Geron Corporation (Nasdaq: GERN) today announced that updated
results from Part 1 of IMerge, the Phase 2 portion of a Phase 2/3
clinical trial of imetelstat in lower risk myelodysplastic
syndromes (MDS), were presented at the 60th American Society of
Hematology (ASH) Annual Meeting in San Diego, California on
December 2, 2018. The oral presentation was made by David Steensma,
M.D., Institute Physician at the Dana-Farber Cancer Institute and
Associate Professor at Harvard Medical School, and an IMerge
clinical investigator. Geron believes these results support
initiating the Phase 3 portion of IMerge to address an unmet
medical need for patients for whom erythropoiesis stimulating
agents (ESAs) are not effective and for whom currently available
therapies show only modest efficacy.
“The results from the Phase 2 portion of IMerge presented at ASH
highlight imetelstat’s broad clinical activity, especially in
difficult-to-treat patients, as indicated by the high baseline
transfusion burden of the patients enrolled in IMerge. As such, we
believe imetelstat could offer a much-needed alternative treatment
in lower risk MDS,” said John A. Scarlett, M.D., Geron’s President
and Chief Executive Officer. “We remain committed to developing
imetelstat and continue to plan the initiation of the Phase 3
portion of IMerge by mid-year 2019.”
IMerge Phase 2/3 Clinical Trial Design
IMerge is a two-part clinical trial evaluating imetelstat in
transfusion dependent patients with Low or Intermediate-1 risk MDS
who have relapsed after or are refractory to prior treatment with
an ESA. The first part of the trial was originally designed as a
Phase 2, open-label, single-arm trial to assess the efficacy and
safety of imetelstat. The second part of the trial is planned as a
Phase 3 double-blind, randomized, placebo-controlled trial in
approximately 170 patients. To be considered for enrollment into
IMerge, patients had to be transfusion dependent, requiring ≥4
units of red blood cells (RBC) over 8 weeks prior to entry into the
trial. The primary efficacy endpoint of the trial is the rate of
RBC transfusion-independence (RBC TI) lasting at least 8 weeks,
defined as the proportion of patients without any RBC transfusion
during any consecutive 8 weeks since entry into the trial. Key
secondary endpoints are the rate of ≥24-week RBC TI and the rate of
hematologic improvement-erythroid (HI-E), defined as a rise in
hemoglobin of at least 1.5 g/dL above the pretreatment level for at
least 8 weeks or a reduction of at least 4 units of RBC
transfusions over 8 weeks compared with the prior RBC transfusion
burden.
Among the first 32 patients enrolled in the Phase 2 portion of
IMerge, an initial cohort of 13 patients, who were non-del(5q) and
naïve to HMA and lenalidomide treatment, showed an increased RBC TI
rate and durability compared to the overall trial population. Thus,
earlier this year, an additional expansion cohort of 25 patients
were enrolled who were non-del(5q) and naïve to HMA and
lenalidomide treatment in order to increase the experience and
confirm the benefit-risk profile of this target patient
population.
Clinical Data Presentation
Title: Imetelstat Treatment Leads to Durable Transfusion
Independence (TI) in RBC Transfusion-Dependent (TD), Non-Del(5q)
Lower Risk MDS Relapsed/Refractory to Erythropoiesis-Stimulating
Agent (ESA) Who Are Lenalidomide and HMA Naïve (Abstract
#463)
The oral presentation described combined data with a data
cut-off date of October 26, 2018 for the target patient population
(n=38) in the Phase 2 portion of IMerge, which includes 13 patients
from the initial cohort and 25 patients from the expansion cohort.
The initial cohort had a median follow up time of 29 months, and
the expansion cohort had a median follow up of almost nine months.
As of the data cut-off date, median duration of RBC TI had not been
reached for the target patient population. Geron expects further
data from the Phase 2 portion of IMerge for the target patient
population reflecting longer follow up to be available in 2019 and
anticipates submitting such data for presentation at a future
medical conference.
Efficacy Highlights for Target Patient Population (n=38):
- 37% (14/38) of patients achieved ≥8-week RBC TI
- 26% (10/38) of patients achieved ≥24-week RBC TI
- Rate of transfusion reduction (HI-E) was 71% (27/38)
- Mean relative reduction of RBC transfusion burden from baseline
was 68%
- Broad clinical activity observed• Similar 8-week RBC TI was
observed in patients with baseline serum erythropoietin (sEPO)
levels less than or greater than 500mU/mL• 8-week RBC TI
consistent across ring-sideroblast (RS) patient subtypes, RS+ and
RS-
- Reductions in mutation burden and presence of RS noted among
responding patients, suggesting potential disease modifying
activity
Safety Summary for Target Patient Population (n=38):
- Cytopenias, particularly neutropenia and thrombocytopenia, were
the most frequently reported adverse events which were predictable,
manageable and reversible
The slides from the oral presentation at ASH are available on
Geron’s website at www.geron.com/r-d/publications.
Phase 3 Development Plan for Lower Risk MDS
Based on the combined data from the initial and expansion
cohorts for the target patient population in the Phase 2 portion of
IMerge, Geron plans to initiate the Phase 3 portion of IMerge after
the sponsorship of the ongoing imetelstat clinical trials has been
transferred back to Geron. Geron anticipates patient screening and
enrollment for the Phase 3 portion of IMerge to begin by mid-year
of 2019.
Analyst and Investor Event
On December 10, 2018, Geron will host a webcasted event for
analysts and investors. At the event, Dr. Azra Raza, a clinical
investigator for IMerge, will reprise the oral presentation made at
the ASH Annual Meeting, as well as describe the unmet medical need
in lower risk MDS. A live audio webcast of the event will be
available on Geron’s website, www.geron.com/investors/events. If
you are unable to listen to the live presentation, an archived
webcast of the event will be available on the Company’s website for
30 days.
About Imetelstat
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 United States
Food and Drug Administration for the treatment of patients with
transfusion-dependent anemia due to lower risk MDS who are
non-del(5q) and refractory or resistant to an erythroid stimulating
agent.
About Geron
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 that Geron plans and
anticipates that the screening, enrollment and initiation of the
Phase 3 portion of IMerge will begin by mid-year 2019; that
imetelstat may have disease modifying activity and could offer an
alternative treatment in lower risk MDS; and other statements that
are not historical facts, constitute forward-looking statements.
These 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: (i) whether
regulatory authorities permit the further development of imetelstat
on a timely basis, or at all, to enable patient screening and
enrollment of the Phase 3 portion of IMerge to begin by mid-year
2019; (ii) whether imetelstat is safe and efficacious, and whether
any past or future efficacy or safety results may cause the
benefit-risk profile of imetelstat to become unacceptable; and
(iii) whether the transition of the imetelstat program from Janssen
Biotech, Inc. to the Company proceeds on a timely basis to enable
the Phase 3 portion of IMerge to begin by mid-year
2019. 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 periodic
reports filed with the Securities and Exchange
Commission under the heading “Risk Factors,” including Geron’s
quarterly report on Form 10-Q for the quarter ended September
30, 2018. 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.
CONTACT:
Suzanne MessereInvestor and Media
Relationsinvestor@geron.commedia@geron.com
CG Capital877-889-1972
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