The purpose of this study is to evaluate the efficacy and safety of tacabrutideg alone compared with pirtobrutinib in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi).
Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 iwCLL criteria
Previously received treatment for CLL/SLL with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Patients should have disease relapsed after or refractory to at least 1 line of therapy including a cBTKi.
Participants with SLL must have measurable disease by computed tomography/magnetic resonance imaging, defined as ≥ 1 lymph node > 1.5 cm in longest diameter and measurable in 2 perpendicular diameters.
Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation.
History of known bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug
Prior exposure to any Bruton tyrosine kinase (BTK) protein degraders or noncovalent Bruton tyrosine kinase inhibitor (ncBTKi).
Parallel
Tacabrutideg
DrugTacabrutideg will be administered orally
Pirtobrutinib
DrugPirtobrutinib will be administered orally
Progression-Free Survival (PFS) per Independent Review Committee (IRC)
PFS is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by IRC using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with chronic lymphocytic leukemia (CLL) and Lugano classification for participants with small lymphocytic lymphoma (SLL).
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause.
PFS per Investigator (INV)
PFS per INV is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by investigator using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with CLL and Lugano classification for participants with SLL.
Overall Response Rate (ORR) per IRC and INV
ORR is defined as the percentage of participants with a best overall response of complete response, complete response with incomplete bone marrow recovery, nodular partial remission, or partial response, as assessed by the investigator and IRC using modified 2018 iwCLL criteria for patients with CLL and Lugano classification for patients with SLL.
Rate of Partial Response with Lymphocytosis (PR-L) or Higher per IRC and INV
The rate of PR-L or higher is defined as the percentage of participants with a best overall response of complete response, complete response with incomplete bone marrow recovery, nodular partial remission, partial response, or PR-L.
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