Hi, my name is David Swaboda. I'm the Director of Leukemia at Tampa General Hospital Cancer Institute. And I'm excited to talk about some of the ongoing updates at the American Society of Hematology Conference. This year was a big year for MDS with two phase three studies being presented at ASCO, including the COMMANDS trial, which is loose batter subverse ESA in the front line setting, showing twice the risk transfusion independence rate at eight weeks, as well as durable transfusion independence. Updates that trial are being presented at ASH, specifically focusing on important subgroups. Additionally, another phase three study was presented at ASCO, which is the iMERGE study that's on imetastat. And ultimately, it showed in the ESA, the patients that are post ESA, that they had about a 40% transfusion independence rate compared to about 15% in placebo. That data is also being presented again at ASH with some important updates. But these are both potential practice changing, very clinically meaningful presentations that the MDS community is really excited about and getting updates and further diving into the granularity of the data. Additionally to that, there's a lot of good combination studies specifically focused on high risk patients in myelodysplastic syndrome. So you know, Venetoclax, which is a BCL2 inhibitor used right now in FDA approved in acute myeloid leukemia for elderly or unfit patients, is now being brought into the MDS space. And because MDS is characterized by dysfunction of the marrow, which is the dysplasia piece, we do deal with more cytopenias, low blood counts with this particular combination. And thus we have made the decision to actually have a reduced dose of the Venetoclax. Ultimately, the large phase two data is being presented by Jacqueline Garcia. And that has led to an ongoing trial, clinical trial called the Verona trial. And everyone in the MDS community is eagerly awaiting the data there. Thinking about MDS, the immune system is an area that is under a lot of interest and a lot of exploration. And so the MDS community was really excited about the combination of Vidaesa plus McGrollumab, which is a CD47 inhibitor that allows macrophages, which is immune cell of the body, to basically eat the cancer cells. So we had ongoing phase three clinical trials. The unfortunate part was that that particular clinical trial actually was ended early for futility. So now a lot of investigators are looking for other immune based options where we can basically ramp up patients own immune system to attack the cancer, similar to what we do in solid tumors and other hemolymphencies. And so there's a couple of important abstracts being presented, looking at different targets. So CD123, which is on the cancer cell as a target. So we're excited about the combinations of a CD23 CD3 bispecific T cell engager that has shown at least a signal for increased response rates in the MDS patients that have failed hypomethylating agents in the past, as well as other novel immune agents that are still early, but a lot of presentations. And the hope is that over the next year or so, we will find an agent, find a combination that ultimately leads to an FDA approval to really not only just use traditional chemotherapy for high risk disease and transplant, but also to add in immune therapy to better control the disease and potentially have more durable remissions. So that's a quick summary of some of the existing data, recent FDA approvals, and some of the things that MDS investigators are most excited about at ASH. And yeah, look forward to additional updates.
HealthTree • December 20, 2023