RITUXAN HYCELA CLINICAL DEVELOPMENT PROGRAM : SABRINA , MabEASE , ANDSAWYERPIVOTALTRIALS 2
SABRINA Phase III Trial : Previously untreated FL ( N = 410 )
ê Trial Design : RITUXAN HYCELA a + CHOP or CVP followed by RITUXAN HYCELA maintenance vs RITUXAN ® ( rituximab ) b + CHOP or CVP followed by RITUXAN maintenance ( 1:1 randomization )
ê Stage 1 Result : RITUXANHYCELAachievednon-inferiorrituximabC trough levels compared to RITUXAN at Cycle 7
ê Stage 2 Result : Investigator-assessedoverallresponseratesattheendofcombinationtreatmentwithchemotherapywere comparablebetweenRITUXANHYCELAandRITUXAN ( 84 % [ 79 ; 89 ] vs85 % [ 79 ; 90 ], respectively ) a
PatientsreceivedonecycleofRITUXAN375mg / m 2 followed by 7 cycles of RITUXAN HYCELA 1,400 mg / 23,400 Units every 3 weeks in combination with a total of 6-8cyclesofCHOPor8cyclesofCVPchemotherapy . b PatientsreceivedRITUXAN375mg / m 2 for8cyclesevery3weeksincombinationwithatotalof6-8cycles of CHOP or 8 cycles of CVP chemotherapy .
MabEASE Phase IIIb Trial : PreviouslyuntreatedDLBCL ( N = 576 )
ê Trial Design : RITUXAN HYCELA c + CHOP vs RITUXAN d + CHOP ( 2:1 randomization )
ê Primary Endpoint Result : Investigator-assessedcompleteresponserate ( CR , CRu ) attheendofcombinationtreatmentwith chemotherapywascomparablebetweenRITUXANHYCELAandRITUXAN ( 47 % [ 42 ; 52 ] vs42 % [ 35 ; 49 ], respectively ) c
PatientsreceivedonecycleofRITUXAN375mg / m 2 followedby7cyclesofRITUXANHYCELA1,400mg / 23,400Units , incombinationwithupto6-8cyclesof CHOP chemotherapy every 14 or 21 days . d PatientsreceivedRITUXAN375mg / m 2 for8cyclesincombinationwithupto6-8cyclesofCHOPevery14or21days . Median observation time was ~ 28 months .
SAWYER Phase Ib Trial : Previously untreated CLL ( N = 176 )
ê Trial Design : RITUXAN HYCELA e + FC vs RITUXAN f + FC ( 1:1 randomization ) ê Primary Endpoint Result : RITUXANHYCELAachievednon-inferiorrituximabC trough levels compared to RITUXAN
EachinitialdoseofRITUXANwas375mg / m 2 . e InCycles2-6 , eachdoseofRITUXANHYCELAwas1,600mg / 26,800Units . f
InCycles2-6 , RITUXANwasdosedat500mg / m 2 .
IMPORTANTSAFETYINFORMATION ( CONT ’ D )
Bowel Obstruction and Perforation
ê Abdominalpain , bowelobstruction , andperforation , insomecasesleadingtodeath , canoccurinpatientsreceivingrituximabcontaining products , including RITUXAN HYCELA , in combination with chemotherapy . Evaluate if symptoms of obstruction such as
abdominal pain or repeated vomiting occur
Immunization
ê Thesafetyofimmunizationwithliveviralvaccinesfollowingrituximab-containingproducts , includingRITUXANHYCELA , hasnotbeen studied and vaccination with live virus vaccines is not recommended before or during treatment
Embryo-Fetal Toxicity
ê Basedonhumandata , rituximab-containingproductscancausefetalharmduetoB-celllymphocytopeniaininfantsexposedtorituximab in-utero . Advisepregnantwomenoftherisktoafetus . Femalesofchildbearingpotentialshoulduseeffectivecontraceptionwhile
receivingRITUXANHYCELAandfor12monthsfollowingthelastdoseofrituximab-containingproducts , includingRITUXANHYCELA
ADVERSE REACTIONS
ê Themostcommonadversereactions ( ≥20 %) ofRITUXANHYCELAobservedinpatientswithFLinSABRINAwere : infections , neutropenia , nausea , constipation , cough , and fatigue
ê Themostcommonadversereactions ( ≥20 %) ofRITUXANHYCELAobservedinpatientswithDLBCLinMabEASEwere : infections , neutropenia , alopecia , nausea , and anemia
ê Themostcommonadversereactions ( ≥20 %) ofRITUXANHYCELAobservedinpatientswithCLLinpart2ofSAWYERwere : infections , neutropenia , nausea , thrombocytopenia , pyrexia , vomiting , and injection site erythema
PREGNANCY AND LACTATION
ê Basedonhumandata , rituximab-containingproductscancauseadversedevelopmentaloutcomesincludingB-celllymphocytopeniain infantsexposedtorituximabin-utero . Advisepregnantwomenoftherisktoafetus
ê Advise lactating women not to breastfeed during treatment and for at least 6 months after the last dose of RITUXAN HYCELA due to the potential for serious adverse reactions in breastfed infants
Please see the following pages for additional Important Safety Information and the brief summary of the full Prescribing Information , including BOXED WARNINGS .