My name is Nisha Joseph.
I'm one of the myeloma physicians at Emory Winship in Atlanta, Georgia.
And one of the posters that we're presenting, our group is presenting, at ASH, here is looking at iberdomide, which is a novel CELMoD in the treatment of both intermediate and high risk smoldering myeloma as defined by the 20-2-20 criteria.
The design of the trial is really based off of the ECOG-E3A06 trial, which was run by Doctor Lonial, at our institution, which looked at lenalidomide in high risk smoldering myeloma patients versus observation.
And lenalidomide was continued until progression.
And in that trial, the three year progression free survival was 91% versus 66%, favoring len.
And the benefit was most pronounced for the high risk patients specifically when you looked at high risk by Mayo 2018 or 20-2-20 criteria.
So that was a really impressive PSF benefit.
There was a relatively high rate of treatment discontinuation and adverse event rate, and the median time on therapy was 23 months.
So for that reason, the authors concluded that it made sense to give patients lenalidomide but kept it at two years, so you get that whole sleep progression free survival benefit without that additive toxicity.
So this trial was really kind of built upon that design and upon that recommendation.
And we're using iberdomide, which is a novel CELMoD.
And the idea is that this drug is more potent than lenalidomide when we look at it in clinical trials in the relapsed refractory myeloma space, and it's better tolerated.
So can we use an even more potent, better tolerated drug in an otherwise asymptomatic patient population and try to get them that benefit.
And so there was an initial safety run in looking at two doses.
There were no deal to use at that time.
We did end up going forward with the lower dose because there was less neutropenia.
And again, we're trying to keep these folks feeling asymptomatic.
And we've randomized patients were then randomized to either iberdomide or iberdomide with dexamethasone low dose for four cycles to see if we can get an additive efficacy benefit.
And there's also some immunologic correlates we're looking at as well.
So we've enrolled about a third of the study 21 patients.
Overall response rate is around 80% a little higher in patients who received dexamethasone.
Overall quite early.
We only have three patients and follow up.
But I think very promising.
We seeing a lot of, new, more novel therapies using smoldering myeloma that are seeing even higher response rates and that higher rates of MRD negativity, which is also very exciting.
But I would just point out in the ECOG-E3A06 trial, the overall response rate was 50% and we still saw a significant benefit, very similar even to what we saw at the three year mark in more curative trials, like, the central at the jumps, our trial.
So really question do we need that that depth of response.
And perhaps we do.
But I think we need more time to see that.
So overall we're very excited about these results.
And I think also importantly, the drug is very well tolerated in smoldering myeloma and outside of neutropenia, which we've managed to mitigate.
And with dose reductions, patients are doing really well.
So we're very excited about the data and look forward to continue to enroll.
HealthTree • January 21, 2025