NOW WITH HEAD-TO-HEAD DATA vs rituximab + Clb
In combination with chlorambucil (Clb) in first-line CLL1
START WITH GAZYVA
CLL-11 Trial Design1,2: CLL-11 was a Phase III, open-label, multicenter, 3-arm, randomized, parallel-group comparative study in patients with previously untreated
CD20-positive CLL and coexisting medical conditions or reduced renal function. Patients with creatinine clearance <30 mL/min or inadequate liver function
were excluded. Patients were treated with chlorambucil control (Arm 1), GAZYVA in combination with chlorambucil (Arm 2), or rituximab in combination with
chlorambucil (Arm 3). The safety and efficacy of GAZYVA was evaluated in a Stage 1 comparison of Arm 1 vs Arm 2 in 356 patients and a Stage 2 comparison of
Arm 2 vs Arm 3 in 663 patients. The primary endpoint was progression-free survival, as evaluated by an independent review committee. Secondary endpoints
included overall response rate, complete response rate, and response duration.
IMPORTANT SAFETY INFORMATION
Hepatitis B Virus Reactivation
• Hepatitis B virus (HBV) reactivation, in some cases resulting
in fulminant hepatitis, hepatic failure, and death, can occur in
patients treated with anti-CD20 antibodies including GAZYVA.
HBV reactivation has been reported in patients who are
hepatitis B surface antigen (HBsAg) positive and in patients
who are HBsAg negative but are hepatitis B core antibody
(anti-HBc) positive. Reactivation has also occurred in patients
who appear to have resolved hepatitis B infection (ie, HBsAg
negative, anti-HBc positive, and hepatitis B surface antibody
[anti-HBs] positive)
• HBV reactivation is defined as an abrupt increase in HBV
replication manifesting as a rapid increase in serum HBV DNA
level, or detection of HBsAg in a person who was previously
HBsAg negative and anti-HBc positive. Reactivation of HBV
replication is often followed by hepatitis, ie, increase in
transaminase levels and, in severe cases, increase in bilirubin
levels, liver failure, and death
• Screen all patients for HBV infection by measuring HBsAg and
anti-HBc before initiating treatment with GAZYVA. For patients
who show evidence of hepatitis B infection (HBsAg positive
[regardless of antibody status] or HBsAg negative but antiHBc positive), consult physicians with expertise in managing
hepatitis B regarding monitoring and consideration for HBV
antiviral therapy
• Monitor patients with evidence of current or prior HBV
infection for clinical and laboratory signs of hepatitis or HBV
reactivation during and for several months following treatment
with GAZYVA
• 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