IMBRUVICA® demonstrated single-agent survival in
previously treated CLL
INDICATIONS: IMBRUVICA® is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor indicated for
the treatment of patients with:
• Chronic lymphocytic leukemia (CLL) who have received at least one prior therapy
• CLL with 17p deletion
Superior overall survival (OS) with IMBRUVICA® vs ofatumumab—secondary endpoint
(HR=0.43; 95% CI: 0.24, 0.79); P<0.05
• 57% statistically significant reduction in the risk of death for patients in the IMBRUVICA® arm
• Median OS not yet reached in either treatment arm
Superior progression-free survival (PFS) with IMBRUVICA® vs ofatumumab—
primary endpoint
• Median PFS not yet reached with IMBRUVICA® vs 8.1 months with ofatumumab
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78% statistically significant reduction in the risk
of death or progression (independent review)
100
PFS (%)
80
60
40
20
0
Ofatumumab
P<0.0001 by log-rank test
0
3
6
Number at risk
IMBRUVICA® 195
Ofatumumab 196
183
161
116
83
Months
9
12
15
(HR for progression or death: 0.22;
95% CI: 0.15, 0.32); P<0.0001
Results from the randomized, multicenter,
open-label, Phase 3 RESONATE™ trial of IMBRUVICA®
vs ofatumumab in patients with previously treated
CLL. Patients (N=391) were randomized 1:1 to
receive either IMBRUVICA® 420 mg orally daily
until disease progression or unacceptable toxicity
or IV ofatumumab at an initial dose of 300 mg,
followed 1 week later by a dose of 2000 mg
weekly for 7 doses, and then every 4 weeks for
4 additional doses. Fifty-seven patients randomized
to ofatumumab crossed over following Independent
Review Committee (IRC)-confirmed progression
to receive IMBRUVICA®. Primary endpoint: PFS
as assessed by an IRC according to modified
International Workshop on CLL Criteria.
HR=hazard ratio.
38
15
7
1
0
0
In patients with previously treated del 17p CLL, IMBRUVICA® demonstrated a 75%
reduced risk of progression or death (HR=0.25; 95% CI: 0.14, 0.45)
• Median PFS not reached with IMBRUVICA® (n=63) vs 5.8 months with ofatumumab (n=64)
Oral, once-daily dosing
In CLL studies, approximately 5% of patients discontinued due to adverse events
Please review the Important Safety Information on adjacent page.