When each was combined with Clb in first-line CLL
GAZYVA DEMONSTRATED HIGHER RESPONSE RATES vs RITUXIMAB1
GAZYVA + Clb nearly tripled the complete responsea rate vs rituximab + Clb (28.2% vs 10.3%)
• Overall response rates with GAZYVA + Clb were greater than those with rituximab + Clb (79.6% vs 66.3%)
• GAZYVA + Clb delivered longer median duration of response vs rituximab + Clb (19.6 months vs 9.7 months)
a
Complete response (CR) includes complete response with incomplete marrow recovery (CRi).
ADDITIONAL CLINICAL DATA1
In patients who achieved a complete response,a GAZYVA + Clb increased the rate of minimal
residual disease (MRD) negativityb vs rituximab + Clb
• Bone marrow: 19% (18 of 94 patients) with GAZYVA + Clb vs 6% (2 of 34 patients) with rituximab + Clb
• Peripheral blood: 41% (39 of 94 patients) with GAZYVA + Clb vs 12% (4 of 34 patients) with rituximab + Clb
b
MRD was evaluated using allele-specific oligonucleotide polymerase chain reaction. The cutoff for a negative status was one CLL cell per 104 leukocytes
in the sample (ie, an MRD value of <10-4 was considered negative). Bone marrow samples were collected at the end of treatment, and peripheral blood
samples were collected at least 3 months after the end of treatment.1,2
SELECT CLL-11 SAFETY 1,2
Grade 3/4 adverse reactions were: neutropenia (33%), infusion reactions (20%), thrombocytopenia
(10%), anemia (4%), leukopenia (4%), diarrhea (2%), urinary tract infection (1%), pyrexia (<1%), and
nasopharyngitis (<1%)
• The most common adverse reactions (incidence ≥10%) were: infusion reactions (66%), neutropenia (38%), thrombocytopenia (14%),
nausea (12%), anemia (11%), pyrexia (10%), cough (10%), and diarrhea (10%)
IMPORTANT SAFETY INFORMATION (CONT’D)
Hepatitis B Virus Reactivation (cont’d)
• In patients who develop reactivation of HBV while receiving
GAZYVA, immediately discontinue GAZYVA and any
concomitant chemotherapy and institute appropriate
treatment. Resumption of GAZYVA in patients whose HBV
reactivation resolves should be discussed with physicians
with expertise in managing hepatitis B. Insufficient data exist
regarding the safety of resuming GAZYVA in patients who
develop HBV reactivation
Progressive Multifocal Leukoencephalopathy (PML)
• JC virus infection resulting in PML, which can be fatal, was
observed in patients treated with GAZYVA. Consider the
diagnosis of PML in any patient presenting with new onset or
changes to preexisting neurologic manifestations. Evaluation
of PML includes, but is not limited to, consultation with a
neurologist, brain MRI, and lumbar puncture. Discontinue
GAZYVA therapy and consider discontinuation or reduction
of any concomitant chemotherapy or immunosuppressive
therapy in patients who develop PML
Infusion Reactions
• GAZYVA can cause severe and life-threatening infusion
reactions. Two-thirds of patients experienced a reaction to
the first 10