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
Parsaclisib Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma
- Conditions
- Ann Arbor Stage II Diffuse Large B-Cell LymphomaAnn Arbor Stage II Marginal Zone LymphomaDiffuse Large B-Cell LymphomaHigh Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 RearrangementsAnn Arbor Stage II Follicular LymphomaAnn Arbor Stage IV Diffuse Large B-Cell LymphomaAnn Arbor Stage IV Follicular LymphomaAnn Arbor Stage IV Marginal Zone LymphomaAnn Arbor Stage III Diffuse Large B-Cell LymphomaAnn Arbor Stage III Follicular Lymphoma
- Interventions
- First Posted Date
- 2020-03-27
- Last Posted Date
- 2025-02-26
- Lead Sponsor
- Mayo Clinic
- Target Recruit Count
- 50
- Registration Number
- NCT04323956
- Locations
- 🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
🇺🇸Mayo Clinic in Florida, Jacksonville, Florida, United States
🇺🇸Mayo Clinic in Rochester, Rochester, Minnesota, United States
A Study to Evaluate the Efficacy and Safety of Polatuzumab Vedotin in Combination With Bendamustine and Rituximab Compared With Bendamustine and Rituximab Alone in Chinese Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL).
- Conditions
- Diffuse, Large B-Cell, Lymphoma
- Interventions
- First Posted Date
- 2020-01-22
- Last Posted Date
- 2023-03-03
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 42
- Registration Number
- NCT04236141
- Locations
- 🇨🇳
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University), Nanjing City, China
🇨🇳Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan City, China
🇨🇳West China Hospital, Sichuan University, Chengdu, China
Polatuzumab Vedotin and Combination Chemotherapy for the Treatment of Untreated Aggressive Large B-cell Lymphoma
- Conditions
- Aggressive Non-Hodgkin LymphomaALK-Positive Large B-Cell LymphomaDiffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedEBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedHigh Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 RearrangementsHigh Grade B-Cell Lymphoma, Not Otherwise SpecifiedPrimary Mediastinal Large B-Cell LymphomaT-Cell/Histiocyte-Rich Large B-Cell LymphomaGray-Zone Lymphoma
- Interventions
- Procedure: Multigated Acquisition ScanProcedure: EchocardiographyProcedure: FDG-Positron Emission TomographyProcedure: Computed TomographyProcedure: Bone Marrow BiopsyProcedure: Biospecimen CollectionProcedure: Bone Marrow Aspiration
- First Posted Date
- 2020-01-18
- Last Posted Date
- 2025-04-11
- Lead Sponsor
- University of Washington
- Target Recruit Count
- 56
- Registration Number
- NCT04231877
- Locations
- 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States
A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
- Conditions
- Diffuse Large B-Cell Lymphoma
- Interventions
- First Posted Date
- 2019-12-02
- Last Posted Date
- 2025-01-24
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 270
- Registration Number
- NCT04182204
- Locations
- 🇹🇷
Istanbul Uni Istanbul Medical Faculty, Istanbul, Turkey
🇺🇸MSKCC at Basking Ridge, Basking Ridge, New Jersey, United States
🇮🇹USL 4 di Prato - Nuovo Ospeale di Prato, Prato, Toscana, Italy
Trial of Mosunetuzumab (BTCT4465A) as Consolidation Therapy in Participants With Diffuse Large B-Cell Lymphoma Following First-Line Immunochemotherapy and as Monotherapy or in Combination With Polatuzumab Vedotin in Elderly/Unfit Participants With Previously Untreated Diffuse Large B-Cell Lymphoma
- Conditions
- Diffuse Large B-cell Lymphoma
- Interventions
- First Posted Date
- 2018-09-19
- Last Posted Date
- 2025-04-03
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 188
- Registration Number
- NCT03677154
- Locations
- 🇮🇱
Rambam Medical Center, Haifa, Israel
🇮🇱Carmel medical center, Haifa, Israel
🇰🇷Severance Hospital, Yonsei University, Seoul, Korea, Republic of
A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma
- Conditions
- B-cell Non-Hodgkin Lymphoma
- Interventions
- First Posted Date
- 2018-09-19
- Last Posted Date
- 2024-12-18
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 117
- Registration Number
- NCT03677141
- Locations
- 🇺🇸
University of Alabama Birmingham, Birmingham, Alabama, United States
🇺🇸Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
🇺🇸University of California; Moores Cancer Center, La Jolla, California, United States
A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma
- Conditions
- B-cell Non-Hodgkin Lymphoma
- Interventions
- First Posted Date
- 2018-09-14
- Last Posted Date
- 2024-11-28
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 422
- Registration Number
- NCT03671018
- Locations
- 🇺🇸
University of Pittsburgh - Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
🇺🇸University of Miami Miller School of Medicine, Miami, Florida, United States
🇺🇸University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States
An Open-Label Phase lB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
- Conditions
- Non-Hodgkins Lymphoma
- Interventions
- First Posted Date
- 2018-05-23
- Last Posted Date
- 2025-04-11
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 211
- Registration Number
- NCT03533283
- Locations
- 🇩🇰
Aarhus Universitetshospital Skejby, Aarhus N, Denmark
🇩🇰Rigshospitalet, København Ø, Denmark
🇩🇰Odense Universitetshospital, Odense C, Denmark
A Study of Glofitamab in Combination With Rituximab or Obinutuzumab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (CHP) in Participants With Non-Hodgkin Lymphomas or With DLBCL
- Conditions
- B-Cell LymphomaNon-Hodgkin Lymphoma
- Interventions
- First Posted Date
- 2018-03-16
- Last Posted Date
- 2025-01-17
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 111
- Registration Number
- NCT03467373
- Locations
- 🇩🇰
Rigshospitalet, København Ø, Denmark
🇫🇷Hopital Claude Huriez, Lille, France
🇫🇷Hopital Hotel Dieu Et Hme, Nantes, France
A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma
- Conditions
- Diffuse Large B-Cell Lymphoma
- Interventions
- First Posted Date
- 2017-09-07
- Last Posted Date
- 2025-03-27
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 1000
- Registration Number
- NCT03274492
- Locations
- 🇷🇺
Leningrad Regional Clinical Hospital, St Petersburg, Sankt Petersburg, Russian Federation
🇪🇸Complejo Hospitalario de Navarra, Pamplona, Navarra, Spain
🇪🇸Hospital Universitari Vall d'Hebron, Barcelona, Spain
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.