 109/L without granulocyte-colony stimulating factor support within 7 days of screening
- Hemoglobin ≥8 g/dL and platelets ≥50 × 109/L not requiring transfusion support or growth factors within 7 days of screening
- AST and ALT ≤3.0 x upper limit of normal (ULN); total bilirubin ≤1.5 x ULN
- Creatinine clearance of ≥30 mL/min according to Cockcroft-Gault formula
Key Exclusion Criteria
- Prior treatment with an approved or investigational BTK inhibitor
- History of bleeding diathesis
- History of stroke or intracranial hemorrhage within 6 months of randomization
- History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor-modified T-cell (CAR-T) therapy within 60 days of randomization
- Clinically significant cardiovascular disease
- Prolonged QT interval corrected using Fridericia's formula (QTcF) >470 ms on two out of three consecutive ECGs, and mean QTcF >470 ms on all three ECGs
- Known HIV infection or active HBV, HCV, or CMV infections
- Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption
- Ongoing chronic treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers, which cannot be stopped within 3-5 half-lives of the CYP3A inhibitor therapy prior to start of study treatment
- Patients requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist
- Vaccination with live vaccine within 28 days prior to randomization
*
This clinical trial is being conducted globally.
†
Pirtobrutinib is administered 200 mg PO QD until therapy discontinuation.
‡
Ibrutinib is administered 560 mg PO QD.
§
Acalabrutinib is administered 100 mg PO BID.
‖
Zanubrutinib is administered 160 mg PO BID or 320 mg PO QD.
