IFM, the Intergroupe Francophone du Myelome scientific society of myeloma in France has launched an attempt to keep the melphalan prednisone backbone into new triplet combinations where the proteasome inhibition by bortezomib will be replaced by carfilzomib, the reason for that being that we wanted to give more prolonged treatment and we know it’s feasible for carfilzomib but not for bortezomib. We also know it’s feasible for carfilzomib in non-transplant eligible patients and we know it’s feasible even for patients aged above 75 and possibly above 80. So we wanted to run this KMP, carfilzomib, melphalan, prednisone study, nine cycles of induction that has already been presented and has already been published.
But then the idea was not to stop on targeted treatment, stop the melphalan prednisone because it cannot be given continuously, it’s too risky for the patients, but continue the carfilzomib. The idea initially of replacing bortezomib by carfilzomib being the fact that the safety profile of carfilzomib was good in the long run, including elderly patients. So we validated through this carfilzomib maintenance one year study which is the second part of the KMP-K study IFM 2012-03. We validated in very elderly patients, median age above 75, from 75-80, we validated the fact that it was manageable to give carfilzomib. We actually haven’t increased at all the incidence rate of problematic AEs. The carfilzomib was given weekly, which was very convenient to patients, at 36mg/m2 in the maintenance part.
We also validated the fact that the efficacy when you add carfilzomib to the combination is quite remarkable. The median PFS was very similar to the median EFS, so the risk of progression was very similar to the risk of progression including the safety issues, which means that there were very few safety issues to the patients. We have an excellent CR rate and a very prolonged PFS which is largely better than three years which, for this group of patients, has only been reached so far by the MAIA study which is daratumumab, lenalidomide, dexamethasone and includes two expensive drugs. Here with KMP we only have one expensive drug so I know that in the context of the US system it’s not necessarily a very interesting triplet based regimen but in the context of a non-US system where cost is one of the most important aspects of deciding which regimen should be picked or not, on top of efficacy and safety but also cost, this regimen appears to be extremely appealing, extremely interesting.