Yes, so my name’s Omali Pitiyarachchi, an oncologist in Australia. So what we did was we actually looked at the GCIG symptom benefit study from a different approach. And so particularly in platinum-resistant ovarian cancer, where, you know, over a decade or so, for over a decade, the median overall survival has stayed around 12 months or so. But just recently, we’ve had a few novel agents improve that progression-free survival and the overall survival...
Yes, so my name’s Omali Pitiyarachchi, an oncologist in Australia. So what we did was we actually looked at the GCIG symptom benefit study from a different approach. And so particularly in platinum-resistant ovarian cancer, where, you know, over a decade or so, for over a decade, the median overall survival has stayed around 12 months or so. But just recently, we’ve had a few novel agents improve that progression-free survival and the overall survival. So what we’re finding is that we need to find better markers or surrogate markers of overall survival in these diseases so that trials can really be read out earlier. And so when we analysed the symptom benefit study, and just to recall what that study was, that was enrolling patients with recurrent ovarian cancer, both platinum resistant and also potentially platinum sensitive. And these patients had received multiple lines of treatment. But in this session, what we focused on was the platinum-resistant cohort. And we wanted to see for those patients, for example, that were progression-free, did that actually indicate an earlier sort of indication of overall survival? So in order to do this, so a landmark analysis, we picked six months. So what that means is that at that point in time, we excluded patients that had either died or were lost to follow-up. And in those patients are alive at six months, we wanted to see those that were progression-free, i.e. no evidence of disease progression. Was there a difference in overall survival of those patients from that time point onwards compared to those patients that had evidence of disease progression? And what we found was there actually was, and it was actually quite statistically significant. So there was a difference in about 10.6 months or so between those two cohorts. And so this really means that, for example, with external validation, which we plan to do, we could potentially be using this surrogate endpoint in trials going forward. So that was the main finding in that, you know, what I presented at ESMO Asia. We also looked at, for example, you know, why six months? So we looked at different, you know, kind of time points. So, for example, is three-month progression-free survival also indicative or not? You know, what about four months? So we looked at time-dependent AUCs between three and 12 months for what it’s worth and found that actually of all those time points chosen, the time-dependent AUC was actually one of the highest at the six-month time point, but also it was quite stable after that as well, which means that, and we know that, you know, for example, in other trials, we use six months as a, you know, a landmark for, you know, analysing progression-free stages, et cetera. So it can be quite, you know, translated to trials quite easily. So not only did it make sense clinically, but also from a statistical point as well, it made sense to choose the six-month time point.
