Drugs / Polatuzumab
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04739813 | Jul 2021 → May 2026 overdue | Burkitt lymphoma, diffuse large B-cell lymphoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT06765317 | Jan 2025 → Jan 2028 expected | high grade B-cell lymphoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05800366 | Apr 2023 → Sep 2026 overdue | diffuse large B-cell lymphoma | Jennifer Crombie, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT05260957 | Dec 2022 → Dec 2026 expected | non-Hodgkin lymphoma | Lazaros Lekakis | Recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT07371923 Background | Nov 2025 → Feb 2028 expected | diffuse large B-cell lymphoma | Beijing Tongren Hospital | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 21
| Date | Issuer | Release |
|---|---|---|
| 2026-06-17 | Genentech, Inc. | Regulatory FDA Accepts Supplemental Biologics License Application for Genentech’s Lunsumio and Polivy Combination for People With Relapsed or Refractory Large B-Cell Lymphoma gene.com ↗
FDA Accepts Supplemental Biologics License Application for Genentech’s Lunsumio and Polivy Combination for People With Relapsed or Refractory Large B-Cell Lymphoma |
| 2025-12-08 | Genentech, Inc. | Results Genentech Presents Lunsumio Data Showing Potential Across Earlier Treatment Lines in Indolent and Aggressive Lymphomas gene.com ↗
Long term follow-up data from the Phase Ib/II GO40516 study demonstrated sustained improvements in patients treated with investigational SC Lunsumio in combination with Polivy compared to those treated with Rituxan® (rituximab) and Polivy in people with 2L+ LBCL. |
| 2025-11-03 | Genentech, Inc. | Results Genentech to Present New Data From Its Broad and Innovative Hematology Portfolio at ASH 2025 gene.com ↗
Long-term follow-up data from the Phase Ib/II GO40516 study demonstrate sustained improvements in objective response rate (ORR) and progression-free survival with this combination in people with 2L+ large B-cell lymphoma (LBCL). |
| 2025-06-20 | Genentech, Inc. | Results Genentech’s Lunsumio and Polivy Combination Significantly Prolongs Remission for People With Relapsed or Refractory Large B-Cell Lymphoma gene.com ↗
Genentech’s Lunsumio and Polivy Combination Significantly Prolongs Remission for People With Relapsed or Refractory Large B-Cell Lymphoma |
| 2024-12-09 | Genentech, Inc. | Results New and Updated Data for Genentech’s Fixed-Duration Columvi and Lunsumio at ASH 2024 Reinforce Their Potential to Improve Outcomes for People With Lymphoma gene.com ↗ |
| 2024-12-08 | Genentech, Inc. | Results Five-Year Results Confirm Genentech’s Polivy Combination Therapy as New Standard of Care for Previously Untreated Aggressive Lymphoma gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today data from a five-year follow-up of the pivotal Phase III POLARIX study evaluating Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) in people with untreated diffuse large B-cell lymphoma (DLBCL). |
| 2024-11-05 | Genentech, Inc. | Results Genentech to Present New and Encouraging Long-term Follow-up Data Across Broad Hematology Portfolio at ASH 2024 gene.com ↗
Five-year data from the Phase III POLARIX study (abstract #469) reinforce the potential of Polivy in combination with Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) to provide durable and lasting remissions |
| 2023-12-10 | Genentech, Inc. | Results New Data for Genentech’s Columvi and Lunsumio Presented at ASH 2023 Support Continued Benefit for People With Lymphoma gene.com ↗
Results showed that at 24 months median follow-up, the median PFS was 11.4 months (95% CI: 6.2–18.7), and median OS was 23.3 months (95% CI: 14.8–NE), highlighting the combination’s potential in R/R LBCL. |
| 2023-04-19 | Genentech, Inc. | Regulatory FDA Approves Genentech's Polivy in Combination With R-CHP for People With Certain Types of Previously Untreated Diffuse Large B-Cell Lymphoma gene.com ↗
Polivy combination is the first FDA-approved therapy in nearly 20 years for the first-line treatment of diffuse large B-cell lymphoma, an aggressive disease and the most common form of non-Hodgkin’s lymphoma in the U.S. |
| 2023-03-09 | Genentech, Inc. | Regulatory FDA Advisory Committee Votes in Favor of the Clinical Benefit of Genentech's Polivy Combination for People With Previously Untreated Diffuse Large B-Cell Lymphoma gene.com ↗
U.S. FDA’s Oncologic Drugs Advisory Committee voted 11 to 2 in favor of the clinical benefit of the Phase III POLARIX study of Polivy in combination with R-CHP for people with previously untreated diffuse large B-cell lymphoma |
| 2022-12-11 | Genentech, Inc. | Results Genentech Presents New and Updated Data for Polivy in Previously Untreated Diffuse Large B-Cell Lymphoma at ASH 2022 gene.com ↗
Updated data from the Phase III POLARIX study continue to demonstrate a statistically significant reduction in the risk of disease worsening or death for people with previously untreated diffuse large B-cell lymphoma (DLBCL) |
| 2022-11-03 | Genentech, Inc. | Results Genentech to Present Data at ASH 2022 Showcasing Strength of Hematology Portfolio and Expanding Into New Areas to Address More Patient Needs gene.com ↗
New and updated data support use of Polivy in diffuse large B-cell lymphoma, including its potential as a treatment option for previously untreated patients |
| 2022-08-15 | Genentech, Inc. | Regulatory FDA Accepts Supplemental Biologics License Application for Genentech's Polivy Combination for People With Previously Untreated Diffuse Large B-Cell Lymphoma gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people with previously untreated diffuse large B-cell lymphoma (DLBCL). |
| 2021-12-14 | Genentech, Inc. | Results Genentech’s Polivy Combination Reduced the Risk of Disease Worsening or Death by 27% in People With Previously Untreated Aggressive Form of Lymphoma gene.com ↗
Genentech’s Polivy Combination Reduced the Risk of Disease Worsening or Death by 27% in People With Previously Untreated Aggressive Form of Lymphoma |
| 2021-12-11 | Genentech, Inc. | Results Genentech Presents Pivotal Data at ASH 2021 for Novel Cancer Immunotherapy Mosunetuzumab gene.com ↗
CRS occurred in 18% of patients, and all events occurred in Cycle 1 and were Grade 1-2. |
| 2021-11-23 | Genentech, Inc. | Results Genentech to Present New Pivotal Data at ASH 2021 From Broad and Comprehensive Portfolio, Challenging Treatment Standards for People With Blood Disorders gene.com ↗
Phase III POLARIX trial showed Polivy plus R-CHP was the first treatment in two decades to significantly improve outcomes in newly diagnosed diffuse large B-cell lymphoma versus the standard of care |
| 2021-08-08 | Genentech, Inc. | Results Phase III Study Shows Genentech's Polivy Plus R-CHP is the First Regimen in 20 Years to Significantly Improve Outcomes in Previously Untreated Aggressive Form of Lymphoma Compared to Standard of Care gene.com ↗
Phase III Study Shows Genentech's Polivy Plus R-CHP is the First Regimen in 20 Years to Significantly Improve Outcomes in Previously Untreated Aggressive Form of Lymphoma Compared to Standard of Care |
| 2021-06-04 | Genentech, Inc. | Results Genentech Presents Latest Advances With Immunotherapies in Non-Hodgkin’s Lymphoma gene.com ↗
Data for investigational CD20xCD3 bispecific antibodies and new combination regimens with Polivy showed enhanced clinical benefits for people with non-Hodgkin’s lymphoma in early studies |
| 2019-06-10 | Genentech, Inc. | Regulatory FDA Grants Genentech’s Polivy Accelerated Approval for People With Previously Treated Aggressive Lymphoma gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Polivy™ (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan® (rituximab) (BR) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least two prior therapies. |
| 2019-02-18 | Genentech, Inc. | Regulatory FDA Grants Priority Review to Genentech’s Polatuzumab Vedotin in Previously Treated Aggressive Lymphoma gene.com ↗
FDA Grants Priority Review to Genentech’s Polatuzumab Vedotin in Previously Treated Aggressive Lymphoma |
| 2017-12-10 | Genentech, Inc. | Results Phase II Data Showed Genentech’s Investigational Polatuzumab Vedotin Plus Bendamustine and Rituxan (BR) Increased Complete Response Rates Compared to BR Alone in Previously Treated Aggressive Lymphoma gene.com ↗
Phase II Data Showed Genentech’s Investigational Polatuzumab Vedotin Plus Bendamustine and Rituxan (BR) Increased Complete Response Rates Compared to BR Alone in Previously Treated Aggressive Lymphoma |
All press releases naming this drug 21 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Polatuzumab | “zanubrutinib combined with Pola-R-CHP regimen: zanubrutinib 160mg bid d1-d21/C1-C6; polatuzumab 1.8mg/kg d1/C1-C6; rituximab 375mg/㎡, iv, d1/C1-C6; cyclophosphamide 750mg/㎡,...” NCT07371923 ↗ |
| Modality | Monoclonal antibody | “an antibody drug conjugate (ADC) that contains a humanized IgG1 anti-human CD79b monoclonal antibody, via IV infusion” NCT05800366 ↗ |
| Route | Intravenous | “administered intravenously” NCT04739813 ↗ |
| Target | CD79B | “anti-mitotic antibody-drug conjugate targeting CD79b, polatuzumab” NCT04739813 ↗ |