Polatuzumab Vedotin Plus Rituximab, Gemcitabine, and Oxaliplatin in Relapsed or Refractory Diffuse Large B-Cell Lymphoma: Results From the Phase III, Randomized POLARGO Trial.
Matthew Matasar, Zhiming Li, Theodoros P Vassilakopoulos et al.
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In 30 seconds
The phase III, randomized, open-label POLARGO trial compared polatuzumab vedotin plus rituximab, gemcitabine, and oxaliplatin (Pola-R-GemOx) with R-GemOx in patients with relapsed or refractory diffuse large B-cell lymphoma who were ineligible for autologous stem cell transplant. Among 255 randomized patients, after a median follow-up of 24.6 months, Pola-R-GemOx was associated with longer overall survival: median 19.5 months versus 12.5 months, with a hazard ratio for death of 0.6 (95% CI, 0.43 to 0.83; P = .0017). Peripheral neuropathy and fatal adverse events were more frequent with Pola-R-GemOx.
Key findings
- Median overall survival was 19.5 months with Pola-R-GemOx versus 12.5 months with R-GemOx.
- The hazard ratio for death with Pola-R-GemOx versus R-GemOx was 0.6 (95% CI, 0.43 to 0.83; P = .0017).
- Peripheral neuropathy occurred in 73 (57%) patients receiving Pola-R-GemOx versus 36 (29%) receiving R-GemOx, and was primarily grade 1.
- Fatal adverse events occurred in 15 (12%) patients with Pola-R-GemOx and five (4%) with R-GemOx, largely driven by infections.
Why it matters
For transplant-ineligible patients with relapsed or refractory DLBCL, the trial provides randomized evidence that adding polatuzumab vedotin to R-GemOx can improve overall survival. The survival benefit should be considered alongside the higher frequency of peripheral neuropathy and fatal adverse events reported with the combination, particularly infections.
What to keep in mind
The trial was open-label, and median follow-up was 24.6 months; longer-term outcomes are not reported in the abstract.