The POLARGO study demonstrated that Polatuzumab Vedotin plus Rituximab, Gemcitabine, and Oxaliplatin (Pola-R-GemOx) significantly improved overall survival and complete response rates compared to Rituximab plus Gemcitabine and Oxaliplatin (R-GemOx) in patients with transplant-ineligible relapsed or refractory diffuse large B-cell lymphoma. The regimen showed a 40% reduction in the risk of death and a 63% reduction in the risk of progression or death with Pola-R-GemOx. While the safety profile of Pola-R-GemOx showed additive toxicity, most events were manageable, with peripheral neuropathy being primarily grade 1.
Study
|
Randomized, open-label, global, phase 3 study [POLARGO, NCT04182204] |
| Transplant-ineligible relapsed or refractory diffuse large B-cell lymphoma |
| Polatuzumab Vedotin+Rituximab+Gemcitabine+Oxaliplatin (n=129) vs Rituximab+Gemcitabine+Oxaliplatin (n=126) for up to 8 cycles
|
Efficacy
|
ORR at EOT: 52.7% vs 24.6% (Pola-R-GemOx vs. R-GemOx) |
| CR at EOT: 40.3% vs 19.0% |
| mOS: 19.5 mos vs 12.5 mos (HR 0.60 [0.43-0.83]) |
| mPFS: 7.4 mos vs 2.7 mos (HR 0.37 [0.27-0.51])
|
Safety
|
Grade 3-4 AEs: Thrombocytopenia (34.4% vs 26.4%), neutropenia (33.6% vs 30.4%), diarrhea (7.0% vs 0.8%), ALT increase (4.7% vs 0.8%) |
| Fatal AEs: 11.7% vs 4.0% |
| Treatment discontinuation due to AE: 23.4% vs 8.0%
|
J Clin Oncol. Published online July 6, 2026
http://doi.org/10.1200/JCO-25-02849
Reviewed by Ulas D. Bayraktar, MD on Aug 13, 2026
