A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) plus Zanubrutinib (BGB-3111) Compared with Venetoclax plus Acalabrutinib in Patients with Previously Untreated Chronic Lymphocytic Leukemia

Trial status: Authorised • uMRD4 rate defined as the proportion of patients that achieved uMRD4 measured in both PB and BMA at the PTFU1 Visit based on next-generation sequencing (NGS [clonoSEQ]), • PFS as determined by IRC in high-risk patients that have unmutated IGHV and/or TP53 aberrations (del(17p) present and/or TP53 mutated), • OS, defined as time from the date of randomization to the date of death due to any cause, • ORR defined as the proportion of patients with a CR, CRi, nodular partial response (nPR), or partial response (PR) per the IRC assessment, • uMRD5 rate defined as the proportion of patients that achieved uMRD5 measured in both PB and BMA at the PTFU1 Visit based on NGS (clonoSEQ), • Adverse events (AEs), adverse events of clinical interest (AECIs), serious adverse events (SAEs), changes from baseline in clinical laboratory tests, physical examinations, and vital signs, • PFS determined by investigator assessment, • Overall CRR determined by IRC and by investigator assessment., • ORR determined by investigator assessment, • Duration of response (DOR; determined by both IRC and investigator assessment) defined as the time from first qualifying response (CR, CRi, nPR, or PR) until disease progression or death, • Time to next treatment (TTNT) defined as the time from randomization to the start of next treatment for CLL, • Patient-reported symptoms of global health status (GHS), role functioning, and physical functioning, symptom burden, and physical condition/fatigue measured by European Organization for Research and Treatment of Cancer quality of life questionnaire EORTC IL-409 • PFS, defined as time from the date of randomization to the date of disease progression as determined by IRC or death due to any cause, whichever occurs first.

• uMRD4 rate defined as the proportion of patients that achieved uMRD4 measured in both PB and BMA at the PTFU1 Visit based on next-generation sequencing (NGS [clonoSEQ]), • PFS as determined by IRC in high-risk patients that have unmutated IGHV and/or TP53 aberrations (del(17p) present and/or TP53 mutated), • OS, defined as time from the date of randomization to the date of death due to any cause, • ORR defined as the proportion of patients with a CR, CRi, nodular partial response (nPR), or partial response (PR) per the IRC assessment, • uMRD5 rate defined as the proportion of patients that achieved uMRD5 measured in both PB and BMA at the PTFU1 Visit based on NGS (clonoSEQ), • Adverse events (AEs), adverse events of clinical interest (AECIs), serious adverse events (SAEs), changes from baseline in clinical laboratory tests, physical examinations, and vital signs, • PFS determined by investigator assessment, • Overall CRR determined by IRC and by investigator assessment., • ORR determined by investigator assessment, • Duration of response (DOR; determined by both IRC and investigator assessment) defined as the time from first qualifying response (CR, CRi, nPR, or PR) until disease progression or death, • Time to next treatment (TTNT) defined as the time from randomization to the start of next treatment for CLL, • Patient-reported symptoms of global health status (GHS), role functioning, and physical functioning, symptom burden, and physical condition/fatigue measured by European Organization for Research and Treatment of Cancer quality of life questionnaire EORTC IL-409

Age group: 65+ years, 18-64 years Gender: Female, Male Target enrollment: 140 participants