ASH Clinical News May 2016 | Page 5

In follicular lymphoma patients who were refractory to a rituximab-containing regimen

GADOLIN TRIAL : SECONDARY ENDPOINTS 1

INVESTIGATOR- ASSESSED PFS
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
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 SAFETY 1

• 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 / 010616 / 0005b Printed in USA . March 2016