RESONATE TM -2 FRONTLINE DATA
RESONATE TM -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 excluded 3
EXTENDED
OVERALL SURVIVAL 2 PROLONGED
PROGRESSION-FREE SURVIVAL 2,3
• Median follow-up was 28 months 2
• Fewer deaths with IMBRUVICA® were observed; 11 (8.1%) in the IMBRUVICA®
arm vs 21 (15.8%) in the chlorambucil arm 2 • Median follow-up was 18 months 3
• With IMBRUVICA®, median PFS was not estimable vs 18.9 months
(95% CI: 14.1, 22.0) with chlorambucil 2
• PFS and ORR (CR and PR) were assessed by an IRC according to
the revised 2008 iwCLL criteria 3
SECONDARY ENDPOINT: OS
IMBRUVICA® vs CHLORAMBUCIL
PRIMARY ENDPOINT: PFS
IMBRUVICA® vs CHLORAMBUCIL
RESONATE™-2 Adverse Reactions ≥15%
• Diarrhea (42%)
• Musculoskeletal pain (36%)
• Cough (22%)
• Rash (21%)
• Bruising (19%)
• Peripheral edema (19%)
Embryo-Fetal Toxicity: Based on fi ndings in animals, IMBRUVICA ® can
cause fetal harm when administered to a pregnant woman. Advise women
to avoid becoming pregnant while taking IMBRUVICA ® and for 1 month after
cessation of therapy. If this drug is used during pregnancy or if the patient
becomes pregnant while taking this drug, the patient should be apprised of the
potential hazard to a fetus. Advise men to avoid fathering a child during
the same time period.
ADVERSE REACTIONS
The most common adverse reactions (≥20%) in patients with B-cell
malignancies (MCL, CLL/SLL, WM and MZL) were thrombocytopenia
(58%)*, neutropenia (58%)*, diarrhea (42%), anemia (39%)*, rash (31%),
musculoskeletal pain (31%), bruising (31%), nausea (28%), fatigue (27%),
hemorrhage (23%), and pyrexia (20%).
The most common Grade 3 or 4 adverse reactions (≥5%) in patients with
B-cell malignancies (MCL, CLL/SLL, WM and MZL) were neutropenia (36%)*,
thrombocytopenia (15%)*, and pneumonia (10%).
Approximately 7% of patients discontinued IMBRUVICA ® due to adverse
reactions. Adverse reactions leading to discontinuation included hemorrhage
(1.2%), atrial fi brillation (1.0%), pneumonia (1.0%), rash (0.7%), diarrhea (0.6%),
neutropenia (0.6%), sepsis (0.5%), interstitial lung disease (0.3%), bruising
(0.2%), non-melanoma skin cancer (0.2%), and thrombocytopenia (0.2%). Eight
percent of patients had a dose reduction due to adverse reactions.
* Treatment-emergent decreases (all grades) were based on laboratory measurements and
adverse reactions.
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• Pyrexia (17%)
• Dry eye (17%)
• Arthralgia (16%)
• Skin infection (15%)
DRUG INTERACTIONS
CYP3A Inhibitors: Dose adjustments may be recommended.
CYP3A Inducers: Avoid coadministration with strong CYP3A inducers.
SPECIFIC POPULATIONS
Hepatic Impairment (based on Child-Pugh criteria): Avoid use of IMBRUVICA ®
in patients with severe baseline hepatic impairment. In patients with mild or
moderate impairment, reduce IMBRUVICA ® dose.
Please see the Brief Summary on the following pages.
CI=confi dence 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 lymphoma.
References: 1. Data on fi le. Pharmacyclics LLC. 2. IMBRUVICA ® (ibrutinib)
Prescribing Information. Pharmacyclics LLC 2018. 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.