Page 111 - 2017 V1 InsideOut

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
PROLONGED
OVERALL SURVIVAL
PROGRESSION-FREE
IMBRUVICA® significantly extended OS vs chlorambucil2
SURVIVAL
Statistically significant reduction in risk of death2
IMBRUVICA® significantly extended PFS vs chlorambucil2,3
56%
2,3
HR=0.44 (95% CI: 0.21, 0.92)
41% of patients crossed over to IMBRUVICA®
Estimated survival rates at 24 months
95% IMBRUVICA® (95% CI: 89, 97)
84% chlorambucil (95% CI: 77, 90)
2,3
SECONDARY ENDPOINT: OS
• Median follow-up was 28 months2
• Median follow-up was 18 months3
• IMBRUVICA® median PFS not reached2
• Chlorambucil median PFS was 18.9 months (95% CI: 14.1, 22.0)2
Adverse reactions ≥20% across CLL/SLL registration studies2
PRIMARY ENDPOINT: PFS
• PFS was assessed by an IRC per revised IWCLL criteria3
• Neutropenia
• Thrombocytopenia • Anemia
• Diarrhea
• Musculoskeletal pain • Nausea
• Rash
• Bruising
• Fatigue
• Pyrexia
• Hemorrhage
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.
ADVERSE REACTIONS
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%).
‡Based on adverse reactions and/or laboratory measurements (noted as platelets, neutrophils, or hemoglobin decreased).
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.
To learn more, visit
IMBRUVICAHCP.com
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.
SPECIFIC POPULATIONS
Hepatic Impairment - Avoid use in patients with moderate or severe baseline hepatic impairment. In patients with mild impairment, reduce IMBRUVICA® dose.
Please see the Brief Summary on the following pages.
*Based on market share 2016 July YTD data from IMS. †Based on IMS data February 2014 to date.
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.
© Pharmacyclics LLC 2016 © Janssen Biotech, Inc. 2016 10/16 PRC-02242