ASH 2023 | Updated follow-up results of the Phase III GAIA/CLL13 trial

Yes, my colleague Moritz Fürstenau, also from Cologne, he presented now the 50 month follow-up of the GAIA/CLL13 study, where we compare three different venetoclax plus CD20 antibody-based treatment regimens versus chemoimmunotherapy for the younger patients and FCR for the elderly patients. All of them were physically fit and now, with the longer follow-up, we were able to compare each of the three different venetoclax plus and CD20 containing arms. So the one arm was venetoclax plus obinutuzumab. The other one was with the addition of ibrutinib, so a triplet combination. And then the third one was venetoclax plus rituximab. And what we do see is again confirming that venetoclax plus obinutuzumab, with or without ibrutinib, is much better than immunotherapy and also significantly better than rituximab plus venetoclax. So, the antibody in front-line therapy matters. Obinutuzumab is also a better combination partner with venetoclax, however, we do see a split of the curves for the progression-free survival between the triplet, with the addition of ibrutinib, versus not. Due to the fact that the p-value here was split and it should be below zero 0.025, it’s now at 0.03, so it’s not yet statistically significant. But at least when we look at subgroups of patients, we do see that those patients with an unmutated IGVH status, who tend to have earlier relapses, benefit significantly from the addition of ibrutinib. With respect to the safety profile, there are no new safety concerns. We do see, with respect to secondary neoplasias, more skin cancers in the chemoimmunotherapy arm and otherwise secondary neoplasia were similarly distributed.