FDA Greenlights Imetelstat in MDS: Key Insights From Dr. Sekeres

Mikkael A. Sekeres MD, MS, professor, medicine, chief, Division of Hematology, Leukemia Section, the University of Miami Health System, Sylvester Comprehensive Cancer Center, provides insight on the approval of imetelstat for treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia that requires at least 4 red blood cell units over 8 weeks who have not responded to, or have lost response to, or are ineligible for erythropoiesis-stimulating agents (ESAs).

The FDA approved imetelstat in this patient population on June 6, 2024, based on data from the IMerge/MDS3001 trial (NCT02598661).

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0:09 | For patients who have lower-risk, myelodysplastic syndromes, we do not have a lot of tools in our toolbox. We often, for somebody who has anemia, start with an erythropoiesis stimulating agent. That will work in somewhere between 20% and 40% of people, and it will work for on average about a year. When that stops working, we will turn to luspatercept [Reblozyl] or sometimes we will use luspatercept upfront. And again, that will work on average, [in] about 40% to 60% of people depending on when we use it and whether or not patients have ring sideroblast or an SF3B1 mutation. When that stops working, traditionally, we have turned to types of chemotherapy. With imetelstat, we have an option that comes between erythropoiesis stimulating agents and luspatercept, and something that I would consider to be more traditional chemotherapy like a hypomethylating agent.

1:19 | It is exciting to have another drug option that we can offer patients, and we need to keep working on it. We cannot rest on our laurels because we have 1 additional drug for patients with lower risk MDS. We need a lot of new drugs that we can try to keep people eventually living longer.