Figure 1.
Figure 1. Dosing schedule. Schedule A, Venetoclax followed by obinutuzumab. Schedule B, Obinutuzumab followed by venetoclax. For both the R/R and 1L populations, schedule A was examined prior to schedule B. Data from schedule A provided safety guidance for subsequent dose finding for patients in schedule B after a data review by an internal monitoring safety team and a scientific overview committee. Venetoclax ramp-up: 3 weeks for the 100-mg cohort, 4 weeks for the 200-mg cohort, and 5 weeks for the 400-mg cohort; each cohort dose was continued for a total of 12 months with potential for extension if BM MRD+ or PR (1L) or until disease progression (R/R); venetoclax plus obinutuzumab (6 cycles), then venetoclax monotherapy. Cohort 4 (600 mg) was planned but not explored. Venetoclax ramp-up and maximum cohort dose are indicated by the blue arrows. Obinutuzumab dosing schedule: C1D1, 100 mg; C1D2, 900 mg; C1D8 and 15, 1000 mg; C2-6D1, 1000 mg. C, cycle; D, day; G, GA101/obinutuzumab; PR, partial response; RD1, ramp-up day 1; W, week.

Dosing schedule. Schedule A, Venetoclax followed by obinutuzumab. Schedule B, Obinutuzumab followed by venetoclax. For both the R/R and 1L populations, schedule A was examined prior to schedule B. Data from schedule A provided safety guidance for subsequent dose finding for patients in schedule B after a data review by an internal monitoring safety team and a scientific overview committee. Venetoclax ramp-up: 3 weeks for the 100-mg cohort, 4 weeks for the 200-mg cohort, and 5 weeks for the 400-mg cohort; each cohort dose was continued for a total of 12 months with potential for extension if BM MRD+ or PR (1L) or until disease progression (R/R); venetoclax plus obinutuzumab (6 cycles), then venetoclax monotherapy. Cohort 4 (600 mg) was planned but not explored. Venetoclax ramp-up and maximum cohort dose are indicated by the blue arrows. Obinutuzumab dosing schedule: C1D1, 100 mg; C1D2, 900 mg; C1D8 and 15, 1000 mg; C2-6D1, 1000 mg. C, cycle; D, day; G, GA101/obinutuzumab; PR, partial response; RD1, ramp-up day 1; W, week.

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