So, yes, so, you know, the POLARIX regimen, or Pola-R-CHP, has been established as a standard of care in the treatment of intermediate or high-risk, newly diagnosed large-cell lymphoma up to age 80 on the basis of the POLARIX trial, which proved in a randomized, double-blinded fashion an improvement in progression-free survival without clear overall survival benefit in such patients...
So, yes, so, you know, the POLARIX regimen, or Pola-R-CHP, has been established as a standard of care in the treatment of intermediate or high-risk, newly diagnosed large-cell lymphoma up to age 80 on the basis of the POLARIX trial, which proved in a randomized, double-blinded fashion an improvement in progression-free survival without clear overall survival benefit in such patients. You know, oftentimes we see certain results in randomized trials, and when you put it through the crucible of real-world evidence, the benefits are more difficult to discern. So we pose the question of whether in a Medicare patient population, age 66 plus, whether benefits could be seen with use of the POLARIX regimen in routine clinical practice. So we used Medicare claims data looking at patients who were Medicare eligible at age 66 and beyond with newly diagnosed large cell lymphoma who were treated either with the POLARIX regimen or R-CHOP. And for this study, we looked at time-to-next treatment as our proxy for progression-free survival using claims-based data with secondary outcomes, including overall survival. We found a lot of patients that were treated thusly. We had over 1,300 patients treated with POLARIX and over 4,000 patients treated with R-CHOP, and we were able to describe their clinical characteristics, age, ethnicity, comorbidities, geography, in quite clear detail.
Encouragingly, we found that in this real-world evidence analysis that the benefits seen in POLARIX really did hold up quite well in a Medicare patient population in the real world. With an improvement in time-to-next treatment, our PFS proxy with a hazard ratio of 0.82, that was statistically significant. Interestingly, we also did not see a clear overall survival benefit. There was directionality favoring POLARIX in a non-statistically significant fashion in univariate analysis. We ran a number of adjusted analyses, including one called IPTW. And it turned out that with the IPTW adjustment, we actually did have borderline statistical significance for overall survival with a hazard ratio of 0.9, just excluding one. You know, this is one analysis of many analyses. We didn’t adjust for multiple analyses. I would say that the results here are aligned with POLARIX, clear improvement in PFS, directionality seeming to favor overall survival without clarity on that point, but really affirming for me the utility of the POLARIX regimen in reducing the risk of progression here in older patients in the United States.
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