Polatuzumab Vedotin Plus Rituximab, Gemcitabine, and Oxaliplatin in Relapsed or Refractory Diffuse Large B-Cell Lymphoma: Results From the Phase III, Randomized POLARGO Trial
In brief
Polatuzumab combo extends median survival by about seven months in transplant-ineligible relapsed DLBCL
In the phase III POLARGO trial, adding polatuzumab vedotin to rituximab, gemcitabine and oxaliplatin reduced the risk of death by 40% and lengthened median overall survival from 12.5 to 19.5 months. The regimen caused more peripheral neuropathy and a higher rate of infection-related deaths, underscoring a trade-off that clinicians must weigh.
- Journal
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology (Q1)
- Published
- 6 July 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Matthew Matasar, Zhiming Li, Theodoros P Vassilakopoulos, Juan-Manuel Sancho, Andreas Viardot, Andrew McMillan, et al.
- PMID
- 42407012
- DOI
- 10.1200/JCO-25-02849
Why clinicians should know about it
- Picked for Hematology (top studies of the week, 8 November 2026): Significant OS improvement with Pola-R-GemOx in transplant-ineligible R/R DLBCL
Abstract
PURPOSE: Patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) face an unfavorable prognosis once first-line treatment fails; therefore, there is an unmet need for new treatment options. We evaluated the efficacy and safety of polatuzumab vedotin plus rituximab, gemcitabine, and oxaliplatin (Pola-R-GemOx) as an alternative therapy in patients with transplant-ineligible R/R DLBCL. METHODS: The phase III POLARGO trial was a randomized, open-label, global study. Following a Pola-R-GemOx safety run-in (n = 15), patients with R/R DLBCL (not otherwise specified or transformed indolent lymphoma) ineligible for autologous stem cell transplant were randomly assigned 1:1 to receive Pola-R-GemOx or R-GemOx alone every 21 days for up to eight cycles. The primary end point was overall survival (OS). RESULTS: In total, 255 patients were randomly assigned to receive Pola-R-GemOx (n = 129) or R-GemOx (n = 126). After a median follow-up of 24.6 months, patients receiving Pola-R-GemOx versus R-GemOx had a significantly lower risk of death (hazard ratio, 0.6 [95% CI, 0.43 to 0.83]; P = .0017) with a median OS of 19.5 months (95% CI, 13.3 to not estimable) versus 12.5 months (95% CI, 8.9 to 15.8). The most common grade 3/4 adverse events (AEs) were thrombocytopenia and neutropenia. Peripheral neuropathy was more common with Pola-R-GemOx (n = 73 [57%]) versus R-GemOx (n = 36 [29%]) and was primarily grade 1. Fatal AEs occurred in 15 (12%) and five (4%) patients in the Pola-R-GemOx and R-GemOx groups, respectively, and were largely driven by infections (including COVID-19). CONCLUSION: Pola-R-GemOx significantly improved OS compared with R-GemOx, offering an additional treatment option in patients with transplant-ineligible R/R DLBCL.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.