EXTENDED OVERALL SURVIVAL
PROLONGED PROGRESSION-FREE SURVIVAL
Adverse reactions ≥20 % across CLL / SLL registration studies 2
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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 not included in the RESONATE TM -2 trial 3
EXTENDED OVERALL SURVIVAL
IMBRUVICA ® significantly extended OS vs chlorambucil 2
Statistically significant reduction in risk of death 2
56 %
HR = 0.44 ( 95 % CI : 0.21 , 0.92 )
PROLONGED PROGRESSION-FREE SURVIVAL
IMBRUVICA ® significantly extended PFS vs chlorambucil 2 , 3
2,3
41 % of patients crossed over to IMBRUVICA ®
2,3
Estimated survival rates at 24 months
95 % IMBRUVICA ® ( 95 % CI : 89 , 97 ) 84 % chlorambucil ( 95 % CI : 77 , 90 )
SECONDARY ENDPOINT : OS
• Median follow-up was 28 months 2
PRIMARY ENDPOINT : PFS
• Median follow-up was 18 months 3
• IMBRUVICA ® median PFS not reached 2
• Chlorambucil median PFS was 18.9 months ( 95 % CI : 14.1 , 22.0 ) 2
• PFS was assessed by an IRC per revised IWCLL criteria 3
Adverse reactions ≥20 % across CLL / SLL registration studies 2
• Neutropenia
• Thrombocytopenia
• Anemia
• Diarrhea
• Musculoskeletal pain
• Nausea
• Rash
• Bruising
• Fatigue
• Pyrexia
• Hemorrhage
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 fi brillation ( 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 fi brillation , 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 .
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 = 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 leukemia .
References : 1 . Data on fi le . 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 .
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