IMS 2025 | The IRAKLIA trial: isatuximab subcutaneous via OBI versus IV in RRMM

If you look at CD38 monoclonal antibodies, so we have daratumumab and we have isatuximab. Daratumumab is subcutaneous on manual push route. Isatuximab today is still IV. And so the second talk I will be doing in Toronto is about the IRAKLIA Phase III study for registration. The objective of that study was to develop for the first time in myeloma a new type of subcutaneous formulation, which is called an OBI. So it is not manual push anymore. It’s based on a small device, an on-body injector, on-body delivery device. It’s a small piece and all you have to do is plug the vial into it, stick it to your skin, pull the ribbon, and then it’s totally automated, so you don’t have to do anything. The gauge of the needle is retracted, so you don’t see it; it only gets out into your skin when it’s stuck, when you put the ribbon and when it sticks to your skin, and the injection is very smooth. You don’t have the push; you don’t have the force of the nurse who tries to push this very thick product into your skin. So there are less local reactions, less systemic infusion-based reactions. The safety profile of the device is really, really good. Only nine patients experienced pain, but overall, it was really incredible. More than 97% of the patients had a completion within 20 minutes. The median time to completion was 12 minutes. The manual push is five minutes, so it really makes no difference. And 100% of the patients had a completion of the drug. So the device is really solid. It works; I mean, it never failed. So the material vigilance was very good. So we think that this new system is going to open the options for the patients. I believe everyone will move isatuximab to subcu with the OBI. I guess no one will stick to IV, but in exceptional patients. And then the question would be daratumumab subcutaneous manual push or isatuximab subcutaneous OBI. We’re going to have to learn the OBI, but I think it’s great. It’s a great technology. It’s really novel. And I hope, I believe, the patients and the teams, the nurses will love it. You could do it at home. The patient can go get the device and the isatuximab; they are given together at home, do it on their own; you almost don’t need a nurse anymore. So I think this is really like completely groundbreaking, really genius, really smart, very easy, and I hope it will help the patients, their families, and all the people who treat myeloma in the world.

This transcript is AI-generated. While we strive for accuracy, please verify this copy with the video.