Geron Announces Two Presentations on Imetelstat at Upcoming European Hematology Association Annual Congress
“We appreciate the opportunity to present additional data and analyses at EHA from the ongoing imetelstat clinical trials,” said
Updated Efficacy and Safety Data from the Phase 2 Portion of IMerge
Abstract Title: Treatment with Imetelstat Provides Durable Transfusion Independence (TI) in Heavily Transfused Non-del(5q) Lower Risk MDS (LR-MDS) Relapsed/Refractory (R/R) to Erythropoiesis Stimulating Agents (ESAs)
The abstract, accepted for an oral presentation, reports updated efficacy and safety data from 38 patients treated with imetelstat in Part 1 of IMerge, a Phase 2 clinical trial in transfusion dependent, non-del(5q) lower risk myelodysplastic syndromes (MDS) patients who are relapsed or refractory to ESAs and naïve to hypomethylating agent (HMA) and lenalidomide treatment. The primary efficacy endpoint is 8-week RBC-TI rate, which is defined as the proportion of patients achieving red blood cell transfusion independence during any consecutive eight weeks since entry into the trial.
In the preliminary data set used to prepare the abstract, the 8-week RBC-TI rate was 45% (17/38). Based on the most recent clinical cut-off date, used to prepare the IMerge clinical data for the transition of the imetelstat program, the 8-week RBC-TI rate is 42% (16/38), which is an increase of two new responders compared to the 8-week RBC-TI rate of 37% (14/38) reported at the
The abstract states these data support initiation of Part 2 of IMerge, the Phase 3 placebo-controlled trial, which is planned to be open for screening and enrollment by mid-year 2019.
Oral Presentation Details:
Session Title: Improvements in MDS Treatment
Session Time: 11:30 –
Abstract Code: S837
The oral presentation is expected to provide more mature efficacy and safety data for the Phase 2 portion of IMerge.
Analysis of Overall Survival Data from IMbark
Abstract Title: Favorable Overall Survival of Imetelstat-Treated Relapsed/Refractory Myelofibrosis Patients Compared with Closely Matched Real World Data
This abstract, accepted for a poster presentation, provides a new analysis of the overall survival (OS) benefit in patients treated with imetelstat 9.4 mg/kg during the IMbark Phase 2 clinical trial, compared to real-world data (RWD) from patients who had discontinued from a JAK inhibitor (JAKi). For this analysis, historical RWD were collected from a single-center study of patients who had discontinued ruxolitinib. A closely matched cohort of these patients was identified using guidelines for inclusion and exclusion criteria as defined in the IMbark clinical protocol, and consisted of patients who had discontinued JAKi due to lack or loss of response and were subsequently treated with best available therapy (BAT) at the
Poster Presentation Details:
Session Title: Myeloproliferative neoplasms—Clinical
Session Time: 5:30 –
Abstract Code: PS1456
In accordance with EHA policies, abstracts submitted to the EHA Annual Congress are embargoed from the time of submission. To be eligible for presentation at the EHA Annual Congress, any additional data or information to be presented at the Annual Congress may not be made public before the presentation. The slide presentation and poster will be available at www.geron.com/r-d/publications following the EHA Annual Congress presentations.
Post-EHA Event with Key Opinion Leaders
Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Early clinical data suggest imetelstat may have disease-modifying activity through the suppression of malignant progenitor cell clone proliferation, which allows potential recovery of normal hematopoiesis. Ongoing clinical studies of imetelstat include a Phase 2/3 trial, called IMerge, in lower risk myelodysplastic syndromes (MDS) and a Phase 2 trial, called IMbark, in Intermediate-2 to High-risk myelofibrosis. Imetelstat received Fast Track designation from the
Geron is a clinical stage biopharmaceutical company focused on the development and potential commercialization of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.
Use of Forward-Looking Statements
Except for the historical information contained herein, this press release contains forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such statements, include, without limitation, those regarding: (i) that the Phase 3 portion of IMerge will be open for patient screening and enrollment by mid-year 2019; (ii) that more mature data for the Phase 2 portion of IMerge will be presented at the EHA meeting in
Source: Geron Corporation