Polatuzumab Vedotin Evidence: Trial Results and Peer-Reviewed Publications

Hipa.ai Research · Source: PubMed & ClinicalTrials.gov / AACT · Last updated:

The clinical evidence base for Polatuzumab Vedotin comprises 33 peer-reviewed publications across 15 journals, 6 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including Lymphoma, Large B-Cell, Diffuse, Lymphoma, Lymphoma, B-Cell, and Lymphoma, Non-Hodgkin. Most recent publication: Diffuse Large B-Cell Lymphoma Presenting in a Background of Rosai-Dorfman Disease., Case Rep Hematol, 2026.

Top peer-reviewed publications

Curated set of pivotal-trial result papers and recent publications in high-tier journals.

  1. Diffuse Large B-Cell Lymphoma Presenting in a Background of Rosai-Dorfman Disease.
    Wu C, Meyer A, Tun AM, et al. · Case Rep Hematol · 2026
    PubMed: PMID 42158929 · NCT04884035 · Lymphoma, B-Cell
  2. Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma.
    Tilly H, Morschhauser F, Sehn LH, et al. · N Engl J Med · 2022
    PubMed: PMID 34904799 · NCT03274492 (POLARIX) · Lymphoma, Large B-Cell, Diffuse
  3. Polatuzumab vedotin in combination with immunochemotherapy in patients with previously untreated diffuse large B-cell lymphoma: an open-label, non-randomised, phase 1b-2 study.
    Tilly H, Morschhauser F, Bartlett NL, et al. · Lancet Oncol · 2020
    PubMed: PMID 31101489 · NCT01992653 · Lymphoma, Non-Hodgkin
  4. Safety and activity of the anti-CD79B antibody-drug conjugate polatuzumab vedotin in relapsed or refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukaemia: a phase 1 study.
    Palanca-Wessels MC, Czuczman M, Salles G, et al. · Lancet Oncol · 2015
    PubMed: PMID 25925619 · NCT01290549 · Lymphoma, Non-Hodgkin
  5. Polatuzumab vedotin or pinatuzumab vedotin plus rituximab in patients with relapsed or refractory non-Hodgkin lymphoma: final results from a phase 2 randomised study (ROMULUS).
    Morschhauser F, Flinn IW, Advani R, et al. · Lancet Haematol · 2019
    PubMed: PMID 30935953 · NCT01691898 (ROMULUS) · Lymphoma, Large B-Cell, Diffuse
  6. Polatuzumab vedotin plus obinutuzumab and lenalidomide in patients with relapsed or refractory follicular lymphoma: a cohort of a multicentre, single-arm, phase 1b/2 study.
    Diefenbach C, Kahl BS, McMillan A, et al. · Lancet Haematol · 2022
    PubMed: PMID 34826412 · NCT02600897 · Lymphoma, Large B-Cell, Diffuse
  7. Mosunetuzumab with polatuzumab vedotin in relapsed or refractory aggressive large B cell lymphoma: a phase 1b/2 trial.
    Budde LE, Olszewski AJ, Assouline S, et al. · Nat Med · 2024
    PubMed: PMID 38072960 · NCT03671018 · Lymphoma, B-Cell
  8. Polatuzumab vedotin plus rituximab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma: a cohort of a multicentre, single-arm, phase 1b/2 study.
    Abrisqueta P, González-Barca E, Panizo C, et al. · Lancet Haematol · 2024
    PubMed: PMID 38190832 · NCT02600897 · Lymphoma, Large B-Cell, Diffuse

Primary-outcome results across pivotal trials

Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.

TrialIndicationPrimary endpointArmValue
NCT04182204
POLARGO
Lymphoma, Large B-Cell, DiffuseStage 1: Number of Participants With Adverse Events (AEs)
From treatment initiation until 90 days after the last dose of study drug or initiation of non-protocol-specified anti-lymphoma treatment (NALT) (Up to approximately 8.3 months)
Stage 1: Pola-R-GemOx14 Participants
NCT04182204
POLARGO
Lymphoma, Large B-Cell, DiffuseStage 1: Number of Participants With Peripheral Neuropathy (PN)
From treatment initiation until 90 days after the last dose of study drug or initiation of NALT (Up to approximately 8.3 months)
Stage 1: Pola-R-GemOx8 Participants
NCT04182204
POLARGO
Lymphoma, Large B-Cell, DiffuseStage 2: Overall Survival (OS)
From randomization to death (Up to approximately 34 months)
Stage 2: Pola-R-GemOx19.5 months
Stage 2: R-GemOx12.5 months
NCT04236141Lymphoma, Large B-Cell, DiffusePercentage of Participants With Complete Response (CR) at the End of Treatment (EOT) Assessment Based on Positron Emission Tomography-Computed Tomography (PET-CT) Assessed by Independent Review Committee (IRC)
Up to approximately 23 weeks
Placebo Plus Bendamustine and Rituximab14.3 percentage of participants
Polatuzumab Vedotin Plus Bendamustine and Rituximab25.0 percentage of participants
NCT05171647
SUNMO
Lymphoma, Non-HodgkinObjective Response Rate (ORR) as Determined by the Independent Review Facility (IRF), According to Lugano Response Criteria 2014 (LRC) Using Positron Emission Tomography-computed Tomography (PET-CT) or CT Scans in Interim Analysis Population (IAP)
Up to approximately 23.8 months
Arm A: Mosun-Pola69.7 percentage of participants
Arm B: R-GemOx44.1 percentage of participants
NCT05171647
SUNMO
Lymphoma, Non-HodgkinProgression-free Survival (PFS) as Determined by the IRF, According to LRC Using PET-CT or CT Scans
Up to 32 months
Arm A: Mosun-Pola11.5 months
Arm B: R-GemOx3.8 months

Publications by year

2015–2026: 33 publications.

2015
1
2019
1
2020
2
2021
3
2022
5
2023
4
2024
5
2025
8
2026
4

Publications by indication

Lymphoma, Large B-Cell, Diffuse (15)

  • PROs vs clinician-reported adverse events in a large clinical trial: findings from the phase 3 POLARIX study.
    Blood · 2026 · PMID 40997297 · NCT03274492
  • Polatuzumab Vedotin Combined With R-ICE (PolaR-ICE) as Second-Line Therapy in Diffuse Large B-Cell Lymphoma.
    Am J Hematol · 2026 · PMID 41845899 · NCT04665765
  • Remission Assessment by Circulating Tumor DNA in Large B-Cell Lymphoma.
    J Clin Oncol · 2025 · PMID 40802906 · NCT04231877
  • Five-Year Outcomes of the POLARIX Study Comparing Pola-R-CHP and R-CHOP in Patients With Diffuse Large B-Cell Lymphoma.
    J Clin Oncol · 2025 · PMID 40991874 · NCT03274492
  • Glofitamab Combined With Pola-R-CHP or R-CHOP as First Therapy in Younger Patients With High-Risk Large B-Cell Lymphoma: Results From the COALITION Study.
    J Clin Oncol · 2025 · PMID 40532125 · NCT04914741

Lymphoma (8)

  • Automated Lugano Metabolic Response Assessment in 18F-Fluorodeoxyglucose-Avid Non-Hodgkin Lymphoma With Deep Learning on 18F-Fluorodeoxyglucose-Positron Emission Tomography.
    J Clin Oncol · 2024 · PMID 38843483 · NCT02257567
  • Indirect Treatment Comparisons of Mosunetuzumab With Third- and Later-Line Treatments for Relapsed/Refractory Follicular Lymphoma.
    Clin Lymphoma Myeloma Leuk · 2024 · PMID 37981564 · NCT02257567
  • Anti-CD20-atezolizumab-polatuzumab vedotin in relapsed/refractory follicular and diffuse large B-cell lymphoma.
    J Cancer Res Clin Oncol · 2023 · PMID 35182224 · NCT02729896
  • Polatuzumab vedotin plus bendamustine and rituximab in relapsed/refractory DLBCL: survival update and new extension cohort data.
    Blood Adv · 2022 · PMID 34749395 · NCT02257567
  • Risk profiling of patients with relapsed/refractory diffuse large B-cell lymphoma by measuring circulating tumor DNA.
    Blood Adv · 2022 · PMID 35086141 · NCT02257567

Lymphoma, B-Cell (6)

  • Diffuse Large B-Cell Lymphoma Presenting in a Background of Rosai-Dorfman Disease.
    Case Rep Hematol · 2026 · PMID 42158929 · NCT04884035
  • Mosunetuzumab plus polatuzumab vedotin in relapsed/refractory MCL after BTK inhibitor therapy: a phase 2 study.
    Blood · 2026 · PMID 42013019 · NCT03671018
  • Mosunetuzumab plus Pola-CHP compared with Pola-R-CHP in previously untreated DLBCL: final results from a phase 2 study.
    Blood Adv · 2025 · PMID 39908481 · NCT03677141
  • Preclinical advances in glofitamab combinations: a new frontier for non-Hodgkin lymphoma.
    Blood · 2025 · PMID 40749164 · NCT03467373
  • Mosunetuzumab with polatuzumab vedotin in relapsed or refractory aggressive large B cell lymphoma: a phase 1b/2 trial.
    Nat Med · 2024 · PMID 38072960 · NCT03671018

Lymphoma, Non-Hodgkin (4)

  • Efficacy and Safety of Glofitamab Plus Polatuzumab Vedotin in Relapsed/Refractory Large B-Cell Lymphoma Including High-Grade B-Cell Lymphoma: Results From a Phase Ib/II Trial.
    J Clin Oncol · 2025 · PMID 41115257 · NCT03533283
  • Mosunetuzumab Plus Polatuzumab Vedotin in Transplant-Ineligible Refractory/Relapsed Large B-Cell Lymphoma: Primary Results of the Phase III SUNMO Trial.
    J Clin Oncol · 2025 · PMID 41037766 · NCT05171647
  • Polatuzumab vedotin in combination with immunochemotherapy in patients with previously untreated diffuse large B-cell lymphoma: an open-label, non-randomised, phase 1b-2 study.
    Lancet Oncol · 2020 · PMID 31101489 · NCT01992653
  • Safety and activity of the anti-CD79B antibody-drug conjugate polatuzumab vedotin in relapsed or refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukaemia: a phase 1 study.
    Lancet Oncol · 2015 · PMID 25925619 · NCT01290549

Publications by journal

Trial-results highlights

In a study of diffuse large B-cell lymphoma, NCT04236141, the percentage of participants with complete response at the end of treatment assessment was 25.0 percentage of participants in the Polatuzumab Vedotin Plus Bendamustine and Rituximab arm, and 14.3 percentage of participants in the Placebo Plus Bendamustine and Rituximab arm. Another study, NCT04182204, for diffuse large B-cell lymphoma, reported median overall survival. In Stage 2, the Pola-R-GemOx arm had a median overall survival of 19.5 months, while the R-GemOx arm had a median overall survival of 12.5 months. Regarding safety in Stage 1 of NCT04182204, the Pola-R-GemOx arm reported 14 participants with adverse events and 8 participants with peripheral neuropathy.

For non-Hodgkin lymphoma, the NCT05171647 study assessed objective response rate and progression-free survival. In the interim analysis population, the Arm A: Mosun-Pola arm showed an objective response rate in 69.7 percentage of participants, while the Arm B: R-GemOx arm showed an objective response rate in 44.1 percentage of participants. Progression-free survival in NCT05171647 was a median of 11.5 months for the Arm A: Mosun-Pola arm and 3.8 months for the Arm B: R-GemOx arm.

All values are sourced from primary registry reporting; individual papers should be consulted for clinical decisions.

All Polatuzumab Vedotin publications (33)

2026 (4 papers)

  1. Diffuse Large B-Cell Lymphoma Presenting in a Background of Rosai-Dorfman Disease.
    Wu C, Meyer A, Tun AM, et al. · Case Rep Hematol · 2026 · Derived
    PubMed: PMID 42158929 · NCT04884035 · Lymphoma, B-Cell
  2. PROs vs clinician-reported adverse events in a large clinical trial: findings from the phase 3 POLARIX study.
    Thompson C, Trněný M, Morschhauser F, et al. · Blood · 2026 · Derived
    PubMed: PMID 40997297 · NCT03274492 (POLARIX) · Lymphoma, Large B-Cell, Diffuse
  3. Polatuzumab Vedotin Combined With R-ICE (PolaR-ICE) as Second-Line Therapy in Diffuse Large B-Cell Lymphoma.
    Shouse G, Matasar M, Chen L, et al. · Am J Hematol · 2026 · Derived
    PubMed: PMID 41845899 · NCT04665765 · Lymphoma, Large B-Cell, Diffuse
  4. Mosunetuzumab plus polatuzumab vedotin in relapsed/refractory MCL after BTK inhibitor therapy: a phase 2 study.
    Budde LE, Kamdar M, Assouline SE, et al. · Blood · 2026 · Derived
    PubMed: PMID 42013019 · NCT03671018 · Lymphoma, B-Cell

2025 (8 papers)

  1. Mosunetuzumab plus Pola-CHP compared with Pola-R-CHP in previously untreated DLBCL: final results from a phase 2 study.
    Westin J, Phillips TJ, Mehta A, et al. · Blood Adv · 2025 · Derived
    PubMed: PMID 39908481 · NCT03677141 · Lymphoma, B-Cell
  2. Preclinical advances in glofitamab combinations: a new frontier for non-Hodgkin lymphoma.
    Sam J, Leclercq-Cohen G, Gebhardt S, et al. · Blood · 2025 · Derived
    PubMed: PMID 40749164 · NCT03467373 · Lymphoma, B-Cell
  3. Remission Assessment by Circulating Tumor DNA in Large B-Cell Lymphoma.
    Roschewski M, Kurtz DM, Westin JR, et al. · J Clin Oncol · 2025 · Derived
    PubMed: PMID 40802906 · NCT04231877 · Lymphoma, Large B-Cell, Diffuse
  4. Five-Year Outcomes of the POLARIX Study Comparing Pola-R-CHP and R-CHOP in Patients With Diffuse Large B-Cell Lymphoma.
    Morschhauser F, Salles G, Sehn LH, et al. · J Clin Oncol · 2025 · Derived
    PubMed: PMID 40991874 · NCT03274492 (POLARIX) · Lymphoma, Large B-Cell, Diffuse
  5. Glofitamab Combined With Pola-R-CHP or R-CHOP as First Therapy in Younger Patients With High-Risk Large B-Cell Lymphoma: Results From the COALITION Study.
    Minson A, Verner E, Giri P, et al. · J Clin Oncol · 2025 · Derived
    PubMed: PMID 40532125 · NCT04914741 (COALITION) · Lymphoma, Large B-Cell, Diffuse
  6. Efficacy and Safety of Glofitamab Plus Polatuzumab Vedotin in Relapsed/Refractory Large B-Cell Lymphoma Including High-Grade B-Cell Lymphoma: Results From a Phase Ib/II Trial.
    Hutchings M, Sureda A, Bosch F, et al. · J Clin Oncol · 2025 · Derived
    PubMed: PMID 41115257 · NCT03533283 · Lymphoma, Non-Hodgkin
  7. Subgroup analysis of older patients ≥60 years with diffuse large B-cell lymphoma in the phase 3 POLARIX study.
    Hu B, Reagan PM, Sehn LH, et al. · Blood Adv · 2025 · Derived
    PubMed: PMID 40085955 · NCT03274492 (POLARIX) · Lymphoma, Large B-Cell, Diffuse
  8. Mosunetuzumab Plus Polatuzumab Vedotin in Transplant-Ineligible Refractory/Relapsed Large B-Cell Lymphoma: Primary Results of the Phase III SUNMO Trial.
    Budde LE, Zhang H, Kim WS, et al. · J Clin Oncol · 2025 · Derived
    PubMed: PMID 41037766 · NCT05171647 (SUNMO) · Lymphoma, Non-Hodgkin

2024 (5 papers)

  1. Ethnic sensitivity assessment: Polatuzumab vedotin pharmacokinetics in Asian and non-Asian patients with previously untreated diffuse large B-cell lymphoma in POLARIX.
    Liao MZ, Deng R, Gibiansky L, et al. · Clin Transl Sci · 2024 · Derived
    PubMed: PMID 37864313 · NCT03274492 (POLARIX) · Lymphoma, Large B-Cell, Diffuse
  2. Automated Lugano Metabolic Response Assessment in 18F-Fluorodeoxyglucose-Avid Non-Hodgkin Lymphoma With Deep Learning on 18F-Fluorodeoxyglucose-Positron Emission Tomography.
    Jemaa S, Ounadjela S, Wang X, et al. · J Clin Oncol · 2024 · Derived
    PubMed: PMID 38843483 · NCT02257567 · Lymphoma
  3. Mosunetuzumab with polatuzumab vedotin in relapsed or refractory aggressive large B cell lymphoma: a phase 1b/2 trial.
    Budde LE, Olszewski AJ, Assouline S, et al. · Nat Med · 2024 · Derived
    PubMed: PMID 38072960 · NCT03671018 · Lymphoma, B-Cell
  4. Indirect Treatment Comparisons of Mosunetuzumab With Third- and Later-Line Treatments for Relapsed/Refractory Follicular Lymphoma.
    Bosch F, Kuruvilla J, Vassilakopoulos TP, et al. · Clin Lymphoma Myeloma Leuk · 2024 · Derived
    PubMed: PMID 37981564 · NCT02257567 · Lymphoma
  5. Polatuzumab vedotin plus rituximab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma: a cohort of a multicentre, single-arm, phase 1b/2 study.
    Abrisqueta P, González-Barca E, Panizo C, et al. · Lancet Haematol · 2024 · Derived
    PubMed: PMID 38190832 · NCT02600897 · Lymphoma, Large B-Cell, Diffuse

2023 (4 papers)

  1. Anti-CD20-atezolizumab-polatuzumab vedotin in relapsed/refractory follicular and diffuse large B-cell lymphoma.
    Topp MS, Eradat H, Florschütz A, et al. · J Cancer Res Clin Oncol · 2023 · Derived
    PubMed: PMID 35182224 · NCT02729896 · Lymphoma
  2. Polatuzumab vedotin in previously untreated DLBCL: an Asia subpopulation analysis from the phase 3 POLARIX trial.
    Song Y, Tilly H, Rai S, et al. · Blood · 2023 · Derived
    PubMed: PMID 36626583 · NCT03274492 (POLARIX) · Lymphoma, Large B-Cell, Diffuse
  3. Mosunetuzumab in combination with CHOP in previously untreated DLBCL: safety and efficacy results from a phase 2 study.
    Olszewski AJ, Phillips TJ, Hoffmann MS, et al. · Blood Adv · 2023 · Derived
    PubMed: PMID 37581593 · NCT03677141 · Lymphoma, B-Cell
  4. Polatuzumab vedotin with infusional chemotherapy for untreated aggressive B-cell non-Hodgkin lymphomas.
    Lynch RC, Poh C, Ujjani CS, et al. · Blood Adv · 2023 · Derived
    PubMed: PMID 36521030 · NCT04231877 · Lymphoma, Large B-Cell, Diffuse

2022 (5 papers)

  1. Polatuzumab vedotin in relapsed / refractory aggressive B-cell lymphoma.
    Varma G, Wang J, Diefenbach C, et al. · Expert Rev Anticancer Ther · 2022 · Derived
    PubMed: PMID 35726803 · NCT03274492 (POLARIX) · Lymphoma, Large B-Cell, Diffuse
  2. Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma.
    Tilly H, Morschhauser F, Sehn LH, et al. · N Engl J Med · 2022 · Derived
    PubMed: PMID 34904799 · NCT03274492 (POLARIX) · Lymphoma, Large B-Cell, Diffuse
  3. Polatuzumab vedotin plus bendamustine and rituximab in relapsed/refractory DLBCL: survival update and new extension cohort data.
    Sehn LH, Hertzberg M, Opat S, et al. · Blood Adv · 2022 · Derived
    PubMed: PMID 34749395 · NCT02257567 · Lymphoma
  4. Risk profiling of patients with relapsed/refractory diffuse large B-cell lymphoma by measuring circulating tumor DNA.
    Herrera AF, Tracy S, Croft B, et al. · Blood Adv · 2022 · Derived
    PubMed: PMID 35086141 · NCT02257567 · Lymphoma
  5. Polatuzumab vedotin plus obinutuzumab and lenalidomide in patients with relapsed or refractory follicular lymphoma: a cohort of a multicentre, single-arm, phase 1b/2 study.
    Diefenbach C, Kahl BS, McMillan A, et al. · Lancet Haematol · 2022 · Derived
    PubMed: PMID 34826412 · NCT02600897 · Lymphoma, Large B-Cell, Diffuse

2021 (3 papers)

  1. Asian race and origin have no clinically meaningful effects on polatuzumab vedotin pharmacokinetics in patients with relapsed/refractory B-cell non-Hodgkin lymphoma.
    Shi R, Lu T, Ku G, et al. · Cancer Chemother Pharmacol · 2021 · Derived
    PubMed: PMID 32770353 · NCT01691898 (ROMULUS) · Lymphoma, Large B-Cell, Diffuse
  2. Exposure-safety and exposure-efficacy analyses of polatuzumab vedotin in patients with relapsed or refractory diffuse large B-cell lymphoma.
    Lu T, Gibiansky L, Li X, et al. · Leuk Lymphoma · 2021 · Derived
    PubMed: PMID 32705923 · NCT02257567 · Lymphoma
  3. US cost-effectiveness of polatuzumab vedotin, bendamustine and rituximab in diffuse large B-cell lymphoma.
    Betts KA, Thuresson PO, Felizzi F, et al. · J Comp Eff Res · 2021 · Derived
    PubMed: PMID 33028076 · NCT02257567 · Lymphoma

2020 (2 papers)

  1. Polatuzumab vedotin in combination with immunochemotherapy in patients with previously untreated diffuse large B-cell lymphoma: an open-label, non-randomised, phase 1b-2 study.
    Tilly H, Morschhauser F, Bartlett NL, et al. · Lancet Oncol · 2020 · Derived
    PubMed: PMID 31101489 · NCT01992653 · Lymphoma, Non-Hodgkin
  2. Polatuzumab Vedotin in Relapsed or Refractory Diffuse Large B-Cell Lymphoma.
    Sehn LH, Herrera AF, Flowers CR, et al. · J Clin Oncol · 2020 · Derived
    PubMed: PMID 31693429 · NCT02257567 · Lymphoma

2019 (1 paper)

  1. Polatuzumab vedotin or pinatuzumab vedotin plus rituximab in patients with relapsed or refractory non-Hodgkin lymphoma: final results from a phase 2 randomised study (ROMULUS).
    Morschhauser F, Flinn IW, Advani R, et al. · Lancet Haematol · 2019 · Derived
    PubMed: PMID 30935953 · NCT01691898 (ROMULUS) · Lymphoma, Large B-Cell, Diffuse

2015 (1 paper)

  1. Safety and activity of the anti-CD79B antibody-drug conjugate polatuzumab vedotin in relapsed or refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukaemia: a phase 1 study.
    Palanca-Wessels MC, Czuczman M, Salles G, et al. · Lancet Oncol · 2015 · Derived
    PubMed: PMID 25925619 · NCT01290549 · Lymphoma, Non-Hodgkin

Sources and methodology

This page summarizes published evidence for general reference and does not constitute medical advice. For clinical decisions, consult the linked primary publications and your healthcare provider. Data sourced from PubMed and the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI).