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Polatuzumab vedotin in combination with venetoclax and rituximab for patients with R/R DLBCL

Apr 2, 2024
Learning objective: After reading this article, learners will be able to cite a new development in the treatment of diffuse large B-cell lymphoma.

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Patients with released/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are ineligible for transplant have limited treatment options and a poor prognosis; however, novel combination therapies may improve outcomes.1 Polatuzumab vedotin, an antibody-drug conjugate targeting CD79b, is being evaluated in combination with several other agents for the treatment of patients with R/R DLBCL.1 The Lymphoma Hub previously covered outcomes of polatuzumab vedotin in combination with venetoclax and rituximab and primary analysis results from the phase Ib/II GO29834 trial (NCT02600897) investigating the combination of polatuzumab vedotin, rituximab, and lenalidomide in patients with R/R DLBCL. Here, we summarize the results from the GO29834 trial, published by Abrisqueta et al.1 in Lancet Haematology.

Study design1

  • This was an open-label, multicenter, phase Ib/II trial (Figure 1)
  • The primary safety and efficacy outcomes were the maximum tolerated dose of lenalidomide and the complete response rate, respectively

Figure 1. Phase Ib/II GO29834 trial design* 

IV, intravenous; RP2D, recommended phase II dose.
*Data from Abrisqueta, et al.1

Key findings1

  • In total, 57 patients were included (phase Ib, n = 18; phase II, n = 39) with a median age of 71 years.
  • The efficacy cohort (n = 49) included patients from cohort C (n = 10) of the phase Ib portion and patients from the phase II portion (n = 39), while the safety cohort included all patients (n = 57); median follow-up was 11.8 months.

Phase Ib

  • No dose-limiting toxicities were observed
    • One patient in cohort C had a fatal adverse event (AE) deemed unrelated to the study treatment
  • 20 mg lenalidomide was chosen as the recommended phase II dose


  • Overall, 98%, 77%, and 40% of patients experienced ≥1 any grade, Grade 3–4, and serious AEs, respectively.
    • The most common Grade 3–4 AEs were neutropenia (61%), and thrombocytopenia (14%).
    • The most common serious AEs were infection (18%), pyrexia (18%), and tumor flare (4%).
  • Overall, 35 patients died, most commonly due to disease progression (n = 26) and AEs (n = 5).
    • One patient died due to a treatment-related AE (neutropenic sepsis).

Induction response

  • Induction response rates are shown in Figure 2
  • Median duration of response was 9.3 months

Figure 2. Induction response rates in the efficacy population (n = 49) using modified Lugano criteria*

*Data from Abrisqueta, et al.1

Survival outcomes

  • Median progression-free survival (PFS) and overall survival were 6.0 months and 11.9 months, respectively.
    • Among patients with a complete response, median PFS and overall survival were not reached.
  • Estimated 12- and 24-month PFS rates are shown in Figure 3.

Figure 3. Estimated 12- and 24-month PFS rates* 

PFS, progression-free survival.
*Data from Abrisqueta, et al.1


Key learnings
  • Polatuzumab vedotin in combination with rituximab and lenalidomide was associated with clinical activity and an acceptable safety profile in patients with R/R DLBCL.
  • While responses were encouraging, they did not meet the prespecified threshold of 40%.

  1. Abrisqueta P, González-Barca E, Panizo C, et al. 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. Lancet Haematol. 2024;11(2):e136-e146. DOI: 1016/S2352-3026(23)00345-9

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