Supplementary Data from Phase Ib Study of Tirabrutinib in Combination with Idelalisib or Entospletinib in Previously Treated Chronic Lymphocytic Leukemia
Year: 2023
Type: supplementary-materials
Abstract: Supplemental Table 1 summarizes study inclusion and exclusion criteria. Supplemental Table 2 shows the doses and dose-escalation strategy used in this study. Supplemental Table 3 defines the dose-limiting toxicities that guided dose escalation. Supplemental Table 4 lists the number of patients by disease in the dose expansion phase. Supplemental Table 5 summarizes study drug exposure. Supplemental Table 6 lists TEAEs and laboratory abnormalities of interest that occurred during the study. Supplemental Table 7 shows responders and nonresponders according to biomarker risk groups. Supplemental Table 8 shows best overall response and gene aberration status as measured by FISH and NGS. Supplemental Table 9 provides tirabrutinib peak plasma concentrations. Supplemental Table 10 summarizes tirabrutinib, idelalisib, and entospletinib plasma exposure (AUC) and maximum plasma concentrations (Cmax). Supplemental Table 11 shows patients with free BTK below the lower limit of quantitation. Supplemental Figure 1 graphically illustrates the design of the study. Supplemental Figure 2 illustrates the disposition of patients over the course of the study. Supplemental Figure 3 shows line graphs illustrating tirabrutinib plasma concentrations over time. Supplemental Figure 4 shows box plots representing BTK levels at baseline and trough tirabrutinib concentrations.
Institutions: Oregon Health & Science University, OHSU Knight Cancer Institute, City Of Hope National Medical Center, Centre Hospitalier Universitaire de Lille, University of Leicester, University of Leeds, University of Plymouth, Goshen Health, Hospices Civils de Lyon, Hôpital Lyon Sud, Gilead Sciences (United States)
Language: English
Subfield: Genetics
Field: Medicine
Domain: Health Sciences
Open Access status: gold
OpenAlex ID: W4361815591