Geron Announces Data Presentations from IMerge Phase 3 Evaluating Imetelstat in Lower Risk MDS at Society of Hematologic Oncology Annual Meeting
07 Setembro 2023 - 9:00AM
Business Wire
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.
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.
About Geron
Geron is a late-stage clinical biopharmaceutical company
pursuing therapies with the potential to extend and enrich the
lives of patients living with hematologic malignancies. Our
first-in-class investigational telomerase inhibitor, imetelstat,
harnesses Nobel Prize-winning science in a treatment that may alter
the underlying drivers of disease. The New Drug Application (NDA)
for imetelstat in lower risk myelodysplastic syndromes (LR MDS),
based on the results from the Phase 3 IMerge clinical trial, is
currently under review by the United States Food and Drug
Administration (FDA) with a Prescription Drug User Fee Act (PDUFA)
target action date of June 16, 2024. Additionally, Geron currently
has an ongoing pivotal Phase 3 clinical trial evaluating imetelstat
in relapsed/refractory myelofibrosis (MF). To learn more, visit
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) the company’s
belief that the benefits seen in imetelstat-treated patients in the
IMerge Phase 3 trial, along with a manageable safety profile,
represent an unparalleled clinical benefit in lower risk MDS; (ii)
that FDA has assigned a PDUFA action date of June 16, 2024; (iii)
that imetelstat may alter the underlying drivers of disease and has
the potential to demonstrate disease-modifying activity in
patients; and (iv) other statements that are not historical facts,
constitute forward-looking statements. 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 permit the further development of imetelstat
on a timely basis, or at all, without any clinical holds; (b)
whether any future safety or efficacy results cause the
benefit-risk profile of imetelstat to become unacceptable; (c)
whether imetelstat actually demonstrates that it alters the
underlying drivers of disease and has disease-modifying activity in
patients; and (d) whether the FDA will extend the PDUFA action date
or approve imetelstat for the treatment of transfusion-dependent
anemia in patients with lower risk MDS. 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
quarterly report on Form 10-Q for the quarter ended June 30, 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 to reflect future information, events or
circumstances.
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version on businesswire.com: https://www.businesswire.com/news/home/20230907026431/en/
Aron Feingold Vice President, Investor Relations and Corporate
Communications Kristen Kelleher Senior Manager, Investor Relations
investor@geron.com media@geron.com
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