EHA 2025 | Results of the Phase III POLARGO trial: POLA-R-GEMOX for the treatment of R/R DLBCL

So we had the opportunity to present for the first time our data from the POLARGO trial. This was an internationally conducted randomized phase three trial for patients with relapsed or refractory large cell lymphoma who were deemed transplant-eligible. Patients had to be naive to polatuzumab and relapsed or be refractory to one or more prior lines of therapy, and patients were randomized in a one-to-one fashion to receive either R-GEMOX as a standard of care or R-GEMOX plus polatuzumab. So this pola plus R-GEMOX is the POLARGO regimen. We found that the study was positive for its primary endpoint of overall survival with a hazard ratio adjusted for covariates of 0.6. What this translates to, of course, is a 40% lower risk of death for patients that were treated with the POLARGO regimen. Quantitatively, this translated to an improvement in overall survival from 12 to 19 months, as well as we saw key improvements in other secondary endpoints like progression-free survival, as well as overall and complete response rates, where we saw a doubling of both the overall response and complete response rates with the addition of polatuzumab. We did see some increase in toxicity, and this, of course, has to be tempered by the fact that patients received a lot more study therapy because they were responding to treatment. Patients who were treated with R-GEMOX only got a median of four cycles of treatment. Patients treated with POLARGO regimen got a median of seven and a half cycles. So with more treatment should come more toxicity, and this certainly was the case. There was, however, an increase in grade five toxicities from four to 11% for patients treated with polatuzumab over that longer duration of exposure. The most common cause of death other than progression was infectious complications. And the most common infectious complication leading to death in POLARGO trial was COVID-19. And it’s worth noting that this was conducted during a time that was considered more peak COVID. But despite this imbalance in grade 5 toxicity, we did see this significant improvement in survival, really clarifying that the POLARGO regimen may be a reasonable standard for patients who need a second-line cytotoxic-based approach, either as destination therapy or potentially as debulking or bridging therapy, antecedent to CAR T-cell therapy.

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