ICML 2023 | Insights into the BrECADD regimen in HL & results from the GHSG HD21 study

With an escalated BEACOPP regimen, we have a highly effective regimen. It was established in the last millennium, actually. And since then we tried to de-escalate and to tailor it to the individual patient’s needs because it’s a burdensome treatment for patients. And we know that roughly three out of four could be cured also without this kind of very intensive treatment. With the use of brentuximab vedotin as an antibody drug conjugate with a much better risk-to-benefit profile, we remodeled the regimen towards the BrECADD regimen and we hoped to eliminate some of the most important toxicities from the regimen. We have shown this already at last year’s ASH, this was highly successful. We don’t have any [inaudible] toxicity, for example, much less use of transfusions, almost no neuropathy and so forth. So it’s an outpatient regimen. And so it was much more important now to see if it also at the same time maintains the efficacy. We have a combined primary endpoint in the HD21 trial. The international trial with nine countries all over the world, a global trial with 1500 patients enrolled. And this was now an interim analysis after hundred of 154 events planned have occurred, and we needed to exclude or to not meet a hazard ratio of 1.02 in order to conclude that it is non-inferior. What we observed in terms of efficacy is a hazard ratio way below of 0.63. So we can safely conclude that this regimen is non-inferior to escalated BEACOPP. In fact, if you look at the PFS curves, then then you’ll see that the BreCADD regimen does better than the escalated BEACOPP in terms of PFS at three years. We are very close to 95% with 94.9%, which is due to the elimination of early relapses and progresses actually.