Table 1.

Patient demographics and baseline clinical characteristics

Subgroups of interest
All patientsdel(17p) CLLPrior BCRi
N = 350n = 211*n = 148*
Male, n (%)238 (68)137 (65)102 (69)
White, n (%)326 (94)199 (95)136 (92)
Age, median (range), years66 (28–85)66 (29–85)66 (28–85)
CLL/SLL, n (%)342 (98)/8 (2)a211 (100)146 (98)/2 (1)
TP53 mutation, n/N (%)141/297 (48)124/178 (70)46/140 (33)
Unmutated IGHV, n/N (%)137/181 (76)80/102 (78)77/99 (78)
Prior no. of therapies,b median (range)3 (1–15)3 (1–15)4 (1–15)
Prior therapies, n (%)
 Fludarabine229 (65)136 (65)87 (59)
 Bendamustine149 (43)87 (41)63 (43)
 Alkylating agents247 (71)153 (73)94 (64)
Medical history of cytopenias (within 6 months of first venetoclax dose), n (%)
 Neutropenia52 (15)49 (23)8 (5)
 Thrombocytopenia106 (30)59 (28)71 (48)
 Anemia150 (43)74 (35)82 (55)
G-CSF support at study entry46 (13)31 (15)17 (12)
ECOG performance status, n/N (%)
 0140 (40)85 (40)49 (33)
 1187 (54)111 (53)87 (59)
 220 (6)15 (7)11 (8)
 Missing301
Bulky nodes, n (%)
 One or more nodes ≥5 cm172 (49)103 (49)64 (43)
 One or more nodes ≥10 cm48 (14)26 (12)17 (12)
ALC ≥25×109/L, n (%)126 (39)93 (44)43 (30)
CrCl ≥60 mL/minute274 (78)160 (76)117 (79)
TLS risk category,c n/N (%)
 Low61/166 (37)
 Medium59/166 (36)NANA
 High46/166 (28)
  • Abbreviations: ALC, absolute lymphocyte count; BCRi, B-cell receptor pathway inhibitors (ibrutinib, idelalisib, or investigational compounds); CrCl, creatinine clearance; ECOG, Eastern Cooperative Oncology Group performance score; G-CSF, granulocyte-colony stimulating factor; NA, data not evaluated for subgroups; SLL, small lymphocytic lymphoma; TLS, tumor lysis syndrome.

  • *Subgroups include patients across all three clinical studies. The 211 patients with del(17p) CLL and 148 patients who received prior BCRi are not mutually exclusive and do not add up to the 350 patients included in the overall integrated dataset.

  • aEight patients with SLL were included in the M12-175 study.

  • bDoes not include 5 patients who were treatment naïve and received venetoclax in the M13-982 study.

  • cA total of 115 patients were included in the TLS analysis set and included only those patients who received venetoclax per the 5-week dose ramp-up schedule with current protocol TLS prophylaxis and monitoring measures. Risk categories were defined as: Low, all lymph nodes ≤5 cm and ALC <25×109/L; medium, any lymph node ≥5 cm to <10 cm or ALC ≥25×109/L; and high, any lymph node ≥10 cm or lymph node ≥5 cm and ALC ≥25 × 109/L.