ASH Clinical News ACN_4.6_SUPP_DIGITAL | Page 12

Efficacy and safety information of VENCLEXTA
for CLL patients with 17p deletion who have received at least one prior therapy 1
Patients treated with VENCLEXTA ™ monotherapy
achieved over 80% ORR—including complete remissions
• Results per IRC of an open-label,
ORR per independent review committee (IRC)
100
80
single-arm, multicenter clinical trial of
106 previously treated CLL patients with
17p deletion who had received at least
one prior therapy
80.2%
(95% CI: 71.3-87.3)
(n=85)
7.5% (n=8)
COMPLETE
REMISSION
(CR + CRi)
5.7% (n=6)
1.9% (n=2)
2.8% (n=3)
60
• Median number of prior therapies was
2.5 (range: 1-10) and median time on
treatment at time of evaluation was
12.1 months
69.8% (n=74)
• Efficacy was evaluated by ORR
CR
40
(CR+CRi+nPR+PR) as assessed by IRC
using the iwCLL NCI-WG guidelines
CRi
nPR
20
• 17p deletion was confirmed in peripheral
PR
0
blood specimens from patients
• Patients received VENCLEXTA via a
Previously treated CLL with 17p deletion (N=106)
Rapid response in patients who responded to VENCLEXTA
0.8
weekly ramp-up schedule starting at
20 mg and ramping to 50 mg, 100 mg,
200 mg to 400 mg once daily until disease
progression or unacceptable toxicity
Median time to first response was less than 1 month (range: 0.1 to 8.1 months)*
months
* Per IRC assessment (n=85). Time to first response: The number of days from date of first dose to the date of the first sign of response (CR, CRi, nPR, or PR). 2
Important Safety Information
Neutropenia
Contraindication
• Concomitant use of VENCLEXTA with strong CYP3A inhibitors at
initiation and during ramp-up phase is contraindicated. a
Tumor Lysis Syndrome
• Tumor lysis syndrome (TLS), including fatal events and renal failure
requiring dialysis, has occurred in previously treated CLL patients with
high tumor burden treated with VENCLEXTA.
• VENCLEXTA poses a risk for TLS in the initial 5-week ramp-up phase.
Changes in blood chemistries consistent with TLS that require prompt
management can occur as early as 6 to 8 hours following the first
dose of VENCLEXTA and at each dose increase.
• Patients should be assessed for TLS risk, including evaluation of
tumor burden and comorbidities, and should receive appropriate
prophylaxis for TLS, including hydration and anti-hyperuricemics.
Reduced renal function (CrCl <80 mL/min) further increases the risk.
Monitor blood chemistries and manage abnormalities promptly.
Interrupt dosing if needed. Employ more intensive measures (IV
hydration, frequent monitoring, hospitalization) as overall risk
increases.
• Concomitant use of VENCLEXTA with strong or moderate CYP3A
inhibitors and P-gp inhibitors may increase the risk of TLS at initiation
and during the ramp-up phase, and may require dose adjustment due
to increases in VENCLEXTA exposure.
• Grade 3 or 4 neutropenia occurred in 41% (98/240) of patients
treated with VENCLEXTA. Monitor complete blood counts
throughout treatment. Interrupt dosing or reduce dose for
severe neutropenia. Consider supportive measures including
antimicrobials for signs of infection and use of growth factors
(e.g., G-CSF).
Immunization
• Do not administer live attenuated vaccines prior to, during, or
after treatment with VENCLEXTA until B-cell recovery. Advise
patients that vaccinations may be less effective.
Embryo-Fetal Toxicity
• VENCLEXTA may cause embryo-fetal harm when administered
to a pregnant woman. Advise females of reproductive
potential to avoid pregnancy during treatment.
Adverse Reactions
• Serious adverse reactions were reported in 43.8% of patients.
The most frequent serious adverse reactions (≥2%) were
pneumonia (5%), febrile neutropenia (4.6%), pyrexia (3.3%),
autoimmune hemolytic anemia (2.9%), anemia (2.1%), and
TLS (2.1%). b
• The most common adverse reactions (≥20%) of any grade
were neutropenia (45%), diarrhea (35%), nausea (33%),
anemia (29%), upper respiratory tract infection (22%),
thrombocytopenia (22%), and fatigue (21%). a
VENCLEXTA™ is a trademark of AbbVie, Inc.
Distributed and marketed by AbbVie, Inc., 1 North Waukegan Road, North Chicago, IL 60064
Marketed by Genentech USA, Inc., 1 DNA Way, South San Francisco, CA 94080-4990
©2017 AbbVie, Inc. and Genentech USA, Inc. 750-1930518/November 2017 Printed in USA