On September 7, 2023 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported 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 (Press release, Geron, SEP 7, 2023, View Source [SID1234634988]).
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"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 (EHA) (Free EHA Whitepaper) 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: View Source
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.
Based on results from the IMerge Phase 3 clinical trial, Geron submitted a New Drug Application for imetelstat in lower risk MDS that was accepted for review by the FDA and assigned a Prescription Drug User Fee Act (PDUFA) action date of June 16, 2024.
About IMerge Phase 3
The Phase 3 portion of the IMerge Phase 2/3 study is a double-blind, 2:1 randomized, placebo-controlled clinical trial to evaluate imetelstat in patients with IPSS Low or Intermediate-1 risk (lower risk) transfusion dependent MDS who were relapsed after, refractory to, or ineligible for, erythropoiesis stimulating agent (ESA) treatment, had not received prior treatment with either a HMA or lenalidomide and were non-del(5q). To be eligible for IMerge Phase 3, patients were required to be transfusion dependent, defined as requiring at least four units of packed red blood cells (RBCs), over an eight-week period during the 16 weeks prior to entry into the trial. The primary efficacy endpoint of IMerge Phase 3 is the rate of red blood cell transfusion independence (RBC-TI) lasting at least eight weeks, defined as the proportion of patients without any RBC transfusion for at least eight consecutive weeks since entry to the trial (8-week TI). Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks (24-week TI), the duration of TI and the rate of hematologic improvement erythroid (HI-E), which is defined under 2006 IWG criteria as a rise in hemoglobin of at least 1.5 g/dL above the pretreatment level for at least eight weeks or a reduction of at least four units of RBC transfusions over eight weeks compared with the prior RBC transfusion burden. A total of 178 patients were enrolled in IMerge Phase 3 across North America, Europe, Middle East and Asia.
About Imetelstat
Imetelstat is a novel, first-in-class investigational telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies. Imetelstat has been granted Fast Track designation by the U.S. Food and Drug Administration for both the treatment of adult patients with transfusion dependent anemia due to Low or Intermediate-1 risk MDS that is not associated with del(5q) who are refractory or resistant to an erythropoiesis stimulating agent, and for adult patients with Intermediate-2 or High-risk myelofibrosis (MF) whose disease has relapsed after or is refractory to janus associated kinase (JAK) inhibitor treatment. Imetelstat is currently not approved by any regulatory authority.