POLIVY+BR was studied in a randomized trial of patients with DLBCL who had received at least 1 prior therapy

Study GO29365 was a pivotal, phase II, open-label study in patients with previously treated DLBCL (N=80) 1,2

  • Inclusion criteria: Patients with DLBCL who had received at least 1 prior regimen and were not candidates for autologous hematopoietic stem cell transplantation (HSCT) at study entry
  • Exclusion criteria: Patients with Grade 2 or higher peripheral neuropathy, prior allogeneic HSCT, active central nervous system lymphoma, transformed lymphoma

Patients were randomized 1:1 to receive either POLIVY+BR or BR for six 21-day cycles 1

Following premedication with an antihistamine and antipyretic, POLIVY was given by intravenous (IV) infusion at 1.8 mg/kg on Day 2 of cycle 1 and on Day 1 of cycles 2 to 6.*
Bendamustine was dosed at 90 mg/m2 intravenously on Days 2 and 3 of cycle 1 and on Days 1 and 2 of cycles 2 to 6.
Rituximab product was administered at a dose of 375 mg/m2 intravenously on Day 1 of cycles 1 to 6. Each cycle was 21 days in length.

*Dosing protocol in Study GO29365.
Please see the Dosing page and full Prescribing Information for recommended dosing schedule.

Primary Endpoint
Select Additional Endpoints
  • Complete response (CR) as assessed by an independent review committee (IRC)
    • Measured by PET-CT at EOT
  • Objective response rate at EOT (ORR; IRC assessed) 
  • Best overall response of CR or partial remission (PR) 
  • Duration of response (DoR) as assessed by IRC

EOT was defined as 6 to 8 weeks after Day 1 of cycle 6 or last study treatment.
PET-CT results were prioritized over CT results.

PET-CT=positron emission tomography–computed tomography; EOT=end of treatment.

GO29365 studied a range of patients with R/R DLBCL who had received at least 1 prior therapy 1