Hi. I'm Betsy O'Donnell from the Dana-Farber Cancer Institute.
Today I'm going to be talking about an ad hoc analysis that we did of our SKylaRk study, which is a phase two prospective study of isatuximab, carfilzomib, lenalidomide and dexamethasone in newly diagnosed transplant eligible patients with multiple myeloma.
And one of the interesting aspects of this clinical trial, which was highly efficacious, was that 88% of patients opted to defer transplant.
And so one of the questions we asked ourselves is what happens if patients defer transplant?
Do we see the same types of benefit, particularly as the longer term data starts to come back?
And so what's nice about the state I think we learned two important things.
For standard risk patient are progression free survival was excellent and held up against all of the other clinical trials which incorporated transplant.
We had very small numbers and patients who had to like a double hit, extremely high risk myeloma.
It's only about five patients, but that is the place where we saw perhaps there was a benefit to transplant when we compared ourselves.
You're never supposed to compare across trials, but of course we all do, because we're really trying to get to the best answers for patients.
And so in that very small subset of what we would call a double head myeloma, it did appear that our progression free survival was lower than that compared to some of the other trials that incorporated transplant.
So it's something to think about in our clinical practice in terms of whether or not we need to incorporate transplant.
Arguing that for standard risk patients and for even some high risk patients, that may be a therapy that we can defer potentially.
But for some of those high risk patients and super high risk patients, we might want to consider, the ongoing incorporation.
In multiple myeloma, when you have that bone marrow biopsy, we do it for two reasons.
One, to quantify the number of plasma cells, and then also to look at the quality of those cells.
And so we know that anything that is neoplastic or abnormal has certain mutations.
But there are some that we have defined as being higher risk for adverse outcomes than others.
So we have standard risk.
And then we have high risk which include things like deletion 17 translations for 4;14, 14;16, 14;20 and 1q duplication and amplification.
And so these are for, you know, very minutia.
But having one is a high risk factor.
Having two is what we call two of these high risk mutations would be that double hit that we're referring to.