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COMy 2020 | Outcomes of IRd in R/R multiple myeloma in routine clinical practice

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Xavier Leleu

Xavier Leleu, MD, PhD, Poitiers University Hospital, Poitiers, France, discusses the outcomes in relapsed/refractory multiple myeloma patients treated with ixazomib in combination with lenalidomide and dexamethasone (IRd) in routine clinical practice. The outcomes observed in the real-world setting were comparable with the original clinical study, TOURMALINE-MM1 (NCT01564537). In routine clinical practice, the patients were older, frailer and had comorbidities. This is very promising in light of getting approved and reimbursed by European governments. This interview took place during the Controversies in Multiple Myeloma (COMy) 2020 Virtual World Congress.

Transcript (edited for clarity)

Years ago in the relapse setting, four combinations lenalidomide-based were approved: daratumumab, carfilzomib, ixazomib, and elotuzamab, in combination with lenalidomide and dexamethasone. There was one combination that was of particular interest across the full combination that spoke about. That combination is the ixazomib, revlimid, dexamethasone. Why is that? It’s because that combination is the only entirely oral triplet based combinations where ixazomib, a proteasome inhibitor, a key family in myeloma, particularly in the relapse setting, is given orally only three uptakes a month...

Years ago in the relapse setting, four combinations lenalidomide-based were approved: daratumumab, carfilzomib, ixazomib, and elotuzamab, in combination with lenalidomide and dexamethasone. There was one combination that was of particular interest across the full combination that spoke about. That combination is the ixazomib, revlimid, dexamethasone. Why is that? It’s because that combination is the only entirely oral triplet based combinations where ixazomib, a proteasome inhibitor, a key family in myeloma, particularly in the relapse setting, is given orally only three uptakes a month. Once one, eight, fifteen, revlimid is given orally one capsule a day, for three weeks on, one week off, in general, and dexamethasone on a weekly basis with ixaxomib, in general. So, it’s the only existing triplet based combinations. And in high-risk myeloma patients, it appeared in the early relapse setting to be as good as the other combinations, in standard risk it appeared to be probably not as interesting as carfilzomib, daratumumab but close enough.

And so, the very important aspect of the discussion here was, we know in clinical trials, patients are selected, biased, in highly biased, in the way they are selected because we always pick the “best patients” for clinical trials and only the “best patients” accept to recruit into clinical trials. But what about the real life? And it’s important to look into the real life because we have very rapidly figured out that in real life, we would particularly be giving Ixa/Rev/Dex to more advanced patients in terms of age. And also in terms of frailty and comorbidities. And so, what the data speaks to from those various observatory registries that have looked at Ixa/Rev/Dex in the real life was that yes, it’s confirmed that Ixa/Rev/Dex, I/Rev/Dex is given often to a bit more advanced elderly patients. It’s proved that the data we have in terms of efficacy, response, depth of response, survival, survival to the next line, or overall survival is very similar in the real life as it was in the clinical trials.

Although the patients are slightly older, slightly more frail, having slightly more comorbidities. So, it’s becoming a very important topic. And Takeda with ixazomib has kind of pioneered in the field, the idea that in the future in Europe, for European countries, it is going to be extremely important that the company get approved and get the drug reimbursed at a given price, based on clinical trials data. However, it is expected that governments will review the price and the scientific scoring based, after the approval and reimbursement, on how in the real life the drug will perform, not just in clinical trials where we know the patients are biased and selected in the way they are recruited.

And so, it’s interesting to see that if we now pick Ixa/Rev/Dex particular interest to this combination, it seemed that the real life data were absolutely superimposable to the clinical trial data. And, in that regard, I would say we would expect then that governments would be very pleased to see that, despite the selection of the clinical trials recruitment, real life is exactly the same. And so Ixa/Rev/Dex is a very interesting compound, interesting combinations, particularly in the case of patients that don’t want to come to the hospital to get infusions or subcutaneous drug, and would love to stay at home, getting their treatment and myeloma control at home.

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