Geron Announces ASCO Presentation Reporting Durable Continuous Transfusion Independence with Imetelstat in IMerge Phase 3 Lower Risk MDS Patients

Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, announced a presentation reporting durable continuous transfusion independence with imetelstat, the Company’s first-in-class telomerase inhibitor, in IMerge Phase 3 lower risk MDS patients. These data were presented today at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.

“The presentation at ASCO of our IMerge Phase 3 data highlighted the meaningful longer-term duration of transfusion independence with imetelstat compared to placebo, as well as significantly higher rates of TI across MDS subgroups, greater reductions in transfusion units and sustained increases in hemoglobin levels,” said Faye Feller, M.D., Executive Vice President, Chief Medical Officer of Geron. “With our U.S. New Drug Application based on these data on track to be submitted to the FDA this month, I look forward to the day when imetelstat could be available for lower risk MDS patients in the first half of 2024.”

IMerge Phase 3 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 3 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. 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%).

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.