Geron Announces Data Presentations from IMerge Phase 3 Evaluating Imetelstat in Lower Risk MDS at Society of Hematologic Oncology Annual Meeting

Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced poster presentations of data from IMerge, the Company’s Phase 3 clinical trial evaluating its first-in-class investigational telomerase inhibitor imetelstat vs. placebo in patients with lower risk myelodysplastic syndromes (MDS) at the eleventh annual Society of Hematologic Oncology Annual Meeting (SOHO) held in Houston, Texas and virtually.

“For imetelstat-treated patients in the IMerge Phase 3 trial, the durability of transfusion independence, substantial increases in hemoglobin, robust treatment effect across subgroups and improvement in fatigue, along with a manageable safety profile, represent, we believe, an unparalleled clinical benefit in lower risk MDS,” said Faye Feller, M.D., Executive Vice President, Chief Medical Officer of Geron. “It was particularly meaningful for these data to be presented at SOHO, where there was a broad array of professionals who touch the lives of patients with lower risk MDS.”

The following posters presented at SOHO reflected data presented at the European Hematology Association annual meeting in June 2023:

• MDS-572: Continuous Transfusion Independence with Imetelstat in Heavily Transfused Non-Del(5q) Lower-Risk Myelodysplastic Neoplasms Relapsed/Refractory/Ineligible for Erythropoiesis-Stimulating Agents in IMerge Phase III
• MDS-604: Improvement of Patient-Reported Fatigue in IMerge Phase III Trial of Imetelstat vs Placebo in Heavily Transfused Non-Del(5q) Lower-Risk Myelodysplastic Neoplasms Relapsed/Refractory/Ineligible for Erythropoiesis-Stimulating Agents
• MDS-605: Disease Modifying Activity of Imetelstat in Patients with Heavily Transfused Non-Del(5q) Lower-Risk Myelodysplastic Neoplasms Relapsed/Refractory/Ineligible for Erythropoiesis-Stimulating Agents in IMerge Phase III

The posters are available under the Publications section of Geron’s website: https://www.geron.com/research-and-development/publications/.

As previously reported, in the IMerge Phase 3 clinical trial, the primary endpoint of 8-week transfusion independence (TI) was significantly higher with imetelstat vs. placebo (p<0.001), with median TI duration approaching one year for imetelstat 8-week TI responders. Mean hemoglobin levels in imetelstat-treated patients increased significantly (p<0.001) over time compared to placebo patients. Statistically significant and clinically meaningful efficacy results were achieved across key MDS subgroups irrespective of ring sideroblast (RS) status, baseline transfusion burden and IPSS risk category. Patient-reported outcomes (PRO) data reported a sustained meaningful improvement in fatigue for imetelstat-treated patients vs. placebo. Consistent with prior imetelstat clinical experience, the most common serious adverse events were primarily short-lived, manageable cytopenias. Treatment with imetelstat vs. placebo led to greater reduction in variant allele frequency (VAF) in multiple genes associated with lower risk MDS, which correlated with clinical endpoints of TI response, longer TI duration and increase in hemoglobin levels, suggesting the potential of imetelstat to modify the disease.