Dr Enrique Ocio Discusses the Advantages of Sub-Q Isatuximab for RRMM

Enrique Ocio, MD, PhD, hematology department head, Marqués de Valdecilla University Hospital, Santander, Spain, discusses phase 1b trial results for subcutaneous (sub-Q) vs intravenous isatuximab, both formulations administered in combination with pomalidomide and dexamethasone for relapsed/refractory multiple myeloma (RRMM).

He is coauthor of the abstract “Subcutaneous (SC) Isatuximab Administration by an On-Body Delivery System (OBDS) in Combination With Pomalidomide-Dexamethasone (Pd) in Patients With Relapsed/Refractory Multiple Myeloma (RRMM): Interim Phase 1b Study Results,” presented today during the American Society of Clinical Oncology (ASCO) annual meeting.

Transcript

Can you discuss your study findings that show sub-Q isatuximab is safe and effective for use in RRMM?

This was a phase 1b study that evaluated the activity of isatuximab, pomalidomide, and dexamethasone in patients with relapsed/refractory myeloma. In this phase 1b [study], there were different methods of administration. We started with an IV [intravenous] formulation and then moved to a sub-Q [subcutaneous], and the subsequent patients received a sub-Q administration of isatuximab, with 2 doses at 100 mg per dose, and then we went to 1000 mg and 1400 mg. Then at the end, more than 20 patients received the sub-Q administration of isatuximab by using an OBDS, a specific on-body delivery system device.

I think the main message of the study is that the combination is active in these patients with relapsed/refractory myeloma, with a response rate around 70% to 80%, and it’s safe and in fact is quite convenient for patients. This was the main message of the trial. Also, we can say that higher doses seem to be a bit more active with the 1400 mg in combination with pomalidomide and dexamethasone and also with the feasibility of using this on-body delivery system that I think is also an advantage for these patients.

Will the 1400-mg dose be the study dose going forward?

This was the recommended dose for the study; the 1400 mg was the planned dose for those coming from the 1000 mg, or 1 g, so I think this would be the recommended dose going forward.

Did the study collect PROs for this method of administration? What were the general findings?

There are questionnaires for PROs [patient-reported outcomes] for patients. I don’t have the data of the questionnaires, I don’t know if they are already analyzed, but definitely I have to say that our patients are really comfortable with this system. It is quite convenient for them also, it is very important. Once we have seen that the efficacy is similar or it’s maintained, we need to see the safety and, of course, there’s the convenience and having a device or a way of just in 10 minutes you can have the drug administered quite safely without any adverse events, even without infusion-related reactions. So I think this is very convenient for patients.

Is sub-Q isatuximab also convenient for cancer centers and clinicians?

Of course. This is also convenient for us, as we have such a tight schedule. You have so many patients, so having a device that is quick and fast with delivery and administration gives us more time for other patients. And it’s very convenient because it’s also very easy to use. It even can be used by the patients on their own. But of course in our centers, it’s given by the nurses. This is really convenient for all the people involved in the trial.

What are the next steps for sub-Q administration of isatuximab?

For the sub-Q administration of isatuximab, we need to confirm these data—here we have 30 patients treated with the sub-Q formulation. We have to confirm these data in other studies and other combinations. And at the end, sub-Q would be the way to go; it would be the way of administration that would be approved in the future for isatuximab, which is very important.

Also, then we will have the OBDS device that has to be approved and confirmed. Again, I think this should be the way to administer isatuximab. We could even think in the future that in patients this could be administered at home, not only in the hospital or in the medical centers. But even with that, it could be administered very easily at home to patients in 10 minutes. Very easily by nurses and or even by the patients, we could think of that in the future. We have to change something, but this would be also interesting.

I want to add that this is one of the combinations that have demonstrated activity with isatuximab, pomalidomide, and dexamethasone in this relapsed/refractory patient population, with a good schedule of administration. Patients are really responding. From my point of view, and from my patients’, they are responding very well. The ability [to respond] is very good for this for this combination. It’s good to have it, this isatuximab anti-CD38 monoclonal antibody, to be ready in different combinations for our patients.