Geron Corporation (Nasdaq: GERN) today announced that two abstracts
containing clinical data and analyses related to imetelstat, the
Company’s first-in-class telomerase inhibitor, have been accepted
for presentation at the 24th European Hematology Association (EHA)
Annual Congress to be held in Amsterdam, the Netherlands, from June
13-16, 2019. The abstracts are available on the EHA website at
www.ehaweb.org/congress.
“We appreciate the opportunity to present additional data and
analyses at EHA from the ongoing imetelstat clinical trials,” said
John A. Scarlett, M.D., Geron’s Chairman and Chief Executive
Officer. “In the Phase 2 portion of IMerge, the 8-week transfusion
independence rate increased compared to the data presented last
December, supporting the initiation of the Phase 3 portion of
IMerge that we plan to open for screening and enrollment by
mid-year 2019. For IMbark, the analyses reported in the abstract
suggest that treatment with imetelstat is associated with a lower
risk of death compared to best available therapy from closely
matched real-world data from patients with Intermediate-2 or
High-risk myelofibrosis after JAK inhibitor failure.”
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 American
Society of Hematology Annual Meeting in December 2018. The most
frequently reported adverse events were manageable and reversible
grade ≥3 cytopenias.
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
TreatmentSession Date: Saturday, June 15Session Time: 11:30 – 11:45
a.m. CETAbstract 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 Moffitt Cancer Center. For comparability
between the IMbark data and the RWD, several baseline clinical
patient characteristics, such as, platelet count, spleen size, time
from diagnosis to JAKi therapy discontinuation, MF type and others,
were selected to assess the average treatment effect of imetelstat
or BAT. Using propensity score approaches, median overall survival
in the imetelstat-treated patients from IMbark was calculated to be
30.69 months compared to a median overall survival that was
calculated to be 12.04 months in patients treated with BAT at the
Moffitt Cancer Center (hazard ratio 0.35, p<.0019). These
analyses suggest that treatment with imetelstat is associated with
a lower risk of death compared to BAT from closely matched RWD from
patients with Intermediate-2 or High-risk MF after JAKi
failure.
Poster Presentation Details:Session Title: Myeloproliferative
neoplasms—Clinical Session Date: Saturday, June 15Session Time:
5:30 – 7:00 p.m. CETAbstract 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
On June 25, 2019, Geron plans to host a webcasted event after
the EHA Annual Congress. At the event, authors from each of the
imetelstat abstracts will reprise the respective presentations from
the EHA Annual Congress. A press release with event details,
including how to access a webcast link, will be available on
Geron’s website at the beginning of June.
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: (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 June
2019; (iii) that statistical analyses of IMbark data and closely
matched RWD suggest treatment with imetelstat is associated with a
lower risk of death compared to BAT; (iv) that imetelstat may have
disease-modifying activity; and (v) 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) availability of
more mature data from IMerge for an update at EHA; (ii) whether
imetelstat is able to demonstrate a lower risk of death
compared to BAT; (iii) whether the Company overcomes all the
clinical, safety and efficacy, technical, scientific, manufacturing
and regulatory challenges to enable the opening of the Phase 3
portion of IMerge for screening and enrollment by mid-year 2019;
(iv) whether regulatory authorities permit the further development
of imetelstat on a timely basis, or at all, without any clinical
holds; (v) whether imetelstat is safe and efficacious; (vi) whether
any future efficacy or safety results may cause the benefit-risk
profile of imetelstat to become unacceptable; and (vii) whether
imetelstat demonstrates disease-modifying activity. 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 March
31, 2019. 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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