Rocbrutinib vs Pirtobrutinib in Covalent BTK Inhibitor Pretreated Relapsed or Refractory CLL/SLL

Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are types of cancer that affect white blood cells, causing an accumulation of abnormal cells. While current treatments have improved outcomes, some patients experience disease progression or intolerance to therapy, leading to limited options and potentially poor results. This study focuses on adults with relapsed or refractory CLL/SLL who have previously received a specific type of treatment called a covalent BTK inhibitor. The aim is to find effective and well-tolerated therapies for these patients. Rocbrutinib (LP-168) is an experimental drug under investigation, while Pirtobrutinib is an approved drug for this condition. This phase 3 study compares the safety and effectiveness of these two drugs in treating CLL/SLL. In this global study, approximately 306 participants will be randomly assigned to receive either Rocbrutinib or Pirtobrutinib. Eligible participants are adults with confirmed CLL or SLL who require therapy and have previously received a covalent BTK inhibitor. Participants will take their assigned drug orally once daily in 28-day cycles until disease progression, unacceptable side effects, withdrawal of consent, or other study-defined criteria. The primary goal is to measure progression-free survival, or the time during and after treatment that a patient lives with the disease but it does not get worse. Secondary goals include assessing overall survival, response rate, duration of response, and safety of Rocbrutinib compared to Pirtobrutinib.