Study design
The RESONATE study was a randomised, multicentre, open-label, phase III study that evaluated the efficacy and safety of IMBRUVICA® vs. ofatumumab in firstline patients with R/R CLL/SLL.[1]
Median age[2]
IMBRUVICA® cohort
67 years
(30-86)
Ofatumumab cohort
67 years
(37-88)
Median prior therapies[2]
IMBRUVICA® cohort
3
(1-12)
Ofatumumab cohort
2
(1-13)
Key patient eligibility criteria:[2]
- CLL/SLL diagnosis
- ≥1 prior therapy
- ECOG PS 0-1
- Measurable nodal disease by CT
The RESONATE study included patients with high-risk features[2]
High-risk features included TP53 mutation, del(11q), del(17p) and/or uIGHV
Baseline characteristics[2]
Characteristic | IMBRUVICA® | Ofatumumab |
| Median age (range), years ≥70 years, n (%) | 67 (30–86) 78 (40) | 67 (37–88) 80 (41) |
Male, n (%) | 129 (66) | 137 (70) |
| ECOG performance status, n (%) 0 1 | 79 (41) 116 (59) | 80 (41) 116 (59) |
Rai stage III or IV, n (%) | 109 (56) | 113 (58) |
Bulky disease ≥5 cm, n (%) | 124 (64) | 101 (52) |
Median LDH, unit/L (range) | 232.0 (40.0–1937) | 228.0 (94.0–1301) |
Median β2 microglobulin, mg/L (range) | 5.8 (1.8–20.2) | 5.8 (2.0–17.1) |
| Median number of prior therapies (range) 1 prior therapy, n (%) 2 prior therapies, n (%) ≥3 prior therapies, n (%) | 3 (1–12) 35 (18) 57 (29) 103 (53) | 2 (1–13) 53 (27) 53 (27) 90 (46) |
| Genomic abnormalities, n/N (%) Del(11q) Del(17p) Complex karyotype* IGHV unmutated† NOTCH1 mutation TP53 mutation SF3B1 mutation BIRC3 mutation XPO1 mutation | 63/190 (33) 63/195 (32) 39/153 (25) 98/134 (73) 43/154 (28) 79/154 (51) 47/154 (31) 21/154 (14) 26/154 (17) | 59/191 (31) 64/196 (33) 33/147 (22) 84/133 (63) 45/149 (30) 68/149 (46) 44/149 (30) 15/149 (10) 12/149 (8) |
IMBRUVICA®
420 mg once daily
until disease progression or unacceptable toxicity
(n=195)[1]
.png?width=1280&height=720&format=webp&quality=50 "Randomised 1:1")
Ofatumumab
300 mg at week 1
2000 mg at weeks 2–8
2000 mg at weeks 12, 16, 20, 24
(n=196)[1]
Endpoints[1]
PFS, ORR, OS and safety
65.3 months
extended median follow-up[1]
CLL patient subgroups
uIGHV patients
Genetic aberration patients
Fit patients
Relapsed / refractory patients
Back to IMBRUVICA® studies
*Complex karyotype data were reported by investigator.[2]
†IGHV mutation status was assessed by a central laboratory.[2]
CLL=chronic lymphocytic leukaemia; CT=Computed tomography; ECOG PS=Eastern Cooperative Oncology Group Performance Status; IGHV=immunoglobulin heavy-chain variable region; LDH=lactate dehydrogenase; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; R/R=relapsed/refractory; SLL=small lymphocytic lymphoma; uIGHV=unmutated immunoglobulin heavy-chain variable region.
