- New analyses from IMerge Phase 3 reported higher 24-week transfusion independence (TI) responses for imetelstat-treated patients vs. placebo across key myelodysplastic syndromes (MDS) subgroups and across spectrum of MDS mutations
- New data and analyses indicated greater variant allele frequency (VAF) reductions for imetelstat-treated patients vs. placebo across multiple genes commonly mutated in MDS; these reductions also were correlated with clinical endpoints of TI response, longer TI duration and increase in hemoglobin levels, providing further evidence of disease-modifying activity of imetelstat
- First data on patient-reported outcomes (PRO) described a sustained meaningful improvement in fatigue for imetelstat-treated patients vs. placebo
- Data support NDA submission, which is on track for June 2023 to support potential U.S. commercial launch in first half of 2024
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced new data and analyses from IMerge Phase 3 reporting robust durability of transfusion independence (TI), evidence for disease-modifying activity and favorable fatigue patient-reported outcomes (PRO) in lower risk myelodysplastic syndromes (MDS) patients treated with the Company’s first-in-class telomerase inhibitor, imetelstat, vs. placebo. The data and analyses were presented at the European Hematology Association (EHA) Annual Meeting, which took place from June 8-11, 2023 in Frankfurt, Germany and virtually.
“The new IMerge Phase 3 data and analyses presented at EHA continue to support the unprecedented and differentiating attributes of imetelstat, including 24-week transfusion independence across key MDS subgroups, potential disease-modifying activity, as well as favorable patient-reported outcomes (PRO) data on meaningful improvement in fatigue,” said Faye Feller, M.D., Executive Vice President, Chief Medical Officer of Geron. “Each of these qualities address important unmet needs for lower risk MDS patients due to the limitation of current treatment options. Submission of our New Drug Application later this month is a significant step to hopefully bring imetelstat to these transfusion burdened patients.”
Presentation Title: Continuous Transfusion Independence with Imetelstat in Heavily Transfused Non-Del(5q) Lower Risk Myelodysplastic Syndromes Relapsed/Refractory to Erythropoiesis Stimulating Agents in IMerge Phase 3
Top-line results from the primary analysis of IMerge Phase 3 presented earlier this month at the 2023 American Society of Hematology (ASCO) Annual Meeting were also covered in the EHA presentation, including the primary endpoint of 8-week transfusion independence (TI) and key secondary endpoint of 24-week TI were met with high statistical significance (P