Dr. Susan Galbraith
👤 PersonAppearances Over Time
Podcast Appearances
The debate really is about the safety profile of the two, because there are adverse events that come from the anthracycline containing regimen, which should determine some of those choices.
So I think it's well established that it's an even efficacy bar, regardless of which regimen you choose.
And then in terms of the safety profile, there are different safety events that you see with one regimen or the other.
Comparing with either of those historical regimens in terms of the safety profile of INHER2 for the four cycles in Destiny Breast 11, I think the general feedback that we're getting is that it clearly seemed to be an overall better tolerated regimen than either of those two previous accepted regimens and with good
outcomes on not just the pathologic complete response rate, but as I say, that early trend to improvement in event-free survival, although it's immature and clearly not statistically significant at the current point, will start to be a robust status there.
And again, I think people are looking at the overall
efficacy for INHER2 with the totality of data across the Destiny Breast 11 and the Destiny Breast 05 data set.
So I don't think that anybody is feeling that there needs to be another study comparing with TCT-HB in order to make the decision as well.
So just to be really clear, depending on which is what's called the preferred term that gets entered into the electronic data record, it could be either pneumonitis or ILD.
Then there's an adjudication committee that determines whether or not, taking into account all of these, there's an expert committee that view whether this is a drug-related ILD event, but they're using that terminology.
depending on either of the codings that are actually put in there.
So the rate that we saw is an adjudicated rate.
And again, in the DB11 data set was a lower rate actually that was seen on the control arm, you know, similar, but just numerically slightly lower.
So, you know,
I don't think there's a major issue about splitting those two out.
In terms of the long-term side effects, of course, there was one fatal event on both arms.
You know, so that's the first one.
Of the remaining events that were seen, the vast majority of these have fully resolved.
So, you know, I think, you know, again, with the four...
dose regimen, relatively short exposure in this early stage setting.