Polatuzumab vedotin

Generic Name: Polatuzumab vedotin

Brand Names: Polivy

Drug Type: Biotech

CAS Number: 1313206-42-6

Unique Ingredient Identifier: KG6VO684Z6

Background: Polatuzumab vedotin is a CD79b-directed antibody-drug conjugate that delivers monomethyl auristatin E (MMAE), an anti-mitotic agent, to cancer cells. The drug consists of three components - a humanized immunoglobulin G1 (IgG1) monoclonal antibody specific for human CD79b (polatuzumab), MMAE, and protease-cleavable linker called maleimidocaproyl-valine-citrulline-p-aminobenzyloxycarbonyl (mc-vc-PAB) that covalently attaches MMAE to polatuzumab.

Polatuzumab vedotin was granted accelerated FDA approval on June 10, 2019 and was approved by Health Canada on July 9, 2020.

Indication: Polatuzumab vedotin is used in combination with bendamustine and rituximab to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, after at least two prior therapies. In Canada, this indication is approved for patients who are not eligible for autologous stem cell transplant and have received at least one prior therapy.

Polatuzumab vedotin is also used in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) to treat adult patients with previously untreated large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), high-grade B-cell lymphoma, Epstein-Barr virus-positive (EBV+) DLBCL NOS, and T-cell/histiocyte rich LBCL.

Associated Conditions: Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Epstein-Barr Virus-positive Diffuse Large B-cell Lymphoma, High-grade B Cell Lymphoma (HGBCL), Large B Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, T-Cell/Histiocyte-Rich Large B-Cell Lymphoma, Relapsed Diffuse large B-cell lymphoma NOS

Clinical Trials

A Trial of Polatuzumab Vedotin, Obinutuzumab and Glofitamab As a Peri-CAR-T Cell Treatment Strategy in Large B-cell Lymphoma

Phase 2

Recruiting

Conditions: Large B-cell Lymphoma

Interventions: Drug: Glofitamab
Drug: Polatuzumab vedotin
Drug: Obinutuzumab

First Posted Date: 2023-10-10

Last Posted Date: 2024-12-24

Lead Sponsor: University College, London

Target Recruit Count: 99

Registration Number: NCT06071871

Locations: 🇬🇧
Kings College Hospital NHS Foundation Trust, London, United Kingdom
🇬🇧
University College London Hospitals NHS Foundation Trust, London, United Kingdom
🇬🇧
The Christie NHS Foundation Trust, Manchester, United Kingdom

and more 2 locations

An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma

Phase 3

Recruiting

Conditions: Large B-Cell Lymphoma

Interventions: Drug: Glofitamab
Drug: Polatuzumab vedotin
Drug: Rituximab
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Prednisone

First Posted Date: 2023-09-21

Last Posted Date: 2025-05-09

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 1130

Registration Number: NCT06047080

Locations: 🇺🇸
Alaska Oncology & Hematology, LLC, Anchorage, Alaska, United States
🇺🇸
Kaiser Permanente - Anaheim (E. La Palma), Anaheim, California, United States
🇺🇸
University of California, San Francisco-Fresno, Clovis, California, United States

and more 265 locations

A Ph2 Study of Glofitamab Alone or With Polatuzumab Vedotin, Pirtobrutinib, or Atezolizumab in Richter's Transformation

Phase 2

Recruiting

Conditions: Chronic Lymphocytic Leukemia
Richter's Transformation

Interventions: Drug: Glofitamab
Drug: Obinutuzumab
Drug: Atezolizumab
Drug: Tocilizumab
Drug: Polatuzumab Vedotin
Drug: Pirtobrutinib

First Posted Date: 2023-09-21

Last Posted Date: 2025-05-22

Lead Sponsor: Christine Ryan

Target Recruit Count: 70

Registration Number: NCT06043674

Locations: 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

and more 1 locations

Polatuzumab Vedotin (Pola) Plus Rituximab (R) in Patients With Post-transplant Lymphoproliferative Disorder (PTLD)

Phase 1

Recruiting

Conditions: Post-transplant Lymphoproliferative Disorder

Interventions: Drug: Polatuzumab vedotin
Drug: Rituximab
Drug: CHP

First Posted Date: 2023-09-15

Last Posted Date: 2025-01-14

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 12

Registration Number: NCT06040320

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Phase 1

Recruiting

Conditions: High Grade B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma

Interventions: Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Lenalidomide
Biological: Mosunetuzumab
Drug: Polatuzumab Vedotin
Procedure: Positron Emission Tomography

First Posted Date: 2023-08-29

Last Posted Date: 2025-03-11

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 30

Registration Number: NCT06015880

Locations: 🇺🇸
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
🇺🇸
City of Hope Comprehensive Cancer Center LAO, Duarte, California, United States
🇺🇸
City of Hope Comprehensive Cancer Center, Duarte, California, United States

and more 5 locations

A Study to Evaluate the Effectiveness and Safety of Polatuzumab in Real World Clinical Practice Among Adult Chinese Participants With Diffuse Large B-Cell Lymphoma

Recruiting

Conditions: Diffuse Large B-Cell Lymphoma

Interventions: Drug: Polatuzumab Vedotin

First Posted Date: 2023-07-20

Last Posted Date: 2025-05-04

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 1000

Registration Number: NCT05954910

Locations: 🇨🇳
Xinjiang Medical University Cancer Hospital, Urumqi City, China
🇨🇳
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan City, China
🇨🇳
Wuxi People's Hospital, Wuxi, China

and more 26 locations

Rituximab in Combination With Glofitamab and Polatuzumab Vedotin in Patients With Previously Untreated Aggressive B-cell Lymphoma Ineligible for R-CHOP

Phase 2

Active, not recruiting

Conditions: Lymphoma, Large B-Cell, Diffuse

Interventions: Drug: Glofitamab
Drug: Rituximab
Drug: Obinutuzumab
Drug: Polatuzumab vedotin

First Posted Date: 2023-04-04

Last Posted Date: 2025-05-02

Lead Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Target Recruit Count: 125

Registration Number: NCT05798156

Locations: 🇦🇹
Hanusch Krankenhaus, Wien, Austria
🇦🇹
Kepler Universitätsklinikum, Linz, Austria
🇦🇹
Ordensklinikum Linz - Barmherzige Schwestern, Linz, Austria

and more 27 locations

Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

Phase 2

Recruiting

Conditions: Primary Mediastinal (Thymic) Large B-Cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma
Transformed Marg Zone Lymph to Diff Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma
Grade 3b Follicular Lymphoma
Transformed Follic Lymph to Diff Large B-Cell Lymphoma

Interventions: Biological: Axicabtagene Ciloleucel
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Cyclophosphamide
Biological: Mosunetuzumab
Other: Patient Observation
Drug: Fludarabine
Drug: Polatuzumab Vedotin
Biological: Lisocabtagene Maraleucel
Procedure: Positron Emission Tomography
Biological: Tisagenlecleucel

First Posted Date: 2022-12-01

Last Posted Date: 2024-12-20

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 396

Registration Number: NCT05633615

Locations: 🇺🇸
Highlands Oncology Group - Fayetteville, Fayetteville, Arkansas, United States
🇺🇸
Highlands Oncology Group - Rogers, Rogers, Arkansas, United States
🇺🇸
Highlands Oncology Group, Springdale, Arkansas, United States

and more 73 locations