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  | ENROLLING  | Investigational Drug

BRUIN CLL-313; NCT05023980

CLL/SLL

BTK Inhibitor


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*

NCT05023980
Key Inclusion Criteria
  • Diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) requiring therapy as defined by International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Platelets ≥75 x 109/L (≥50 × 109/L for patients with evidence of bone marrow infiltrate), hemoglobin ≥8 g/dL, and absolute neutrophil count ≥0.75 x 109/L
  • Adequate organ function
  • Kidney function: Estimated creatinine clearance ≥40 mL/min
Key Exclusion Criteria
  • Known or suspected Richter’s transformation at any time preceding enrollment
  • Prior systemic therapy for CLL/SLL
  • Presence of 17p deletion
  • Central nervous system (CNS) involvement
  • 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, fungal, or parasitic infection
  • Known HIV infection, regardless of cluster of differentiation 4 (CD4) count
  • Concurrent use of investigational agent or anticancer therapy except hormonal therapy
  • Patients requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist
  • Vaccination with a live vaccine within 28 days prior to randomization
  • Patients with the following hypersensitivity:
    • Known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or bendamustine
    • Prior significant hypersensitivity to rituximab
*
This clinical trial is being conducted globally.
Pirtobrutinib is administered PO.
Bendamustine is administered intravenously (IV).
§
Rituximab is administered IV.
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.