Drug updated on 9/4/2024
Dosage Form | Injection (intravenous; 30 mg/vial, 140 mg/vial) |
Drug Class | CD79b-directed antibodies and microtubule inhibitor conjugates |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients 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.
- Indicated in combination with bendamustine and a rituximab product for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, after at least two prior therapies.
Latest News
Summary
- Polivy (polatuzumab vedotin-piiq) is indicated in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for treating adult patients with 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. It is also indicated in combination with bendamustine and a rituximab product for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, after at least two prior therapies.
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- Health-Related Quality of Life (HRQOL) and Utility Values in R/R LBCL: Utility values for novel therapies, including polatuzumab vedotin, were 0.83 for progression-free survival and ranged from 0.39 to 0.71 for disease progression. On-treatment utility values for CAR T-cell therapies were 0.50 to 0.74, and for salvage chemotherapy, 0.63 to 0.67.
- Efficacy of Salvage Treatments in R/R DLBCL: In ASCT-eligible patients, 1-year progression-free survival (PFS) rates were 0.40 (95% CI: 0.15 to 0.65) for CAR T-cell therapy and 0.34 (95% CI: 0.30 to 0.37) for chemotherapy followed by ASCT. In ASCT-ineligible patients, 1-year PFS rates were 0.40 (95% CI: 0.35 to 0.46) for CAR T-cell therapy and 0.47 (95% CI: 0.37 to 0.57) for the Tafasitamab group.
- Clinical Evidence on Treatments for Transplant-Ineligible R/R DLBCL: The review highlighted the limited availability of randomized controlled trials (RCTs) for polatuzumab vedotin combined with bendamustine and rituximab, with only two RCTs showing positive outcomes. The scarcity of data limited the ability to establish comparative efficacy.
- There is no safety information available in the reviewed studies.
- The evidence source highlights two specific population subgroups: ASCT-eligible and ASCT-ineligible patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), with different efficacy outcomes observed between these groups, particularly in 1-year progression-free survival (PFS) rates. There is no additional population or subgroup information available beyond this differentiation.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Polivy (polatuzumab vedotin-piiq) Prescribing Information. | 2023 | Genentech, Inc., South San Francisco, CA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of lymphoma. | 2020 | Journal for ImmunoTherapy of Cancer |