ith 17p deletion who had received at least one prior therapy. In the study, 17p deletion was confirmed in peripheral blood specimens from patients using Vysis CLL FISH Probe Kit, which is FDA approved for selection of patients for VENCLEXTA treatment. Patients received VENCLEXTA via a weekly ramp-up schedule starting at 20 mg and ramping to 50 mg, 100 mg, 200 mg and finally 400 mg once daily. Patients continued to receive 400 mg of VENCLEXTA orally once daily until disease progression or unacceptable toxicity.
The efficacy of VENCLEXTA was eva luated by overall response rate (ORR) as assessed by an Independent Review Committee (IRC) using the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines (2008).
Table 9 summarizes the baseline demographic and disease characteristics of the study population.
Table 9. Baseline Patient Characteristics Characteristics N = 106
Age, years; median (range) 67 (37-83)
White; % 97.1
Male; % 65.1
ECOG performance status; %
0
1
2
39.6
51.9
8.5
Tumor burden; %
Absolute lymphocyte count ≥25 x 109/L
One or more nodes ≥5 cm
50.0
52.8
Number of prior therapies; median (range) 2.5 (1-10)
Time since diagnosis, months; median (range)a 79.4 (1.2-385.6)
aN=105.
The median time on treatment at the time of eva luation was 12.1 months (range: 0 to 21.5 months). Efficacy results are shown in Table 10.
Table 10. Efficacy Results for Patients with Previously Treated CLL with 17p Deletion by IRC VENCLEXTA
N=106
ORR, n (%)
(95% CI) 85 (80.2)
(71.3, 87.3)
CR + CRi, n (%)
CR, n (%)
CRi, n (%) 8 (7.5)
6 (5.7)
2 (1.9)
nPR, n (%) 3 (2.8)
PR, n (%) 74 (69.8)
CI = confidence interval; CR = complete remission; CRi = complete remission with incomplete marrow recovery; IRC = independent review committee; nPR = nodular partial remission; ORR = overall response rate (CR + CRi + nPR + PR); PR = partial remission.
The median time to first response was 0.8 months (range: 0.1 to 8.1 months). Median duration of response (DOR) has not been reached with approximately 12 months median follow-up. The DOR ranged from 2.9 to 19.0+ months.
Minimal residual disease (MRD) was eva luated in peripheral blood and bone marrow for patients who achieved CR or CRi, following treatment with VENCLEXTA. Three percent (3/106) were MRD negative in the peripheral blood and bone marrow (less than one CLL cell per 104 leukocytes).
16 HOW SUPPLIED/STORAGE AND HANDLING
VENCLEXTA is dispensed as follows:
Packaging Presentation Number of Tablets National Drug Code (NDC)
Starting Pack Each pack contains four weekly wallet blister packs:
Week 1 (14 x 10 mg tablets)
Week 2 (7 x 50 mg tablets)
Week 3 (7 x 100 mg tablets)
Week 4 (14 x 100 mg tablets)
0074-0579-28
10 mg Wallet 14 x 10 mg tablets 0074-0561-14
50 mg Wallet 7 x 50 mg tablets 0074-0566-07
10 mg Unit Dose 2 x 10 mg tablets 0074-0561-11
50 mg Unit Dose 1 x 50 mg tablet 0074-0566-11
100 mg Unit Dose 1 x 100 mg ta |
