BTK Inhibitor
Pirtobrutinib
Phase
3
Enrolling
A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma*
Related Resources:
Key Inclusion Criteria
- Diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) requiring therapy as defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Platelets ≥50 x 10⁹/L, hemoglobin ≥8 g/dL, and absolute neutrophil count ≥0.75 x 10⁹/L
- Adequate organ function
- Kidney function: Estimated creatinine clearance ≥30 mL/min
Key Exclusion Criteria
- Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin's lymphoma at any time preceding enrollment
- Known or suspected central nervous system (CNS) involvement
- Significant history of renal, neurologic, psychiatric, endocrine, metabolic, or immunologic disease
- Active uncontrolled autoimmune cytopenia (eg, autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP])
- Significant cardiovascular disease
- Active hepatitis B or C
- Active cytomegalovirus (CMV) infection
- Active uncontrolled systemic bacterial, viral, or fungal infection
- Known HIV infection, regardless of cluster of differentiation 4 (CD4) count
- Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption
- Ongoing inflammatory bowel disease
- Prior exposure to BTK inhibitor (covalent or non-covalent)
- Concurrent use of investigational agent or anticancer therapy, except hormonal therapy
- Patients requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist
- Use of ≥20 mg prednisone daily or equivalent dose of steroid with the first dose of study treatment
- Vaccination with a live vaccine within 28 days prior to randomization
- Chronic therapy with a strong cytochrome P450 3A (CYP3A) inhibitor (except posaconazole and voriconazole), which cannot be stopped within 3-5 half-lives of the CYP3A inhibitor therapy prior to start of study drug
- Known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or ibrutinib
*
This clinical trial is being conducted globally.
†
Pirtobrutinib is administered PO.
‡
Ibrutinib is administered PO.
