ASH 2024 | HRQoL in patients receiving Isa-VRd versus VRd alone in the IMROZ trial

In the field of the newly diagnosed myeloma transplant ineligible, usually patients older than 65 and up to 80, potentially 80 plus years old. There has been this year in 2024 a new definition of a new standard of care which is groundbreaking, a quadruplet-based regimen based on a couple of studies, Phase III studies, two of them for registration, and one study that I’m talking about now is IMROZ. So as you pointed out, as you just said, IMROZ is a comparison, one to one, between two regimens, an old standard of care, VRD, Bortezomib, Lenalidomide, Dexamethasone, and a new standard of care, the quadruplet-based regimen. The real novelty here is that you take the same control arm, the backbone VRD, and you add a CD38 monoclonal antibody. 

The quadruplet-based regimen in the original data presented at ASCO, and EHA 2024, published now in New England Medicine in June 2024, demonstrated how incredible the quadruplet was, not only better but so much better based on the primary endpoint, the PFS, with a hazard ratio 0.59 and a control arm that performed incredibly well, 54 months, almost 10 to 12 months better than we used to. And with this hazard ratio and expectation of this experimental arm, PFS median around 80 or 90 months, almost what we were used to get five, ten years ago in the transplant setting, although now here we are in the non-transplant setting. 

The second probably most interesting, most important data was the MRD negativity rate, the sustained MRD negativity rate at 10 to minus 5, 10 to minus 6. All of these data were so incredibly increased. The control arm was about 40 percent and the study arm was almost at 60 percent, a 20 percent increase. Again, incredible. 

Now, what’s very important is that when you and what’s important for the patients, their families, and for all the people that are going to use that regimen, that quadruplet-based regimen, is that the patients are going to do good, they’re going to survive for a very long period of time, so we are going to have to learn how to give it safely to the patients, and it’s not like giving a drug for one year, you’re talking about giving a drug for almost eight to ten years, and you’re talking about giving four drugs, then at some point two drugs for eight to ten years, and so it’s very important to look deeply into the safety profile and the quality of life of the patients, so to make sure that if they survive with myeloma but then they survive with a good quality of life, and they are happy surviving with myeloma. 

So the sponsor Sanofi, has been doing an analysis of the quality of life in IMROZ to look into whether the patients that are going to be the longest on treatment because they survive longer because their regimen is much better are going to benefit from their treatment not only in terms of disease control but also in terms of quality of life. So the IMROZ study reported after five years follow-up, which is a very long follow-up, usually the studies report after two or three years, and here it’s five years median follow-up, reported that the quality of life of the patients on the quadruplet-based regimen was absolutely superimposable to the triplet-based regimen. So this is very interesting because it tells that the addition of the CD38 monoclonal antibody, isatuximab, actually improved the chance for the patient to survive and never compromised their quality of life, the rate of side effects, the severity of the side effects, and how the side effects could pollute or impair the quality of life. So it’s very reassuring. It shows the regimen is safe. It should, I think, I believe, encourage every colleague to propose the treatment to their patients.

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