RESONATETM-2 FRONTLINE DATA
RESONATETM-2 was a multicenter, randomized 1:1, open-label, Phase 3 trial
of IMBRUVICA® vs chlorambucil in frontline CLL/SLL patients ≥65 years (N=269)2,3
Patients with 17p deletion were not included in the RESONATETM-2 trial3
EXTENDED
OVERALL SURVIVAL
PROLONGED
PROGRESSION-FREE
SURVIVAL
IMBRUVICA® significantly extended
OS vs chlorambucil2
IMBRUVICA® significantly extended PFS
vs chlorambucil2,3
Statistically significant
reduction in risk of death2
2,3
56%
HR=0.44
(95% CI: 0.21, 0.92)
41%
2,3
of patients
crossed over to IMBRUVICA®
Estimated survival rates at 24 months
95% IMBRUVICA®
(95% CI: 89, 97)
PRIMARY ENDPOINT: PFS
84% chlorambucil
• Median follow-up was 18 months3
(95% CI: 77, 90)
• IMBRUVICA® median PFS not reached2
SECONDARY ENDPOINT: OS
• Chlorambucil median PFS was 18.9 months
(95% CI: 14.1, 22.0)2
• Median follow-up was 28 months2
• PFS was assessed by an IRC per revised IWCLL criteria3
Adverse reactions ≥20% across CLL/SLL registration studies2
•
•
•
•
Neutropenia
Thrombocytopenia
Anemia
Diarrhea
•
•
•
•
Musculoskeletal pain
Nausea
Rash
Bruising
• Fatigue
• Pyrexia
• Hemorrhage
ADVERSE REACTIONS
SPECIFIC POPULATIONS
The most common adverse reactions (≥20%) in patients with B-cell malignancies
(MCL, CLL/SLL, and WM) were neutropenia‡ (64%), thrombocytopenia‡ (63%),
diarrhea (43%), anemia‡ (41%), musculoskeletal pain (30%), rash (29%), nausea
(29%), bruising (29%), fatigue (27%), hemorrhage (21%), and pyrexia (21%).
Hepatic Impairment - Avoid use in patients with moderate or severe baseline
hepatic impairment. In patients with mild impairment, reduce IMBRUVICA® dose.
Based on adverse reactions and/or laboratory measurements (noted as platelets, neutrophils, or hemoglobin decreased).
*Based on m arket share 2016 July YTD data from IMS.
†
Based on IMS data February 2014 to date.
‡
The most common Grade 3 or 4 non-hematologic adverse reactions (≥5%) in MCL
patients were pneumonia (7%), abdominal pain (5%), atrial fibrillation (5%), diarrhea
(5%), fatigue (5%), and skin infections (5%).
Approximately 6% (CLL/SLL), 14% (MCL), and 11% (WM) of patients had a dose
reduction due to adverse reactions.
Approximately 4%-10% (CLL/SLL), 9% (MCL), and 6% (WM) of patients discontinued
due to adverse reactions. Most frequent adverse reactions leading to discontinuation
were pneumonia, hemorrhage, atrial fibrillation, rash, and neutropenia (1% each)
in CLL/SLL patients and subdural hematoma (1.8%) in MCL patients.
DRUG INTERACTIONS
CYP3A Inhibitors - Avoid coadministration with strong and moderate CYP3A
inhibitors. If a moderate CYP3A inhibitor must be used, reduce the IMBRUVICA® dose.
CYP3A Inducers - Avoid coadministration with strong CYP3A inducers.
To learn more, visit
IMBRUVICAHCP.com
Please see the Brief Summary on the following pages.
CI=confidence interval, CLL=chronic lymphocytic leukemia, HR=hazard ratio, IRC=Independent Review
Committee, IWCLL=International Workshop on CLL, OS=overall survival, PFS=progression-free survival,
SLL=small lymphocytic leukemia.
References: 1. Data on file. Pharmacyclics LLC. 2. IMBRUVICA® (ibrutinib) Prescribing
Information. Pharmacyclics LLC 2016. 3. Burger JA, Tedeschi A, Barr PM, et al; for the
RESONATE-2 Investigators. Ibrutinib as initial therapy for patients with chronic lymphocytic
leukemia. N Engl J Med. 2015;373(25):2425-2437.