An email has been sent to your address with instructions for changing your password.
There is no user registered with this email.
Sign Up
To create a free account, please fill out the form below.
Thank you for signing up!
A confirmation email has been sent to your email address. Please check your email and follow the instructions in the message to complete the registration process. If you do not receive the email, please check your spam folder or contact us for assistance.
Welcome to our platform!
Oops!
Something went wrong while trying to create your new account. Please try again and if the problem persist, Email Us to receive support.
Geron Announces Upcoming Oral Presentation at 2023 American Society of Clinical Oncology Annual Meeting of Imetelstat Data from IMerge Phase 3 Lower Risk MDS Trial
Geron Corporation (NASDAQ: GERN) announced that data from the pivotal IMerge Phase 3 clinical trial of its telomerase inhibitor, imetelstat, in lower-risk myelodysplastic syndromes (MDS) is scheduled for oral presentation at the 2023 ASCO Annual Meeting in Chicago. The study evaluates imetelstat in patients who are transfusion dependent and have relapsed or are refractory to erythropoiesis-stimulating agents. The primary efficacy endpoint is the rate of red blood cell transfusion independence lasting at least eight weeks, with secondary endpoints focusing on longer durations and hematologic improvement. The trial enrolled 178 patients across multiple regions. Geron plans to submit a New Drug Application in mid-2023 and a Marketing Authorization Application in the EU later this year.
Positive
Data from the pivotal IMerge Phase 3 trial accepted for presentation at ASCO 2023.
Imetelstat demonstrated potential for red blood cell transfusion independence in lower-risk MDS patients.
Plans for NDA submission in mid-2023 and MAA in the EU in H2 2023.
Negative
Regulatory acceptance of the NDA and MAA from authorities is uncertain.
Potential risks relating to actual demonstration of disease-modifying activity in clinical trials.
FOSTER CITY, Calif.--(BUSINESS WIRE)--
Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that data from the pivotal IMerge Phase 3 clinical trial evaluating the Company’s first-in-class telomerase inhibitor, imetelstat, in lower risk myelodysplastic syndromes (MDS), was accepted for oral presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. The data in the ASCO abstract will be embargoed per ASCO guidelines until May 25, 2023 at 5 p.m. Eastern Time. ASCO is taking place in Chicago, IL from June 2-6, 2023.
Details for the oral presentation are as follows:
Title:IMerge: Results from a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Imetelstat in Patients (pts) With Heavily Transfusion Dependent (TD) Non-Del(5q) Lower-Risk Myelodysplastic Syndromes (LR-MDS) Relapsed/Refractory (R/R) to Erythropoiesis Stimulating Agents (ESA).
Presenter:Amer Methqal Zeidan, Yale School of Medicine
Abstract number: 7004
Date:Friday, June 2, 2023
Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
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 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 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 telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies. Data from non-clinical studies and clinical trials of imetelstat provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. 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 MF whose disease has relapsed after or is refractory to janus associated kinase (JAK) inhibitor treatment. Geron plans to submit a New Drug Application (NDA) in the U.S. in mid-2023 and a Marketing Authorization Application (MAA) in the EU in the second half of 2023 in the lower risk MDS indication.
About Geron
Geron is a late-stage biopharmaceutical company pursuing therapies with the potential to extend and enrich the lives of patients living with hematologic malignancies. Its investigational first-in-class telomerase inhibitor, imetelstat, harnesses Nobel Prize winning science in a treatment that may alter the underlying course of these diseases. To learn more, visit http://www.geron.com/or follow us on LinkedIn.
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 for imetelstat in lower risk MDS, Geron plans to submit an NDA in the U.S. in mid-2023 and an MAA in the EU in the second half of 2023; (ii) that imetelstat has potential disease modifying activity; and (iii) other statements that are not historical. These forward-looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties include, without limitation, risks and uncertainties related to: (a) whether regulatory authorities accept for filing Geron’s NDA and MAA; (b) whether imetelstat actually demonstrates disease-modifying activity in patients in clinical trials; and (c) whether regulatory authorities continue to permit imetelstat to be administered to patients in clinical trials. Additional information on the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron’s filings and periodic reports filed with the Securities and Exchange Commission under the heading “Risk Factors” and elsewhere in such filings and reports, including Geron’s Annual Report on Form 10-K filed on March 16, 2023, and future filings and reports by Geron. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements.
What are the key findings from the IMerge Phase 3 trial by Geron Corporation?
The key findings will be presented at the ASCO Annual Meeting, focusing on the efficacy of imetelstat in achieving red blood cell transfusion independence.
When is the presentation date for the IMerge Phase 3 trial results?
The results will be presented on June 2, 2023.
What is the significance of the IMerge Phase 3 trial for Geron Corporation?
The trial's results are pivotal for Geron as they could lead to regulatory approvals for imetelstat in treating lower-risk MDS.
What regulatory submissions does Geron plan regarding imetelstat?
Geron plans to submit a New Drug Application in the U.S. in mid-2023 and a Marketing Authorization Application in the EU in the second half of 2023.
What type of patients were included in the IMerge Phase 3 trial?
Patients with heavily transfusion-dependent lower-risk MDS who were relapsed or refractory to erythropoiesis-stimulating agents were included.
