30 minute infusion of isatuximab shows potential in newly diagnosed multiple myeloma

Prof Philippe Moreau - University Hospital of Nantes, Nantes, France

The study is about the use of isatuximab, that is an anti-CD38 monoclonal antibody, in combination with other agents to treat patients with multiple myeloma. Isatuximab is an IV drug and when we started to use isatuximab the duration of the IV infusion was 75 minutes. So now this article is summarising, in fact, the use of a 30-minute infusion of isatuximab in order to improve the convenience for patients and also for the medical staff.

What was the study design?

In that study we have treated patients with a quadruplet combination. The quadruplet combination is isatuximab IV with bortezomib, lenalidomide and dexamethasone, what we calling Isa-VRd, or another combination that is isatuximab plus bortezomib, cyclophosphamide and dexamethasone, Isa-VCd. We have treated those patients as a part of frontline therapy; those patients were elderly patients, transplant ineligible. During the maintenance phase we have combined isatuximab, lenalidomide and dexamethasone during a long period of time. During the first part of the study, the initial induction phase, isatuximab was proposed IV during 75 minutes and then we tried to reduce the duration of the IV infusion to 30 minutes and that we did only during the maintenance part of the study.

What were the results?

During the study we have treated 45 patients in maintenance treatment and we have switched to the new 30-minute infusion instead of 75 minutes. Overall we have administered 210 fast infusions to those patients during the maintenance part. In fact, it was possible to demonstrate that the feasibility was really good, in fact. The treatment was very well tolerated without any adverse events and, of course, the efficacy is totally identical. So the conclusion of the study is that we can administer isatuximab IV in 30 minutes instead of 75. The efficacy identical, the tolerance is very, very good indeed. For patients, of course, that’s very convenient, they are staying during a shorter period of time in the hospital, and also for the nurses that are taking care of patients in clinical practice that’s truly time saving as well for the healthcare providers.

What could be the impact of these results?

I believe that the impact will be important because you know that in the outpatient clinics where isatuximab is usually proposed in combination with other drugs we need for the patients to stay the shortest period of time as possible in the hospital so we can have more patients in the daily practice. That’s very important. But, of note, we also know that there is a very important study that is ongoing with isatuximab and the name of the study is IRAKLIA. We don’t yet have the results but IRAKLIA is currently comparing isatuximab IV versus isatuximab subcutaneous. So the next step for us is to have now isatuximab that is a very important drug that is approved, in fact, by the authorities both in the frontline setting but also in the relapsed setting, now we are waiting for a subcutaneous formulation. But already we have this IV short period of time possibility that is very important for patients and for healthcare providers.

Where does the study sit in the treatment landscape?

The study is quite important in the treatment landscape because isatuximab is already approved in the relapsed setting in combination with pomalidomide and dexamethasone, the Isa-Pd combination, based on the results of the ICARIA study published quite a long time ago, approved both by the FDA and EMA. Isatuximab is also approved in the relapsed setting in combination with carfilzomib and dexamethasone according to the results of the IKEMA study. Isa-Kd is also approved by the FDA and EMA. And more recently, isatuximab was tested in combination with bortezomib, lenalidomide and dexamethasone, the Isa-VRd, based on the results of the IMROZ study. The study is positive so Isa-VRd is now approved, in fact, for the frontline treatment of patients that are not eligible for autologous stem cell transplantation.

So you see now that there is a big impact on the routine practice, both in the frontline setting but also for relapsed myeloma patients.