Polivy Generic Name & Formulations
Mechanism of Action
Polatuzumab vedotin-piiq is a CD79b-directed antibody-drug conjugate with activity against dividing B cells. The small molecule, MMAE, is an anti-mitotic agent covalently attached to the antibody via a cleavable linker. The monoclonal antibody binds to CD79b, a B-cell specific surface protein, which is a component of the B-cell receptor. Upon binding CD79b, polatuzumab vedotin-piiq is internalized, and the linker is cleaved by lysosomal proteases to enable intracellular delivery of MMAE. MMAE binds to microtubules and kills dividing cells by inhibiting cell division and inducing apoptosis.
In combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adults who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index score of 2 or greater. In combination with bendamustine and a rituximab product for the treatment of relapsed or refractory DLBCL, NOS, after at least 2 prior therapies.
Polivy Dosage and Administration
Premedicate with antihistamine and antipyretic ≥30–60mins prior to dosing. Give by IV infusion. Initially 1.8mg/kg over 90mins every 21 days for 6 cycles; if tolerated, may give subsequent doses over 30mins. Previously untreated DLBCL, NOS, or HGBL: administer with R-CHP in any order on Day 1 after administering prednisone on Days 1–5 of each cycle. Relapsed or refractory DLBCL: administer with bendamustine and a rituximab product in any order on Day 1 of each cycle. Dose modifications for adverse reactions: see full labeling.
Polivy Boxed Warnings
Monitor for peripheral neuropathy; interrupt, reduce dose, or discontinue based on severity if occurs. Monitor CBCs during treatment; interrupt, reduce dose, or discontinue if cytopenias occur. For neutropenia: administer prophylactic G-CSF in those on Polivy plus R-CHP; consider prophylactic G-CSF in those on Polivy plus bendamustine/rituximab product. Monitor closely for tumor lysis syndrome, serious/fatal infections (eg, sepsis, pneumonia, herpes, CMV); give prophylaxis for Pneumocystis jiroveci pneumonia and herpes virus. Monitor closely for infusion-related reactions; interrupt and treat if occurs; permanently discontinue based on severity. Monitor for progressive multifocal leukoencephalopathy (PML); withhold if suspected and permanently discontinue if confirmed. Risk of hepatotoxicity; monitor LFTs. Moderate to severe hepatic impairment: avoid. Embryo-fetal toxicity. Pregnancy: avoid; exclude status prior to initiation. Advise use of effective contraception during and for ≥3 months (females) and ≥5 months (males w. female partners) after last dose. Nursing mothers: not recommended (during and for ≥2 months after last dose).
The antibody-conjugated monomethyl auristatin E (acMMAE) central volume of distribution is 3.15 L.
MMAE plasma protein binding is 71–77%, and the blood-to-plasma ratio is 0.79–0.98, in vitro.
Median acMMAE half-life: 12.2 days (4.5–36.7 days). Median unconjugated MMAE half-life: 3.74 days (1.58–10.1 days).
Clearance: 0.9 L/day (in patients with B-cell malignancies).
Polivy Adverse Reactions
Peripheral neuropathy, nausea, fatigue, diarrhea, constipation, alopecia, mucositis, thrombocytopenia, pyrexia, decreased appetite, pneumonia, Grade 3/4 lab abnormalities (lymphopenia, neutropenia, hyperuricemia, anemia); infusion-related reactions, infection, tumor lysis syndrome, PML, hepatotoxicity.
Polivy Clinical Trials
Polivy Patient Counseling