Geron Announces Publication in The Lancet of Results from the IMerge Phase 3 Clinical Trial Evaluating Imetelstat in Lower Risk MDS
December 04 2023 - 5:00AM
Business Wire
- Imetelstat is currently under regulatory review by the FDA and
EMA for the treatment of transfusion-dependent anemia in adult
patients with lower risk MDS
Geron Corporation (Nasdaq: GERN), a late-stage clinical
biopharmaceutical company, today announced publication in The
Lancet of results from the IMerge Phase 3 trial investigating
imetelstat versus placebo in patients with lower risk
myelodysplastic syndromes (MDS) relapsed/refractory or ineligible
for erythropoiesis stimulating agents (ESAs). The publication is
available online and will be available in print at a later
date.
“The Lancet’s publication of our IMerge Phase 3 manuscript is a
strong validation of the importance of this study within the field,
as well as a powerful way of reaching hematologists and other
providers globally with these potentially practice-changing
results,” said Faye Feller, M.D., Executive Vice President, Geron’s
Chief Medical Officer. “Based on the highly differentiated
qualities of imetelstat reported in this study, we believe that, if
approved by regulatory authorities, imetelstat could substantially
improve the treatment paradigm in certain patients with lower risk
MDS.”
Imetelstat is currently under regulatory review by the U.S. Food
and Drug Administration (FDA) and by the European Medicines Agency
(EMA) for approval in transfusion dependent anemia in patients with
lower risk MDS who have failed to respond or have lost response to
or are ineligible for ESAs.
“I am pleased with the publication in The Lancet of what I
believe are very powerful Phase 3 results with this unique
mechanism of action, telomerase inhibition, where we see long-term
and durable responses broadly across MDS subgroups. This includes
lower risk MDS patients without ring sideroblasts (RS-),
ESA-ineligible patients who have high serum EPO levels, and those
with high transfusion burden, whose needs are not being met by
today’s treatments,” said Uwe Platzbecker, M.D., Department of
Hematology, Cellular Therapy, Hemostaseology and Infectious
Diseases, Leipzig University Hospital, Leipzig, Germany, who is the
lead author on the manuscript and is an IMerge investigator. “With
regards to the safety results, neutropenia and thrombocytopenia
were predictable and manageable, with little to no significant
clinical consequences. These adverse events commonly occurred in
the first three cycles and frequently resolved within two
weeks.”
As previously reported, in the IMerge Phase 3 clinical trial,
the primary endpoint of red blood cell transfusion independence
(TI) for at least 8 consecutive weeks was significantly higher with
imetelstat vs. best supportive care (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. For patients achieving 8-week TI, median increases in
hemoglobin were 3.6 g/dL for imetelstat and 0.8 g/dL for placebo.
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. Treatment with imetelstat vs. placebo led to greater
reduction in variant allele frequency (VAF) in certain genes
commonly mutated in MDS, which was associated with longer TI
duration and increase in hemoglobin levels. Consistent with prior
imetelstat clinical experience, the most common adverse events were
thrombocytopenia and neutropenia that were manageable and of short
duration.
Click here to view The Lancet publication.
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. 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 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 for the treatment of transfusion dependent anemia in
patients with lower risk myelodysplastic syndromes (LR MDS) who
have failed to respond or have lost response to or are ineligible
for erythropoiesis-stimulating agents (ESAs), 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. In addition, an MAA is under review in the European Union
for the same proposed indication. Furthermore, 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: (i) that the IMerge Phase 3 results
could potentially be practice-changing; (ii) that imetelstat, if
approved by regulatory authorities, could substantially improve the
treatment paradigm in certain patients with lower risk MDS; (iii)
that imetelstat may alter the underlying drivers of disease in
myeloid hematologic malignancies 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 and
EMA will 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
September 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/20231204945481/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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