ASH Clinical News ACN_4.8_Final_digital | 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%) • 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, neutropenia, upper respiratory tract
infection, cough, constipation and diarrhea
• 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 • 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%)
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 Please see additional Important Safety Information
throughout as well as the brief summary of the full
Prescribing Information, including BOXED WARNINGS.
•
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.
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 Printed in USA. May 2018