In the European Myeloma Network we conduct large prospective clinical trials, phase II, phase III trials. We have completed a trial recently with 1,500 patients newly diagnosed multiple myeloma, transplant eligible patients where we treated patients with bortezomib induction, high dose melphalan, transplant followed by consolidation and lenalidomide maintenance for an indefinite time until progressive disease occurs. In this trial of course patients relapse and they progress and we designed the trial for a second line therapy in this group of patients and this is the EMN-011 trial.
We present here at ASH 2018 for the first time results of an interim analysis of that trial in 60 patients with a follow up of 18 months.
What is the second line therapy?
The hypothesis is that if patients become refractory or progressive on bortezomib and lenalidomide that we treat them with second generation proteasome inhibition and IMiD. For this trial we chose carfilzomib combined with pomalidomide and dexamethasone.
What did you find?
60 patients were treated and they tolerated the treatment quite well. The treatment consisted of eight cycles of carfilzomib, pomalidomide, dexamethasone and we analysed the response and tolerability after four induction cycles and after eight cycles before patients entered the maintenance phase with pomalidomide continuously. The response was very good – the CR rate was 42%, the VGPR rate was 76% and all but one patient responded with a PR or better so this is an effective regimen in this resistant and some of them refractory group of patients.
Should this impact clinical practice?
Yes because it’s well tolerated, very few adverse events. The progression free survival at this time is 18 months and overall survival is not reached yet but it looks very favourable. So we think that this will be a practice changing combination of new drugs but we have to await longer follow up, of course. This is the first interim analysis and the next analysis will be done one year from now.