An Open Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of the BCL2 Inhibitor Sonrotoclax (BGB 11417) as Monotherapy and in Combination with Zanubrutinib (BGB-3111) in Patients With Waldenström Macroglobulinemia

previously untreated WM, Relapsed/Refractory Waldenström’s Macroglobulinemia

Major response rate (MRR, defined as the proportion of patients achieving partial response [PR] or better per the 11th International Workshop on Waldenström Macroglobulinemia (IWWM) (hereafter as IWWM-11 WM response criteria) as assessed by the Independent Review Committee (Cohort 1)

MRR as assessed by the IRC in Cohorts 2 and 3 and by the investigator in Cohorts 1 to 4, Duration of major response (DoMR) as assessed by the IRC in Cohort 1 to 3 and by the investigator in Cohorts 1 to 4, Complete response (CR) + very good partial response (VGPR) rate as assessed by the IRC in Cohorts 1 to 3 and by the investigator in Cohorts 1 to 4, Overall response rate (ORR, defined as the proportion of patients achieving minor response [MR] or better) as assessed by the IRC in Cohorts 1 to 3 and by the investigator in Cohorts 1 to 4, Progression free survival (PFS) as assessed by the IRC and investigator in Cohorts 1 to 3, Time to major response as assessed by the IRC in Cohorts 1 to 3 and by the investigator in Cohorts 1 to 4, Overall survival (OS) in Cohorts 1 to 3, The frequency and severity of adverse events, serious adverse events, and laboratory abnormalities according to National Cancer Institute Common Terminology for Adverse Event (NCI CTCAE v5.0), Health-related quality of life (HRQoL) based on patient reported outcomes (PRO) using National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index 18 Item (NFLymSI-18) Version 4, Duration of response (DOR) as assessed by the IRC in Cohorts 1 to 3 and by the investigator in Cohorts 1 to 4, Time to next treatment in Cohort 4

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