POLIVY + R-Benda had an acceptable AE profile vs R-Benda alone^1,2

In a multicentre, randomised, phase II, open-label study of POLIVY + R-Benda vs R-Benda in 80 patients with R/R DLBCL who were not candidates for HSCT:¹

Adapted from Sehn et al. 2020¹ and Sehn et al. 2017.²

• 43.6% of patients had peripheral neuropathy with POLIVY + R-Benda — all instances were grade ≤2 and were usually reversible; two cases led to dose reduction of POLIVY¹
• Patients should be monitored for symptoms of peripheral neuropathy. Patients experiencing new or worsening symptoms may require a delay, dose reduction, or discontinuation of POLIVY³

 See the phase II efficacy results for POLIVY

Cytopenias and infections were the only grade 3–4 AEs that affected ≥10% of patients¹

Adapted from Sehn et al. 2020¹ and Sehn et al. 2017.²

▸ Back to top

Find out how POLIVY works

POLIVY safety profile and considerations

• The most frequently reported (≥30%) ADRs were anaemia (46.7%), thrombocytopenia (46.7%), neutropenia (46.7%), fatigue (40.0%), diarrhoea (37.8%), nausea (33.3%) and pyrexia (33.3%)
• SARs were reported in 27% of patients, which includes febrile neutropenia (6.7%), pyrexia (4.4%) and pneumonia (4.4%)
• Treatment discontinuations due to ADRs in >5% of patients were caused by thrombocytopenia (8.9%) and neutropenia (6.7%)

Dose modifications

• The infusion rate of POLIVY should be slowed or interrupted if a patient develops an IRR
• POLIVY should be discontinued immediately and permanently if the patient experiences a life-threatening reaction

POLIVY dose modifications for peripheral neuropathy³

POLIVY, bendamustine and rituximab dose modifications for myelosuppression³

POLIVY, bendamustine and rituximab dose modifications for IRRs³

▸ Back to top

See the recommended dosing and administration guidance for POLIVY

* POLIVY discontinuation: 12 (30.8%).²

† If primary cause is due to lymphoma, the dose of bendamustine may not need to be reduced.

R-Benda, rituximab and bendamustine; AE, adverse event; MOA, mode of action; ADR, adverse drug reaction; R/R, relapsed/refractory; DLBCL, diffuse large B-cell lymphoma; HSCT, haematopoietic stem cell transplant; SAE, serious adverse event; SAR, serious adverse reaction; IRR, infusion-related reaction; ANC, absolute neutrophil count.

References:

1. Sehn LH et al. J Clin Oncol 2020;38(2):155–165.
2. Sehn LH et al. Poster presented at ASH 2017, poster number 2821.
3. POLIVY Summary of Product Characteristics.

▸ Back to top