IMerge phase III trial of GRN 163L in myelodysplastic syndromes patients meets primary endpoint.- Geron Corp
Geron Corporation announced a presentation reporting durable continuous transfusion independence with GRN 163L (imetelstat), the Company’s first-in-class telomerase inhibitor, in IMerge Phase III lower risk MDS patients. These data were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.
IMerge Phase III enrolled lower risk MDS patients who were relapsed after, refractory to, or ineligible for erythropoiesis stimulating agent (ESA) treatment and were transfusion dependent, defined as requiring at least four units of packed red blood cells (RBCs) over an eight-week period. The ASCO presentation reported IMerge Phase III results with a data cut-off of October 2022, the same for top-line results reported in January 2023. The primary endpoint of 8-week transfusion independence (TI) was met with high statistical significance (P<0.001) for imetelstat-treated patients (39.8%) vs. placebo (15.0%). of the imetelstat 8-week responders, 83% had a single continuous ti period. highly statistically significant (p><0.001; hazard ratio 0.23) durable transfusion independence for 8-week ti responders was achieved with a median ti duration approaching one year for imetelstat, compared to approximately 13 weeks for placebo.></0.001;></0.001)>
The key secondary endpoint of 24-week TI was also met with high statistical significance (P<0.001) for imetelstat-treated patients (28.0%) vs. placebo (3.3%).></0.001)>
Mean hemoglobin levels in imetelstat-treated patients increased significantly (P<0.001) over time compared to placebo patients. for patients achieving 8-week ti, median increases in hemoglobin were 3.6 g dl for imetelstat and 0.8 g dl for placebo. imetelstat-treated patients also experienced a statistically significant (p="0.042)" and clinically meaningful mean reduction in rbc transfusion units compared to placebo. a highly statistically significant (p><0.001) hematologic improvement-erythroid (hi-e) rate was achieved for imetelstat (42.4%) versus placebo (13.3%) using the iwg 2018 criteria for hi-e.></0.001)></0.001)>
Significantly higher 8-week TI rates were observed with imetelstat vs. placebo across key lower risk MDS subgroups, including ring sideroblast (RS) status, baseline transfusion burden and IPSS risk category, with similar 8-week TI responses seen for imetelstat within each subgroup category. The safety profile observed with imetelstat in IMerge Phase III was consistent with prior clinical experience with no new safety signals. Non-hematologic adverse events (AEs) were generally low grade.
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