Geron reports Phase II data of imetelstat for MDS

Geron Corp. (NASDAQ:GERN) said IV imetelstat (JNJ-63935937, GRN163L) led to a rate of red blood cell (RBC) transfusion-independence for at least eight weeks, the primary endpoint, of 38%. The data were from the first 32 patients with low or intermediate-1 risk myelodysplastic syndrome (MDS) that is relapsed or refractory to erythropoiesis-stimulating agents (ESAs) in the open-label Phase II portion of the Phase II/III IMerge trial. At a median follow-up of 66.1 weeks, imetelstat led to a mean relative reduction in transfusion burden from baseline of 64%. Imetelstat also led to a rate of RBC transfusion-independence for at least 24 weeks, a secondary endpoint, of 16%.

In a subgroup of 13 patients who were naïve to Revlimid lenalidomide and hypomethylating agents and who lacked a 5q chromosomal deletion, imetelstat led to rates of RBC transfusion-independence for at least eight and 24 weeks of 54% and 31%, respectively. Additionally, imetelstat led to a mean relative reduction in transfusion burden from baseline of 71%. Based on the subgroup data, Geron said the trial protocol has been amended to only include patients who meet the subgroup criteria. Data were presented at the American Society of Hematology meeting in Atlanta in December...