POLIVY is an antibody-drug conjugate (ADC) targeted to CD79b, which is ubiquitously expressed on the surface of B-cell lymphomas1
Specialist views covering a range of POLARIX trial topics
Dr Hervé Tilly
University of Rouen, France
Prof. Christopher Flowers
MD, Anderson Cancer Center, University of Texas
Dr Franck Morschhauser
MD, PhD Professor of Hematology,
University of Lille
Dr Laurie H. Sehn
MD, MPH Clinical Assistant
Professor with the BC Cancer Agency and University
of British Columbia
POLIVY (polatuzumab vedotin) in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) is indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL).1
POLIVY in combination with bendamustine and rituximab is indicated for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant.1
Polatuzumab vedotin is a CD79b-targeted antibody-drug conjugate that preferentially delivers a potent anti-mitotic agent (monomethyl auristatin E, or MMAE) to B-cells, which results in the killing of dividing B-cells.1
The polatuzumab vedotin molecule consists of MMAE covalently attached to a humanised immunoglobulin G1 monoclonal antibody via a cleavable linker.1
POLIVY must only be administered under the supervision of a healthcare professional experienced in the diagnosis and treatment of cancer patients.1
In previously untreated patients with DLBCL1:
1.8 mg/kg
recommended dose
Intravenous infusion
method of administration
Every 21 days
in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for 6 cycles
POLIVY should be administered as an intravenous infusion through a dedicated infusion line equipped with a sterile, non-pyrogenic, low-protein binding in-line or add-on filter (0.2 or 0.22 micrometer pore size) and catheter.1
POLIVY must not be administered as intravenous push or bolus.1
90-minute initial IV infusion
Monitor patients for infusion-related reactions during the infusion and for a minimum of 90 minutes following completion of the initial dose.1
30-minute subsequent infusions
Subsequent infusions may be administered if the initial infusion was well tolerated. Monitor patients during these infusions and for 30 minutes after completion.1
The infusion rate of POLIVY should be slowed or interrupted if the patient develops an infusion-related reaction.1
POLIVY should be discontinued immediately and permanently if the patient experiences a life-threatening reaction.1
There are different potential dose modifications for POLIVY in patients with previously untreated DLBCL and those who are relapsed or refractory.1
| Indication | Severity of PN on Day 1 of any cycle | Dose modification |
| Previously untreated DLBCL | Grade 2* | Sensory neuropathy: • Reduce POLIVY to 1.4 mg/kg • If Grade 2 persists or recurs at Day 1 of a future cycle, reduce POLIVY to 1.0 mg/kg • If already at 1.0 mg/kg and Grade 2 occurs at Day 1 of a future cycle, discontinue POLIVY
Motor neuropathy: • Withhold POLIVY dosing until improvement to Grade ≤ 1 • Restart POLIVY at the next cycle at 1.4 mg/kg • If already at 1.4 mg/kg and Grade 2 occurs at Day 1 of a future cycle, withhold POLIVY dosing until improvement to Grade ≤ 1 Restart POLIVY at 1.0 mg/kg • If already at 1.0 mg/kg and Grade 2 occurs at Day 1 of a future cycle, discontinue POLIVY
If concurrent sensory and motor neuropathy, follow the most severe restriction recommendation above. |
| Grade 3* | Sensory neuropathy: • Withhold POLIVY dosing until improvement to Grade ≤ 2 • Reduce POLIVY to 1.4 mg/kg • If already at 1.4 mg/kg, reduce POLIVY to 1.0 mg/kg. If already at 1.0 mg/kg, discontinue POLIVY
Motor neuropathy: • Withhold POLIVY dosing until improvement to Grade ≤ 1 • Restart POLIVY at the next cycle at 1.4 mg/kg • If already at 1.4 mg/kg and Grade 2–3 occurs, withhold POLIVY dosing until improvement to Grade ≤ 1 Restart POLIVY at 1.0 mg/kg • If already at 1.0 mg/kg and Grade 2–3 occurs, discontinue POLIVY
If concurrent sensory and motor neuropathy, follow the most severe restriction recommendation above. | |
| Grade 4 | Discontinue POLIVY. | |
| R/R DLBCL | Grade 2-3 | Withhold POLIVY dosing until improvement to ≤ Grade 1. If recovered to Grade ≤ 1 on or before Day 14, restart POLIVY at a permanently reduced dose of 1.4 mg/kg. If a prior dose reduction to 1.4 mg/kg has occurred, discontinue POLIVY. If not recovered to Grade ≤ 1 on or before Day 14, discontinue POLIVY. |
| Grade 4 | Discontinue POLIVY. |
| Indication | Severity of myelosuppression on Day1 of any cycle
| Dose modification |
| Previously untreated DLBCL | Grade 3–4 Neutropenia | Withhold all treatment until ANC* recovers to > 1000/ μL. If ANC recovers to > 1000/ μL on or before Day 7, resume all treatment without any dose reductions. If ANC recovers to > 1000/ μL after Day 7: • Resume all treatment; consider a dose reduction of cyclophosphamide and/or doxorubicin by 25—50% • If cyclophosphamide and/or doxorubicin are already reduced by 25%, consider reducing one or both agents to 50% |
Grade 3–4 Thrombocytopenia | Withhold all treatment until platelets recover to > 75,000/ μL. If platelets recover to > 75,000/ μL on or before Day 7, resume all treatment without any dose reductions. If platelets recover to > 75,000/ μL after Day 7: • Resume all treatment; consider a dose reduction of cyclophosphamide and/or doxorubicin by 25—50% • If cyclophosphamide and/or doxorubicin are already reduced by 25%, consider reducing one or both agents to 50% | |
| R/R DLBCL | Grade 3–4 Neutropenia* | Withhold all treatment until ANC recovers to > 1000/ μL. If ANC recovers to > 1000/ μL on or before Day 7, resume all treatment without any additional dose reductions. If ANC recovers to > 1000/ μL after Day 7: • Restart all treatment with a dose reduction of bendamustine from 90 mg/m 2 to 70 mg/m 2 or 70 mg/m 2 to 50 mg/m 2 • If a bendamustine dose reduction to 50 mg/m 2 has already occurred, discontinue all treatment |
Grade 3–4 Thrombocytopenia* | Withhold all treatment until platelets recover to > 75,000/ μL. If platelets recover to > 75,000/ μL on or before Day 7, resume all treatment without any dose reductions. If platelets recover to > 75,000/ μL after Day 7: • Restart all treatment with a dose reduction of bendamustine from 90 mg/m 2 to 70 mg/m 2 or 70 mg/m 2 to 50 mg/m 2 • If a bendamustine dose reduction to 50 mg/m 2 has already occurred, discontinue all treatment |
| Indication | Severity of IRR on Day 1 of any cycle | Dose modification |
Previously untreated and R/R DLBCL | Grade 1—3 IRR | Interrupt POLIVY infusion and give support treatment.
For the first instance of Grade 3 wheezing, bronchospasm, or generalised urticaria, permanently discontinue POLIVY.
For recurrent Grade 2 wheezing or urticaria, or for recurrence of any Grade 2 symptoms, permanently discontinue POLIVY.
Otherwise, upon complete resolution of symptoms, infusion may be resumed at 50% of the rate achieved prior to interruption. In the absence of infusion-related symptoms, the rate of infusion may be escalated in increments of 50 mg/hour every 30 minutes.
For the next cycle, infuse POLIVY over 90 minutes. If no infusion-related reaction occurs, subsequent infusions may be administered over 30 minutes. Administer premedication for all cycles. |
| Grade 4 IRR | Stop POLIVY infusion immediately.
Give supportive treatment.
Permanently discontinue POLIVY. |
The efficacy and safety of POLIVY was evaluated in an international, randomised, double-blind, placebo-controlled, phase III trial in 879 patients with previously untreated DLBCL2
ADC=antibody-drug conjugate; ANC=absolute neutrophil count; DLBCL=diffuse large B-cell lymphoma; IRR=infusion-related reactions; IV=intravenous; R-CHP=rituximab + cyclophosphamide, doxorubicin, prednisone; mAb=monoclonal antibody; MMAE=monomethyl auristatin E; PN=peripheral neuropathy; R/R=relapsed or refractory.
References:
This medicinal product is subject to additional monitoring in EU countries.
This will allow quick identification of new safety information.
Healthcare professionals are asked to report any suspected adverse reactions.
© 2025 F. Hoffmann-La Roche Ltd. January 2025 M-XX-00010577
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