Hi everyone, my name is Amr Zaydan. I'm a professor of medicine at Yale University and the chief of the Division of Hematologic Malignancies at Yale Cancer Center. I'm speaking to you from Milan, where we are here for the European Hematology Association meeting, and it's a very, very exciting meeting with a lot of developments. I focus on MDS and AML, and I think one of the most exciting kind of evolving stories with acute myeloid leukemia is the MEN inhibitor story. We are presenting some data from the Zephtomineb studies, so there are a number of these MEN inhibitors. All of them primarily work in patients who have MPM1 or KMT2A rearranged leukemia, and I think the data that has been generated by the MEN inhibitor is very important. The data that has been generated with all of the MEN inhibitors have so far been quite exciting. We are seeing responses, and those responses can last several months in patients who have very refractory disease after venetoclax failure in patients post-transplanter labs, which are very difficult kind of settings to treat patients on. But I think what is quite exciting to me is the potential of combining these drugs with our standard of care approaches with intensive chemotherapy and ACEVN. So we are presenting data from the COMET 007 study, the combination study where I'm the senior author. The study is looking at adding Zephtomineb to 7 plus 3, and we are updating the data that was presented in ASH 2024. At ASH we talked about 40 patients. Now we are talking about more than 80 patients, where we continue to show very high rates of complete remission with the combination. We show that many of those patients achieve MRD negativity, which generally is a surrogate for kind of long-term survival. We also show that the combination is well tolerated. There is very low rate of QTC prolongation or differentiation syndrome or added myelosuppression with Zephtomineb. I think overall the data is very encouraging, and it allowed us to move actually to the registrational approach using the COMET 0017 study for the combination approach. And in this meeting as well, we are actually presenting the trial in progress abstract, looking at adding Zephtomineb to 7 plus 3 or ACEVN. Two studies basically in the same protocol based on the fitness of the patient. So for fit patients, 7 plus 3 versus 7 plus 3 was Zephtomineb. In non-fit patients, ACEVN versus ACEVN Zephtomineb. And those trials are going to aim for registration. It's going to be large international, many center kind of study. And the primary endpoint for the intensive chemo study is going to be MRD negative CR plus EFS, while for the on-patients going to be CR plus OS, overall survival. So I'm very excited about these studies and hopefully they will get started soon because I think this is where we are going to see the full benefit of Zephtomineb. And I think it's a very exciting field to be with all these active drugs that we are seeing in acute myeloid leukemia. Thank you.
HealthTree • July 14, 2025