CLL12 will be presented tomorrow in the late breaking session by Dr Petra Langerbeins who has been the lead in this study for several years and working on that. This is basically a trial that is checking on an important paradigm that we have in treatment of indolent lymphoma. In CLL it’s no exception because we know that patients who do not have any symptoms and who do not have any shifts in their blood count, have normal blood count but we know that they have a CLL, there are no data that suggest that starting direct treatment has any long-term benefit for those with regard to survival. So there were previously studies done, for instance also by the German CLL Study Group like the CLL7 trial where it was checked whether starting early treatment in patients, particularly in those with high risk features, has any benefit in the long run and no trial was able to show that yet.
In CLL12 this was to be tested again but this time not with chemoimmunotherapy but with BTK inhibition with ibrutinib. So patients were first of all stratified according to their risk features, so TP53 mutational status, status of deletions, IGHV status and all of that, then they were randomised to either receive a placebo or ibrutinib. All of these patients were Binet A, so early stage patients without symptoms and which outside of clinical trial wouldn’t be treated at all. The primary endpoint of this analysis was the event free survival. Now the primary analysis that will be presented tomorrow will show whether there is any treatment in the event free survival or in time to next treatment, meaning time to actually the first line treatment in those patients. We’ll see the data tomorrow.
The trial suggests at this stage now that time to next treatment will be significantly delayed in patients when they start ibrutinib in contrast to patients who take placebo. In the long run, the trial will have a long follow-up, we will test and check whether these patients also have an overall survival impact and in that case this would have direct implications on the way we manage CLL at the moment.