ASH Clinical News November 2016 | Page 5

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

OVERALL
SURVIVAL

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
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/082916/0093a Printed in USA. October 2016