Arthur presented on behalf of the Intergroupe Francophone du Myélome group for multiple myeloma, the IFM group, the second part, the maintenance part, of a clinical trial called IFM 2012-03 which was an attempt to demonstrate that we could take the standard of care Revlimid from prednisone, get rid of Velcade, a first in class bortezomib inhibitor, and replace it by carfilzomib, a second generation epoxyketone that you could give on a longer run because it’s safer, especially regarding asthenia, diarrhoea and neurotoxicity. So we have already presented and we have already published the first part of that study which was a KMP induction regimen for non-transplant eligible patients, elderly. Especially in that study we have recruited patients above 75, so elderly and frail. We demonstrated that it was feasible, it was a phase I so dose escalation, but we demonstrated it was feasible, we demonstrated it was very active but we know that independently of the activity you get initially if you can continue the treatment at least for some while, some months, the patient will ultimately relapse. So we’ve had added to this regimen the maintenance part which is what we report here.
So what we report is that a great number of these patients were capable after this induction nine cycles phase to enter the maintenance. Most of the patients who entered the maintenance actually finished the maintenance, terminated the maintenance so were able to get through the one year, thirteen cycles of maintenance. Only four patients were not able to complete the maintenance because of either progression or some safety issue. But globally, overall, the feeling is that it’s feasible to give carfilzomib for a nine month induction then one year maintenance. It was given at 36mg/m2 for the maintenance although for the initial part it was at 56 or 70, it was an escalated dose. 36 for a year long is very manageable for elderly patients, even elderly and frail patients. The patients were not sick of having to come to hospital because it was carfilzomib given on a weekly basis which is convenient to the patients and not too cumbersome and less heavy than twice a week.
So globally this study demonstrated that we can use carfilzomib in elderly patients up front. Now the thing is that probably not under the carfilzomib melphalan prednisone regimen because we know this one will unlikely be approved but possibly this can serve for the use of carfilzomib on, for example, K/Rev/Dex combination for the future in non-transplant eligible patients.