ASH News Daily 2016 - Issue 3 - A-7
In follicular lymphoma patients who were refractory to a rituximab-containing regimen
GADOLIN TRIAL: SECONDARY ENDPOINTS1
INVESTIGATORASSESSED PFS
BEST OVERALL
RESPONSE
GAZYVA + bendamustine followed by GAZYVA monotherapy more than
doubled the median investigator-assessed PFS vs bendamustine alone
*
29.2 months vs 13.7 months (PFS HR=0.48; 95% CI, 0.35-0.67; P<0.0001)
Best overall response* rates with GAZYVA + bendamustine followed by
GAZYVA monotherapy vs bendamustine alone were 78.7% vs 74.7%,
respectively
*
*
Complete response: 15.5% with GAZYVA + bendamustine followed by GAZYVA monotherapy vs
18.7% with bendamustine alone
Partial response: 63.2% with GAZYVA + bendamustine followed by GAZYVA monotherapy vs
56.0% with bendamustine alone
*
Best response of CR/PR within 12 months of study start.
DURATION
OF RESPONSE
The median duration of response in the bendamustine arm was 11.6
months, but has not yet been reached in the GAZYVA + bendamustine
followed by GAZYVA monotherapy arm
OVERALL
SURVIVAL
In a post hoc analysis with a median observation time of 24.1 months,
GAZYVA + bendamustine followed by GAZYVA monotherapy (n=164)
reduced the risk of death by 38% vs bendamustine alone (n=171)
*
Median not reached in either arm (HR=0.62; 95% CI, 0.39-0.98)
SELECT GADOLIN SAFETY1
*
The safety of GAZYVA was evaluated based on a safety population of 392 patients with indolent NHL (iNHL), of whom 81%
had follicular lymphoma. In patients with follicular lymphoma, the most common adverse reactions that were seen were
consistent with the overall population who had iNHL
*
Grade 3/4 adverse reactions were: neutropenia (33%), infusion reactions (11%), thrombocytopenia (10%), urinary tract
infection (3%), upper respiratory tract infection (2%), pyrexia (1%), asthenia (1%), sinusitis (1%), and pain in extremity (1%)
*
The most common adverse reactions (incidence ≥10%) were: infusion reactions (69%), neutropenia (35%), nausea (54%),
fatigue (39%), cough (26%), diarrhea (27%), constipation (19%), pyrexia (18%), thrombocytopenia (15%), vomiting (22%), upper
respiratory tract infection (13%), decreased appetite (18%), arthralgia (12%), sinusitis (12%), anemia (12%), asthenia (11%), and
urinary tract infection (10%)
*
During the monotherapy period with GAZYVA, the most common Grade 3-4 adverse reactions were neutropenia (10%), and
anemia, febrile neutropenia, thrombocytopenia, sepsis, upper respiratory tract infection, and urinary tract infection (all
at 1%)
*
During the monotherapy period with GAZYVA, the most common adverse reactions were cough (15%), upper respiratory
tract infections (12%), neutropenia (11%), sinusitis (10%), diarrhea (8%), infusion related reactions (8%), nausea (8%),
fatigue (8%), bronchitis (7%), arthralgia (7%), pyrexia (6%), nasopharyngitis (6%), and urinary tract infections (6%)
IMPORTANT SAFETY INFORMATION (CONT'D)
Additional Important Safety Information (cont'd)
* During the monotherapy period with GAZYVA, the most common adverse reactions
were cough (15%), upper respiratory tract infections (12%), neutropenia (11%),
sinusitis (10%), diarrhea (8%), infusion related reactions (8%), nausea (8%), fatigue
(8%), bronchitis (7%), arthralgia (7%), pyrexia (6%), nasopharyngitis (6%), and urinary
tract infections (6%)
Visit GAZYVA.com
for more information
You are encouraged to report side effects 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 the following pages for the brief summary of the full Prescribing Information, including
Boxed WARNINGS.
References: 1. GAZYVA full Prescribing Information. South San Francisco, CA: Genentech USA, Inc.; February 2016.
2. Data on file. Genentech, Inc.
© 2016 Genentech USA, Inc. All rights reserved.
GAZ/082916/0093c Printed in USA. October 2016
10/6/16 2:00 PM
Table of Contents for the Digital Edition of ASH News Daily 2016 - Issue 3
ASH News Daily 2016 - Issue 3 - A-1
ASH News Daily 2016 - Issue 3 - A-2
ASH News Daily 2016 - Issue 3 - A-3
ASH News Daily 2016 - Issue 3 - A-4
ASH News Daily 2016 - Issue 3 - A-5
ASH News Daily 2016 - Issue 3 - A-6
ASH News Daily 2016 - Issue 3 - A-7
ASH News Daily 2016 - Issue 3 - A-8
ASH News Daily 2016 - Issue 3 - A-9
ASH News Daily 2016 - Issue 3 - A-10
ASH News Daily 2016 - Issue 3 - A-11
ASH News Daily 2016 - Issue 3 - A-12
ASH News Daily 2016 - Issue 3 - A-13
ASH News Daily 2016 - Issue 3 - A-14
ASH News Daily 2016 - Issue 3 - A-15
ASH News Daily 2016 - Issue 3 - A-16
ASH News Daily 2016 - Issue 3 - A-17
ASH News Daily 2016 - Issue 3 - A-18
ASH News Daily 2016 - Issue 3 - A-19
ASH News Daily 2016 - Issue 3 - A-20
ASH News Daily 2016 - Issue 3 - A-21
ASH News Daily 2016 - Issue 3 - A-22
ASH News Daily 2016 - Issue 3 - A-23
ASH News Daily 2016 - Issue 3 - A-24
ASH News Daily 2016 - Issue 3 - A-25
ASH News Daily 2016 - Issue 3 - A-26
ASH News Daily 2016 - Issue 3 - B-1
ASH News Daily 2016 - Issue 3 - B-2
ASH News Daily 2016 - Issue 3 - B-3
ASH News Daily 2016 - Issue 3 - B-4
ASH News Daily 2016 - Issue 3 - B-5
ASH News Daily 2016 - Issue 3 - B-6
ASH News Daily 2016 - Issue 3 - B-7
ASH News Daily 2016 - Issue 3 - B-8
ASH News Daily 2016 - Issue 3 - B-9
ASH News Daily 2016 - Issue 3 - B-10
ASH News Daily 2016 - Issue 3 - B-11
ASH News Daily 2016 - Issue 3 - B-12
ASH News Daily 2016 - Issue 3 - B-13
ASH News Daily 2016 - Issue 3 - B-14
ASH News Daily 2016 - Issue 3 - B-15
ASH News Daily 2016 - Issue 3 - B-16
ASH News Daily 2016 - Issue 3 - B-17
ASH News Daily 2016 - Issue 3 - B-18
ASH News Daily 2016 - Issue 3 - B-19
ASH News Daily 2016 - Issue 3 - B-20
ASH News Daily 2016 - Issue 3 - B-21
ASH News Daily 2016 - Issue 3 - B-22
ASH News Daily 2016 - Issue 3 - B-23
ASH News Daily 2016 - Issue 3 - B-24
ASH News Daily 2016 - Issue 3 - B-25
ASH News Daily 2016 - Issue 3 - B-26
ASH News Daily 2016 - Issue 3 - B-27
ASH News Daily 2016 - Issue 3 - B-28
ASH News Daily 2016 - Issue 3 - B-29
ASH News Daily 2016 - Issue 3 - B-30
ASH News Daily 2016 - Issue 3 - B-31
ASH News Daily 2016 - Issue 3 - B-32
ASH News Daily 2016 - Issue 3 - B-33
ASH News Daily 2016 - Issue 3 - B-34
ASH News Daily 2016 - Issue 3 - B-35
ASH News Daily 2016 - Issue 3 - B-36
ASH News Daily 2016 - Issue 3 - B-37
ASH News Daily 2016 - Issue 3 - B-38
ASH News Daily 2016 - Issue 3 - B-39
ASH News Daily 2016 - Issue 3 - B-40
ASH News Daily 2016 - Issue 3 - B-41
ASH News Daily 2016 - Issue 3 - B-42
ASH News Daily 2016 - Issue 3 - B-43
ASH News Daily 2016 - Issue 3 - B-44
ASH News Daily 2016 - Issue 3 - B-45
ASH News Daily 2016 - Issue 3 - B-46
ASH News Daily 2016 - Issue 3 - B-47
ASH News Daily 2016 - Issue 3 - B-48
ASH News Daily 2016 - Issue 3 - C-1
ASH News Daily 2016 - Issue 3 - C-2
ASH News Daily 2016 - Issue 3 - C-3
ASH News Daily 2016 - Issue 3 - C-4
ASH News Daily 2016 - Issue 3 - C-5
ASH News Daily 2016 - Issue 3 - C-6
ASH News Daily 2016 - Issue 3 - C-7
ASH News Daily 2016 - Issue 3 - C-8
ASH News Daily 2016 - Issue 3 - C-9
ASH News Daily 2016 - Issue 3 - C-10
ASH News Daily 2016 - Issue 3 - C-11
ASH News Daily 2016 - Issue 3 - C-12
ASH News Daily 2016 - Issue 3 - C-13
ASH News Daily 2016 - Issue 3 - C-14
ASH News Daily 2016 - Issue 3 - C-15
ASH News Daily 2016 - Issue 3 - C-16
ASH News Daily 2016 - Issue 3 - C-17
ASH News Daily 2016 - Issue 3 - C-18
ASH News Daily 2016 - Issue 3 - C-19
ASH News Daily 2016 - Issue 3 - C-20
ASH News Daily 2016 - Issue 3 - C-21
ASH News Daily 2016 - Issue 3 - C-22
ASH News Daily 2016 - Issue 3 - C-23
ASH News Daily 2016 - Issue 3 - C-24
ASH News Daily 2016 - Issue 3 - C-25
ASH News Daily 2016 - Issue 3 - C-26
https://www.nxtbookmedia.com