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Higher Complete Response Rates With Polatuzumab Vedotin , Bendamustine , and Rituximab Combo in DLBCL
Adding polatuzumab vedotin ( an antibodydrug conjugate targeting CD79b-positive cells ) to the combination of bendamustine and rituximab ( BR ) extended survival and increased complete responses ( CRs ) in patients with relapsed and refractory diffuse
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Dosing Instructions Inform patients on how to take POMALYST [ see Dosage and Administration ( 2.1 )]
• POMALYST should be taken once daily at about the same time each day .
• Patients on hemodialysis should take POMALYST following hemodialysis , on hemodialysis days .
• POMALYST may be taken with or without food .
• The capsules should not be opened , broken , or chewed . POMALYST should be swallowed whole with water .
• Instruct patients that if they miss a dose of POMALYST , they may still take it up to 12 hours after the time they would normally take it . If more than 12 hours have elapsed , they should be instructed to skip the dose for that day . The next day , they should take POMALYST at the usual time . Warn patients not to take 2 doses to make up for the one that they missed . large B-cell lymphoma ( DLBCL ), according to results from a phase II trial presented at the 23rd Congress of the European Hematology Association .
These improvements were seen with “ acceptable toxicity ” compared with BR
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POM _ HCP _ BSv . 009 04 / 2018 alone , the researchers , led by Laurie Sehn , MD , from the BC Cancer Agency in Vancouver , British Columbia , Canada , reported .
The study included transplant-ineligible patients with follicular lymphoma ( FL ; n = 80 ) and DLBCL ( n = 80 ). All participants were randomized to receive intravenous bendamustine 90 mg / m 2 and rituximab 375 mg / m 2 alone ( n = 41 in FL and n = 40 in DLBCL ), or with polatuzumab vedotin 1.8 mg / kg ( n = 39 in FL ; n = 40 in DLBCL ). In the FL group , treatment was administered in six 28-day cycles ; in the DLBCL group , treatment was administered in six 21-day cycles .
An independent review committee assessed CR ( using the modified Lugano criteria ) as determined by PET scan approximately six to eight weeks following treatment ( primary endpoint ).
In the FL cohort , median age was 65 years and 63 years ( ranges not reported ) in the polatuzumab vedotin and BR-alone groups , respectively . Forty-one percent and 42 percent , respectively , were refractory to last therapy and the median number of prior therapies was two ( range not reported ).
In the DLBCL cohort , median age was 67 years and 71 years ( ranges not reported ) in the polatuzumab vedotin and BR-alone groups , respectively . Twentynine percent and 32 percent , respectively , were refractory to their last therapy and , again , the median number of prior therapies was two ( range not reported ).
In her presentation , Dr . Sehn highlighted the grade 3-5 adverse events ( AEs ) that occurred more frequently in the polatuzumab vedotin groups , compared with BR alone : cytopenias and febrile neutropenia in both disease groups and infections in the FL group . Grade 5 AEs appeared to occur more frequently in the FL group ( 5 % in FL and 18 % in DLBCL ).
“ There were no unexpected toxicities [ with the polatuzumab vedotin combination ], so it was typical for what we would expect with what is known with this drug alone and BR alone ,” Dr . Sehn said .
At a median follow-up of 15 months ( range not reported ), rates of progressionfree survival ( PFS ) and PET-confirmed CR were similar among patients in the FL group . However , in the DLBCL group , the addition of polatuzumab vedotin to BR significantly increased all efficacy outcomes : PET-CR ( p = 0.012 ), median PFS ( p < 0.0001 ), and median overall survival ( OS ; p = 0.0008 ; see TABLE ).
The researchers also observed apparent differences in PFS and OS in patients with DLBCL receiving polatuzumab vedotin versus BR alone , regardless of patients ’ prior treatment or disease status ( p values not reported ):
• secondline therapy ( PFS : 11.1 months vs . 3.7 months ; OS : not reached for either )
• thirdline plus therapy ( PFS : 6.0 months vs . 2.0 months ; OS : 11.5 months vs . 3.8 months )
July 2018 Bonus Mid-Year Edition