ASH Clinical News ACN_4.13_full issue_Web | Page 5

Fewer Patients Progressed or Died With the GAZYVA Based
Regimen vs the rituximab-based Regimen 1
With chemotherapy * for stage II bulky, III, and IV patients
Primary Endpoint: PFS (IRC-assessed) 1
GAZYVA based regimen (n=601)
33
FEWER
PATIENTS
progressed
or died
with the
GAZYVA
based
regimen
108 patients
progressed or died
(18%; 38-month
median observation time)
rituximab-based regimen (n=601)
141 patients
progressed or died
(23.5%; 38-month
median observation time)
= approximately 10 patients
HR=0.72, 95% CI, 0.56-0.93; P=0.0118.
PFS is defi ned as survival without progression or death.
Important Safety Information (cont’d)
Additional Important Safety Information Additional Important Safety Information (cont’d)
• A randomized, open-label multicenter trial (GALLIUM)
evaluated the safety of GAZYVA as compared to
rituximab product in 1,385 patients with previously
untreated follicular lymphoma (86%) or marginal zone
lymphoma (14%)
• Serious adverse reactions occurred in 50% of patients
on the GAZYVA arm and 43% of patients on the
rituximab product arm. Fatal adverse reactions were
reported during treatment in 3% in the GAZYVA arm
and 2% in the rituximab product arm, most often
from infections in the GAZYVA arm. During treatment
and follow-up combined, fatal adverse reactions were
reported in 5% of the GAZYVA arm and 4% of the
rituximab product arm, with infections and second
malignancies being leading causes. In the GAZYVA arm,
fatal infections occurred in 2% of patients compared to
<1% in the rituximab product arm
• Neutropenia, infusion related reactions, febrile
neutropenia and thrombocytopenia were the most
common Grade 3 to 5 adverse reactions (incidence ≥5%)
observed more frequently in the GAZYVA arm • Throughout treatment and follow-up, the most common
adverse reactions (incidence ≥20%) observed at least
2% more in the GAZYVA arm were infusion related
reactions (72%), neutropenia (53%), upper respiratory
tract infection (50%), cough (35%), constipation (32%)
and diarrhea (30%)
• During the monotherapy period, the common adverse
reactions (incidence ≥10%) observed at least 2% more
with GAZYVA were upper respiratory infection (40%),
cough (23%), musculoskeletal pain (20%), neutropenia
(19%) and herpesvirus infection (13%)
You are encouraged to report side eff ects to
Genentech and the FDA. You may contact Genentech
by calling 1-888-835-2555. You may contact the FDA
by visiting www.fda.gov/medwatch, or calling
1-800-FDA-1088.
Please see additional Important Safety Information
throughout as well as the brief summary of the full
Prescribing Information, including BOXED WARNINGS.
References: 1. GAZYVA full Prescribing Information. South San Francisco, CA: Genentech, Inc.; 2017. 2. Data on fi le. Genentech, Inc.
Visit GAZYVA.com/FirstandOnly
for more information
© 2018 Genentech USA, Inc. All rights reserved.
GAZ/100917/0047(1)d(1) Printed in USA. October 2018