Transplant-ineligible diffuse large B-cell lymphoma: pola-BR delivers significant OS improvement vs BR

  • Sehn LH & al.
  • J Clin Oncol
  • 6 Nov 2019

  • curated by David Reilly
  • Univadis Clinical Summaries
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Takeaway

  • Polatuzumab vedotin combined with bendamustine and rituximab (pola-BR) demonstrated significantly improved survival outcomes vs BR alone in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) ineligible for autologous stem-cell transplantation (ASCT).

Why this matters

  • Patients with R/R DLBCL who are ineligible for ASCT, or who have relapsed following ASCT, have poor prognosis and limited therapeutic options.
  • This is the first study to demonstrate an OS benefit in this setting.  

Study design

  • Phase 2 study of pola-BR (n=40) vs BR (n=40) in patients with transplant-ineligible R/R DLBCL.
  • Funding: Genentech; F. Hoffmann-La Roche.

Key results

  • With pola-BR vs BR:
    • 40.0% complete response (CR; per independent review committee [IRC]) vs 17.5% (P=.026).
      • >90% concordance between IRC and investigator results.
    • 9.5 (95% CI, 6.2-13.9) months median PFS (per IRC) vs 3.7 (95% CI, 2.1-4.5) months: HR, 0.36; 95% CI, 0.21-0.63; P<.001.>
    • 12.4 (95% CI, 9.0-not estimable) months median OS vs 4.7 (95% CI, 3.7-8.3) months: HR, 0.42; 95% CI, 0.24-0.75; P=.002.
    • 46.2% experienced grade 3-4 neutropenia with pola-BR vs 33.3% with BR.
    • 41.0% experienced grade 3-4 thrombocytopenia with pola-BR vs 23.1% with BR.

Limitations

  • Limited sample size.