A Study to Evaluate the Safety and Efficacy of Tacabrutideg (BGB-16673) Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Overall Survival (OS)

OS is defined as the time from the date of randomization to the date of death due to any cause.

Time frame: Up to approximately 3 years

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.

Time frame: Up to approximately 3 years

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.

Time frame: Up to approximately 3 years

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.

Time frame: Up to approximately 3 years

Duration of Response (DOR) per IRC and INV

DOR is defined as the time from initial response to disease progression or death, whichever occurs first.

Time frame: Up to approximately 3 years

Time to Next Anti-CLL/SLL Treatment (TTNT)

TTNT is defined as the time from the date of randomization to the date of next anti-CLL/SLL treatment.

Time frame: Up to approximately 3 years

Number of Participants with Adverse Events (AEs)

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory abnormalities.

Time frame: Up to approximately 3 years

Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire EORTC IL409

EORTC IL409 consists of a set of 19 questions derived from the EORTC quality of life questionnaire core 30 (QLQ-C30) and its CLL module CLL17. The EORTC IL409 includes questions on global health status (GHS)/quality of life, physical functioning, role functioning, physical condition/fatigue, and symptom burden.Higher scores in GHS and functional scales and lower scores in symptom scales indicate better health-related quality of life.

Time frame: Baseline and up to approximately 3 years