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*Modified Lugano 2014 criteria: PET-CR requires negative bone marrow; PET-PR required CT criteria be met.
DOR, duration of response; IRC, independent review committee
Phase 2 Study Design
R/R FL
N=80
Pola-BR
BR
R/R DLBCL
N=80
Pola-BR
BR
Stratification
DOR ≤12 mo vs >12 mo
High vs low disease burden
DOR ≤12 mo vs >12 mo
Schedule
FL: 28-day cycles × 6
DLBCL: 21-day cycles × 6
Polatuzumab vedotin (1.8 mg/kg IV × 1 day); bendamustine (90 mg/m
2
IV
× 2 days); rituximab (375 mg/m
2
IV × 1 day)
Primary endpoint PET-CR* by IRC, 6–8 weeks post end of treatment (EOT)
1:1 Randomization
89