Table 2

Three-year safety of ibrutinib in patients with CLL and SLL

TN ≥65 years (n = 31)R/R (n = 101)All patients (N = 132)
Median treatment duration, months (range)30 (0.3-44)23 (0.3-45)25 (0.3-45)
Treatment duration
 ≤1 years5 (16)24 (24)29 (22)
 >1-2 years1 (3)31 (31)32 (24)
 >2-3 years15 (48)33 (33)48 (36)
 >3 years10 (32)13 (13)23 (17)
Grade ≥3 AEs
 Hematologic4 (13)32 (32)36 (27)
 Nonhematologic18 (58)83 (82)101 (77)
 Infections4 (13)52 (51)56 (42)
Dose reductions
 ≤1 years1/31 (3)10/101 (10)11/132 (8)
 >1-2 years1/26 (4)0/77 (0)1/103 (1)
 >2-3 years0/25 (0)1/46 (2)1/71 (1)
 >3-4 years0/10 (0)0/13 (0)0/23 (0)
Patients rolled over to long-term extension study (PCYC-1103)26 (84)69 (68)95 (72)
Patients remaining on ibrutinib treatment25 (81)54 (53)79 (60)
Primary reasons for discontinuation
 Disease progression1 (3)21 (21)22 (17)
 AE3 (10)12 (12)15 (11)
 Consent withdrawal2 (6)4 (4)6 (5)
 Investigator decision09 (9)*9 (7)
 Other01 (1)1 (1)
 Death on study1 (3)13 (13)14 (11)
  • Values are n (%) unless otherwise noted.

  • * Within 30 days of last dose.

  • Including 4 patients who went to stem cell transplant.