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EHA 2026 | The benefits and potential of the isatuximab on-body injector in multiple myeloma
In this interview, Xavier Leleu, MD, PhD, Poitiers University Hospital, Poitiers, France, discusses the benefits and potential of the isatuximab on-body injector (OBI) device in multiple myeloma (MM), highlighting the encouraging safety of this novel mode of administration in clinical trials. The OBI results in a significant reduction in infusion reactions and local reactions compared with intravenous or subcutaneous ‘manual push’ administration, and Prof. Leleu believes that this device could be used at home by patients to reduce the logistical burden and treatment costs. This interview took place at the 31st Congress of the European Hematology Association (EHA) in Stockholm, Sweden.
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Transcript
Based on the IRAKLIA data that were very impressive in regards to the OBI on-body injector infuse device to offer a new subcutaneous formulation way to patients and here with Isatuximab, a CD38 antibody, we thought that we needed to now consolidate that data with a much greater population, more patients to consolidate the data because the results were very, very impressive and I’ll get to that in a minute...
Based on the IRAKLIA data that were very impressive in regards to the OBI on-body injector infuse device to offer a new subcutaneous formulation way to patients and here with Isatuximab, a CD38 antibody, we thought that we needed to now consolidate that data with a much greater population, more patients to consolidate the data because the results were very, very impressive and I’ll get to that in a minute. So we combined IRAKLIA, which was a relapsing Isatuximab subcutaneous with Pom-Dex, to IZALCO, that was Isatuximab carfilzomib-dex up front, with a phase one study. The three studies together offered a great number of patients, more than 6,000 injections, a couple of hundred, several hundred patients with myeloma.
And so we have been looking at the data we captured with IRAKLIA. Number one, in terms of safety, how many times the patient had an infusion reaction. When you get an antibody, a vaccine, an immunotherapy, anything for the first time injected in your body, you will have a systemic infusion reaction, immunoallergic reaction. And how many times? Because when it’s IV, it’s about 25% of the patients. When it’s regular manual push, it’s between 5% and 10% of the patients. But in IRAKLIA, it was less than 1% in infusion, less than 1% of the patients. And so with the pooled analysis of the database we’ve had, we confirmed that less than 1% of the infusion, approximately 1% of the patients may have an infusion reaction, most of the time, the vast majority of the time, grade one. So this is not just data. That’s a practical importance. Practical importance is that today when I treat a patient IV, I hospitalize the patient overnight. When I give a subcutaneous formulation manual push, I keep the patient hours after the first injection. I believe Isatuximab with the OBI, you don’t have to keep the patient in the outpatient clinic for a couple of hours after injection, given that less than 1% of the infusion and less than 1% of the patient will have infusion reaction. Point number one.
Point number two, local reaction. With many subcutaneous formulations, there is a product mixed to the immunotherapy, and the local reaction can be problematic. I have patients, after the first injection, they have a local reaction. After the second injection, they have a local reaction. And they keep having local reactions that don’t entirely recover. It could be painful. It could be dangerous for the skin and the subcutaneous tissue of the patients. With the OBI, because of the very tiny gauge of the needle, because Isatuximab doesn’t have hyaluronidase combined to it, we confirmed in that study, again, more than 6,000 injections, hundreds of patients, we confirmed that the risk of the local reaction was absolutely minimal. Less than 1% of the infusion, less than 5% of the patients.
On top of that, we also need to validate that the device works. And we confirmed that the median time to injection is between 10 to 12 minutes. In a subcutaneous manual push, it’s five. So it really makes no difference. We also confirm that 99% of the time, the injection was completed right within maximum 20 minutes. So the device is very safe. Not only the injection, but the device is safe.
So altogether, practically, what does that mean? It means that I believe Isatuximab with the OBI can be given at home. It means that you need to train and educate the patient initially. But thereafter, I’m pretty sure most of my patients can manage that on their own. No nurse, no pharmacist, no team in trouble because too many patients, too much work, and probably, I hope, a decrease in cost in the end. Because if you can treat patients at home, you save money on transportation. If you can have less nursing, less pharmacist implication, you save money on the nursing and the pharmacist implication. So I even think that in the end, it might be cost-effective for the patients, for the countries. So I think it’s an amazing innovation. And I’m very happy that I’ve been part of that innovation. I’ve been lucky enough to discover that we could be smart enough, the human beings, for inventing such things.
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