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About POLIVY

POLIVY is an antibody-drug conjugate (ADC) targeted to CD79b, which is ubiquitously expressed on the surface of B-cell lymphomas1

Watch Expert Perspectives

Specialist views covering a range of POLARIX trial topics

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Dr Hervé Tilly,
University of Rouen, France

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Prof. Christopher Flowers,
MD, Anderson Cancer Center, University of Texas

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Dr Franck Morschhauser,
MD, PhD Professor of Hematology,
University of Lille

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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 

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Mechanism of Action

The polatuzumab vedotin molecule consists of MMAE covalently attached to a humanised immunoglobulin G1 monoclonal antibody via a cleavable linker.1

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Dosing and administration:

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:

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1.8 mg/kg  

recommended dose

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Intravenous infusion 

method of administration 

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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

Recommended dosing schedule for POLIVY1

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Additional dosing information

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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

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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

Dose modifications

  • POLIVY dose modifications for peripheral neuropathy (PN)
    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.

    No filter results

    *R-CHP may continue to be administered.

  • POLIVY, chemotherapy and rituximab dose modifications to manage myelosuppression
    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/m2 to 70 mg/m2 or 70 mg/m2

    to 50 mg/m2 

    • If a bendamustine dose reduction to 50 mg/m2 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/m2 to 70 mg/m2 or 70 mg/m2

    to 50 mg/m2 

    • If a bendamustine dose reduction to 50 mg/m2 has

    already occurred, discontinue all treatment

    No filter results

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

  • POLIVY dose modifications for infusion-related reactions (IRRs)
    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.

    No filter results

POLARIX® study

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

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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:

  1. POLIVY. Summary of Product Characteristics.
  2. Tilly H, et al. N Engl J Med. 2022;386:351-63.