Select Grade 3 or higher adverse reactions in both study arms 1

The safety of POLIVY+BR (n=45) is based on a safety run-in stage trial (n=6) and a randomized trial comparing treatment with BR (n=39) in patients with R/R DBLCL.

The types of adverse events reported in Study GO29365 were consistent compared to control.

The table includes a combination of grouped and ungrouped terms. Events were graded using NCI CTCAE version 4.
*Includes 2 events with fatal outcome.
Includes 1 event with fatal outcome.
NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events.

The adverse drug reactions (all grades; >10% incidence and ≥5% more for all grades in the POLIVY+BR arm) occurring in patients with R/R DLBCL treated with POLIVY+BR or BR were neutropenia (49% vs 44%), thrombocytopenia (49% vs 33%), anemia (47% vs 28%), peripheral neuropathy (40% vs 8%), diarrhea (38% vs 28%), pyrexia (33% vs 23%), decreased appetite (27% vs 21%), pneumonia (22% vs 15%), vomiting (18% vs 13%), infusion-related reaction (18% vs 8%), weight decreased (16% vs 8%), hypokalemia (16% vs 10%), hypoalbuminemia (13% vs 8%), upper respiratory tract infection (13% vs 8%), dizziness (13% vs 8%), lymphopenia (13% vs 8%), and hypocalcemia (11% vs 5%).

Other clinically relevant adverse reactions (<10% or with a <5% difference) in recipients of POLIVY+BR included blood and lymphatic system disorders: pancytopenia (7%); musculoskeletal disorders: arthralgia (7%); investigations: hypophosphatemia (9%), transaminase elevation (7%), lipase increase (7%); and respiratory disorders: pneumonitis (4.4%). 

  • Fatal adverse reactions occurred in 7% in the POLIVY+BR arm within 90 days of last treatment
  • Serious adverse reactions occurred in 64%, most often from infection
  • Serious adverse reactions in ≥5% of recipients of POLIVY+BR included pneumonia (16%), febrile neutropenia (11%), pyrexia (9%), and sepsis (7%)

GO29365 expanded safety data 1

Safety was also evaluated in 173 patients with R/R lymphoma who received POLIVY, bendamustine, and either rituximab product, or obinutuzumab (POLIVY and chemoimmunotherapy), including the 45 patients with DLBCL.

Common Adverse Reactions (≥20% Any Grade and ≥5% Grade 3 or Higher) in Patients Receiving POLIVY + Chemoimmunotherapy for R/R Lymphoma

The table includes a combination of grouped and ungrouped terms.
*Primary prophylaxis with granulocyte colony-stimulating factor was given to 46% of all patients.
Includes 5 events with fatal outcome.
Includes 4 events with fatal outcome.

Other clinically relevant adverse reactions (<20% any grade) included: Infusion-related reaction (7%), upper respiratory tract infection (16%), lower respiratory tract infection (10%), herpesvirus infection (12%), cytomegalovirus infection (1.2%), dyspnea (19%), pneumonitis (1.7%), dizziness (10%), weight decrease (10%), transaminase elevation (8%), lipase increase (3.5%), arthralgia (7%), and blurred vision (1.2%).
Fatal adverse reactions occurred in 4.6% of recipients of POLIVY within 90 days of last treatment, with infection as a leading cause.
Serious adverse reactions occurred in 60% of patients, most often from infection.

Selected laboratory abnormalities worsening from baseline in patients with R/R DLBCL receiving POLIVY+BR and ≥5% greater in the POLIVY+BR arm 1

*Includes laboratory abnormalities that are new or worsening in grade or with worsening from baseline unknown.

Discontinuation rates 1

  • 49% of patients who were treated with POLIVY+BR received 6 cycles (median: 5 cycles) vs 23% of patients treated with BR (median: 3 cycles)
  • In patients receiving POLIVY+BR, adverse reactions leading to dose reduction occurred in 18%, dose interruption in 51%, and permanent discontinuation of all treatment in 31%
  • The most common adverse reactions leading to treatment discontinuation were thrombocytopenia and/or neutropenia

Please see Dose Modifications and full Prescribing Information for recommendations on managing select adverse events.