Retreatment with Polivy

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

This article responds to your request for information on Polivy® (polatuzumab vedotin) and retreatment. This response was developed according to the principles of evidence-based medicine and summarizes data from clinical trials and published medical literature.

Roche does not have any recommendations regarding retreatment with Polivy. Any decision on using Polivy for retreatment will be at the discretion of the treating physician taking into consideration individual risk-benefit.

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Last updated May 08, 2024


Considerations for retreatment with Polivy:

  • Dedicated clinical studies evaluating the risk-benefit balance of retreatment with Polivy have not been conducted.
    • In a trial amongst patients with R/R aggressive LBCL, two patients were retreated with Polivy and mosunetuzumab. One patient experienced a CR and one a PR for six months before progression.
      • In vitro, Polivy-resistant cells were used to assess the combinaed efficacy of Polivy and rituximab. The authors concluded that retreatment with this combination could be a therapeutic option for Polivy-resistant tumors.
        • In a retrospective study amongst patients with R/R B-cell lymphomas, a patient receiving bridging therapy was retreated with five cycles of Polivy-BR after failure of CAR T-cell therapy. The patient achieved a PR, enabling them to undergo consolidative alloHCT.
          • Polivy dosing beyond six cycles was permitted in phase 1 and 2 trials, but was capped to six or eight cycles in subsequent trials due to the cumulative nature of PN.
            • A time-to-event analysis of Polivy-induced PN, suggested that capping Polivy treatment duration to six to eight cycles at doses of 1.8–2.4 mg/kg would result in PN incidences comparable to other antimicrotubule agents.


              alloHCT=allogeneic hematopoietic cell transplantation MMAE=mono-methyl auristatin E
              CAR-T=chimeric antigen receptor T-cell Polivy-BR=polatuzumab vedotin, bendamustine, and rituximab
              CDC=complement dependent cytotoxicity PN=peripheral neuropathy
              CR=complete response PR=partial response
              DLBCL=diffuse large B cell lymphoma R/R=relapsed/refractory
              LBCL=large b cell lymphoma

              Experience from clinical trials

              A phase 1b/2 trial evaluated mosunetuzumab in combination with Polivy in R/R aggressive LBCL.[1] Patients with an initial CR, who subsequently progressed, were permitted to receive retreatment with Polivy and mosunetuzumab. Two patients were retreated this way; one experienced another CR and one a PR. Both responses lasted more than six months before progression. Additionally, five patients were retreated with Polivy in combination with other anti-lymphoma therapies, however retreatment outcomes for these patients were not reported.

              Experience from pre-clinical trials

              In vitro, Polivy resistant cells were used to assess the combined efficacy of Polivy and rituximab.[2] Pretreatment with Polivy enhanced rituximab-induced CDC sensitivity in two Polivy-resistant cells with distinct mechanisms of resistance: increased MDR1 or decreased Bim expression. Combination treatment of Polivy with rituximab enhanced antitumor activity in STR-428-Pola-R xenografted mice. The authors concluded that retreatment with Polivy in combination with rituximab could be a therapeutic option in patients with Polivy-resistant tumors.

              Published reports of retreatment with Polivy

              A retrospective multicenter study evaluated Polivy as a salvage and bridging treatment in adults with R/R LBCL who had failed at least two lines of therapy.[3] A patient receving bridging therapy was retreated with Polivy after failure of CAR T-cell therapy. Patient initially received three cycles of Polivy-BR, achieved a PR, started CAR T-cell therapy but relapsed after two months. The patient was retreated with five cycles of Polivy-BR and achieved a PR again, enabling him to undergo consolidative alloHCT. 

              Retreatment considerations

              In Phase 1 and 2 trials with Polivy in DLBCL, dosing of Polivy beyond six cycles was permitted.[4,5] However, ongoing and future trials are limited to six or eight Polivy cycles because of the

              • apparent cumulative nature of peripheral neuropathy leading to study treatment discontinuation, and
                • supportive exposure-response and time-to-event analysis.

                  A time-to-event analysis concluded that the risk of grade ≥2 PN increased with increasing exposure to antibody‐conjugated MMAE and treatment duration.[6] The model‐estimated PN incidence suggested that capping treatment duration to six to eight Polivy cycles at doses of 1.8–2.4 mg/kg would result in PN incidences comparable to other antimicrotubule agents.


                  1. Budde LE, Olszewski AJ, Assouline S, et al. Mosunetuzumab with polatuzumab vedotin in relapsed or refractory aggressive large B cell lymphoma: a phase 1b/2 trial. Nat Med 2024;30:229-239.
                    1. Kawasaki N, Tomita M, Yamashita-Kashima Y, et al. Efficacy of retreatment with polatuzumab vedotin in combination with rituximab in polatuzumab vedotin-resistant DLBCL models. Leuk Lymphoma 2023;64:1938-1948.
                      1. Liebers N, Duell J, Fitzgerald D, et al. Polatuzumab vedotin as a salvage and bridging treatment in relapsed or refractory large B-cell lymphomas. Blood Adv 2021;5:2707-2716.
                        1. Palanca-Wessels MC, Czuczman M, Salles G, et al. 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;16:704-15.
                          1. Morschhauser F, Flinn IW, Advani R, et al. 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). Lancet Haematol 2019;6:e254-e265.
                            1. Lu D, Gillespie WR, Girish S, et al. Time-to-Event Analysis of Polatuzumab Vedotin-Induced Peripheral Neuropathy to Assist in the Comparison of Clinical Dosing Regimens. CPT Pharmacometrics Syst Pharmacol 2017;6:401-408.

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