"Statistically significant and clinically meaningful efficacy results [were] achieved across key MDS subgroups: ring sideroblast status, baseline transfusion burden and IPSS risk category," the company said in a statement. "Safety results [were] consistent with prior imetelstat clinical experience."


The data supports plans to submit New Drug Application to the US Food and Drug Administration in June this year, Marketing Authorization Application in the European Union in H2 2023 and a potential US commercial launch in H1 2024.


"The IMerge Phase 3 results are especially encouraging because of the significant unmet need in lower risk MDS patients with symptomatic anemia needing regular red blood cell transfusions," said Amer Methqal Zeidan, lead investigator and director of hematology early therapy research at Yale University.


The findings were presented Friday at the American Society of Clinical Oncology's annual meeting in Chicago.