VALIDATE Database Results to Inform MDS Management | David Sallman, MD | ASH 2023

My name is David Solomon from Moffitt Cancer Center in Tampa, Florida, and again at the ASH 2023 Congress. I'm part of a very large group called Validate, which is a multi-country and international consortium where we are looking at very big and central questions in the management of the disease. And trying to truly identify and validate, for example, response criteria, outcomes in certain patient populations to really give us the best historical subset when we're looking at new therapies and are we doing better or are we not doing better than historical? I think when we have really small cohorts, this can be actually very challenging and you get sometimes controversial or conflicting data. And so one thing that I'd like to highlight is when we think about what response we're trying to achieve in patients, we don't just want blast clearance. This is called a merocomplete remission, and we've actually eliminated that from the response criteria. But what we really want to see is either true complete remissions where all blood counts are really back to a more normal range or at least blast clearance with some level of hematopoietic recovery. And thus there are what we call composite complete remissions where we look at both true complete remission as well as true complete remission with some other, again, sort of in between response we can call the CRH or CRL. And what we really nicely show is patients that achieve that response have really identical outcomes to patients with true complete remission and much better outcomes than patients with any other response. So I think when we go forward and hey, what is really exciting in any area of MDS, particularly I would say in the high risk setting, if we can achieve, again, complete remission or again, a marrow response where we get blood count improvement, again, what we call CRH or CRL, then that is really what will be most meaningful. And then based on those data, if those data are exciting again versus historical data, potentially would best support what trial should next go into the pivotal phase. And I expect to see a lot more data coming out of this consortium. There was actually six abstracts at this Congress looking at different things, but that is just highlighting one of sort of a key question that I think was answered at this Congress.