P=N/A, N=100, Active, not recruiting, IRCCS Azienda Ospedaliero-Universitaria di Bologna

While 12-month PFS failed to reach statistical significance, subgroup analyses favor Pola-R-CHP. Further research with a wider population, longer follow-up, and screening of advantageous groups are warranted.

P2, N=125, Recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Active, not recruiting --> Recruiting | N=80 --> 125 | Trial primary completion date: Sep 2027 --> Apr 2025

P2, N=39, Recruiting, University of Rochester | Trial completion date: Jul 2024 --> Jul 2026 | Trial primary completion date: Jul 2024 --> Jul 2026

P2, N=42, Active, not recruiting, University of Washington | Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Mar 2025 | Trial primary completion date: Dec 2025 --> Mar 2025

P2, N=80, Not yet recruiting, Navy General Hospital, Beijing

P2, N=80, Not yet recruiting, Navy General Hospital, Beijing

Her initial treatment comprised chemo-free therapy and radiotherapy, followed by progression. In the second-line treatment, a Pola-based regimen was applied, and the patient achieved a complete response, suggesting that this regimen may be a therapeutic option for patients with DLBCL involving the central nervous system.

P=N/A, N=1000, Recruiting, Hoffmann-La Roche | Trial completion date: Sep 2026 --> Dec 2026 | Trial primary completion date: Sep 2026 --> Dec 2026

P3, N=1000, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Jul 2024 --> Jul 2026 | Trial primary completion date: Jul 2024 --> Jul 2026

In a single center real world retrospective analysis of R/R LBCL patients with available genomic data, polatuzumab based therapy may be less effective in patients with HGBL-NOS or MYC/BCL2 histology and MYC rearrangements, but not in patients with GCB COO LBCL without these features. Routine performance of more comprehensive pathologic analysis of tumors may inform the use of polatuzumab based therapy in patients with LBCL.

P3, N=222, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting | Trial completion date: Nov 2027 --> Feb 2027 | Trial primary completion date: May 2025 --> Feb 2025

P2; N=31; Not yet recruiting; Sponsor:Medical College of Wisconsin

P2, N=3, Terminated, Academic and Community Cancer Research United | N=63 --> 3 | Trial completion date: Apr 2029 --> Mar 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Apr 2027 --> Mar 2024; Trial closed due to low accrual rate

P1, N=68, Recruiting, University of Washington | Suspended --> Recruiting

See related article by Corcoran et al., p. 1653 (6) See related article by Meriranta et al. (7).

P2, N=41, Active, not recruiting, City of Hope Medical Center | Trial completion date: Mar 2024 --> Dec 2024

P2, N=36, Recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University

P2, N=41, Recruiting, City of Hope Medical Center | Not yet recruiting --> Recruiting | Trial completion date: Mar 2027 --> Mar 2028 | Trial primary completion date: Mar 2027 --> Mar 2028

P1, N=68, Suspended, University of Washington | N=50 --> 68

P3, N=100, Recruiting, Ruijin Hospital | Not yet recruiting --> Recruiting

P3, N=100, Not yet recruiting, Ruijin Hospital

P2, N=80, Active, not recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Recruiting --> Active, not recruiting

P=N/A, N=47, Not yet recruiting, Beijing Hospital; Beijing Hospital

P2, N=99, Recruiting, University College, London | Not yet recruiting --> Recruiting | Initiation date: Apr 2024 --> Jul 2024 | Trial primary completion date: Jan 2027 --> Jul 2027

P1, N=50, Terminated, Hoffmann-La Roche | Completed --> Terminated; Decision to discontinue the study based on broader development and strategic prioritisation. The Sponsor concludes there is no benefit-risk impact on the BO42203 study.

The median time to AEs occurrence following polatuzumab vedotin initiation was 18.5 (5∼57.75) days, with 95% of AEs occurred within 162 days. This study identified various AEs associated with polatuzumab vedotin, offering critical insights for clinical monitoring and risk identification in patients receiving polatuzumab vedotin therapy.

P2, N=20, Enrolling by invitation, The First Affiliated Hospital of Soochow University

P2, N=41, Not yet recruiting, City of Hope Medical Center

P2, N=152, Not yet recruiting, Ruijin Hospital

P1, N=30, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Jun 2026 | Trial primary completion date: Dec 2025 --> Jun 2026

P1/2, N=188, Active, not recruiting, Hoffmann-La Roche | Trial primary completion date: Aug 2023 --> Aug 2025

The molecule has recently been under the spotlights for the promising results of the frontline combination with rituximab cyclophosphamide doxorubicin and prednisone (R-CHP) in the phase III POLARIX study, demonstrating improved progression-free survival over standard R-CHOP. A remarkable improvement in terms of complete response rate and overall survival with polatuzumab vedotin has also been achieved by combining polatuzumab with rituximab and bendamustine (pola-BR) over the standard BR for relapsed/refractory patients. Based on the results of these studies, health authorities in several countries granted approval for polatuzumab vedotin both for patients with previously untreated and for relapsed/refractory DLBCL. In this review, we summarize the data of major studies recently concluded with polatuzumab vedotin, and we provide an overview of the ongoing combination trials for frontline and relapsed/refractory DLBCL, outlining reported toxicities.

P1, N=50, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed | Trial completion date: Feb 2025 --> May 2024

P2, N=16, Recruiting, Medical University of Vienna | Not yet recruiting --> Recruiting

P1, N=30, Recruiting, National Cancer Institute (NCI) | Initiation date: Sep 2024 --> May 2024

P2, N=0, Withdrawn, Fondazione Italiana Linfomi - ETS | N=150 --> 0 | Not yet recruiting --> Withdrawn

We reveal how KLHL6 targets CD79B for degradation in normal and malignant germinal center B cells, thereby determining expression of the surface BCR complex. Our findings suggest precision medicine strategies to optimize Pola-V as a lymphoma therapeutic.

P1, N=50, Suspended, University of Washington | Recruiting --> Suspended

The phase III POLARIX study (NCT03274492) evaluated polatuzumab vedotin in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) as first-line treatment of diffuse large B-cell lymphoma (DLBCL). An increase of <50% in acMMAE/unconjugated MMAE exposure did not lead to a clinically meaningful increase in adverse events of special interest. ER data and the benefit-risk profile support the use of polatuzumab vedotin 1.8 mg/kg once every 3 weeks with R-CHP for six cycles in patients with previously untreated DLBCL.

P3, N=270, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Dec 2025 --> Mar 2025

P2, N=99, Not yet recruiting, University College, London | Trial completion date: Jan 2028 --> Jul 2028 | Initiation date: Jan 2024 --> Apr 2024 | Trial primary completion date: Jan 2028 --> Jan 2027