Oncology Pipeline

For more than 50 years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. In 2019 Lilly created Loxo Oncology at Lilly, with the goal of rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating new medicines that work in early clinical development and will matter to patients.

Phase 3

BRUIN CLL-322; NCT04965493

CLL/SLL

BTK Inhibitor


A Phase 3 Open-Label, Randomized Study of Fixed Duration Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab Versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma*

NCT04965493
Key Inclusion Criteria
  • Confirmed diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) requiring therapy as defined by International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria
  • Previously treated with at least one line of therapy that may include a covalent BTK inhibitor
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Platelets ≥50 x 109/L, hemoglobin ≥8 g/dL, and absolute neutrophil count ≥1.0 x 109/L
  • Adequate organ function
  • Estimated creatinine clearance ≥30 mL/min
Key Exclusion Criteria
  • Known or suspected Richter’s transformation at any time preceding enrollment
  • Uncontrolled immune thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia (AIHA)
  • Central nervous system (CNS) involvement
  • Significant cardiovascular disease
  • History of allogeneic stem cell transplantation (SCT) or chimeric antigen receptor-modified T-cell (CAR-T) therapy within the past 60 days
  • Active hepatitis B or C
  • Known active cytomegalovirus (CMV) infection
  • Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
  • Known HIV infection, regardless of CD4 count
  • Previously treated with venetoclax
  • Prior exposure to a noncovalent (reversible) BTK inhibitor
  • Patients requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist
  • Current treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers and/or strong P-gp inhibitors
  • Vaccination with a live vaccine within 28 days prior to randomization
  • Patients with the following hypersensitivity:
    • Known hypersensitivity to any component or excipient of pirtobrutinib and venetoclax
    • Prior significant hypersensitivity to rituximab
    • Known allergy to allopurinol and inability to take uric acid lowering agents
*
This clinical trial is being conducted in the United States.
Pirtobrutinib is administered PO QD.
Venetoclax is administered PO QD.
§
Rituximab is administered intravenously.
Contact the Loxo Oncology at Lilly Clinical Trial Team

Visit www.clinicaltrials.gov for more information on this trial.

The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.