Data Reporting Median Overall Survival of 29.9
Months in High-Dose Arm
Geron Corporation (Nasdaq: GERN) today announced that results from
IMbark, a Phase 2 clinical trial of imetelstat treatment in
Intermediate-2 or High-risk myelofibrosis (MF) patients who are
relapsed or refractory to a Janus Kinase (JAK) inhibitor, were
presented at the 60th American Society of Hematology (ASH) Annual
Meeting in San Diego, California. The oral presentation was made on
December 3, 2018 by John Mascarenhas, M.D., Associate Professor of
Medicine in the Myeloproliferative Disorders Program of the Tisch
Cancer Institute, Division of Hematology/Oncology at the Icahn
School of Medicine at Mount Sinai, and an IMbark clinical
investigator.
“The IMbark results suggest a meaningful survival outcome in
this poor-prognosis, relapsed/refractory MF patient population
where there are currently no approved treatments,” said John A.
Scarlett, M.D., Geron’s President and Chief Executive Officer. “We
plan to explore potential late-stage development opportunities for
imetelstat in MF through discussions with experts in MF and
regulatory authorities and expect to provide a decision regarding
future development of imetelstat in this patient population by the
end of the third quarter of 2019.”
Clinical Data Presentation
Title: Imetelstat is Effective Treatment for Patients
with Intermediate-2 or High-Risk Myelofibrosis Who Have Relapsed on
or Are Refractory to Janus Kinase Inhibitor Therapy: Results of a
Phase 2 Randomized Study of Two Dose Levels (Abstract
#685)
IMbark is a Phase 2 clinical trial that evaluated two starting
dose levels of imetelstat (either 4.7 mg/kg or 9.4 mg/kg
administered by intravenous infusion every three weeks) in more
than 100 patients with Intermediate-2 or High-risk MF who have
relapsed after or are refractory to prior treatment with a JAK
inhibitor. The oral presentation highlighted efficacy and safety
data from the primary analysis, as well as overall survival data
with a clinical cutoff of October 22, 2018 and a median follow up
of approximately 27 months.
The co-primary efficacy endpoints for the trial are spleen
response rate, defined as the proportion of patients who achieve a
≥35% reduction in spleen volume assessed by imaging; and symptom
response rate, defined as the proportion of patients who achieve a
≥50% reduction in Total Symptom Score, at 24 weeks. Key secondary
endpoints are safety and overall survival.
For the 9.4 mg/kg dosing arm (n=59), the spleen response rate
was 10% (6/59) and the symptom response rate was 32% (19/59). In
addition, improvement in bone marrow fibrosis was observed in 25%
(15/59) of patients.
The new data presented at ASH indicate that median overall
survival (OS) for the 9.4 mg/kg dosing arm was 29.9 months, which
suggests a meaningful survival outcome with imetelstat treatment in
this poor-prognosis patient population, all of whom met rigorous
criteria for having failed or not responded to JAK inhibitor
treatment prior to enrollment in the trial. Other observational
studies of similar patient populations published in medical
literature have reported median OS ranged from approximately 12-14
months.
The safety profile reported for imetelstat-treated patients in
IMbark was consistent with prior clinical trials of imetelstat in
hematologic malignancies, and no new safety signals were
identified. 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.
Future Plan for Imetelstat in Relapsed/Refractory
MF
Based on the data from IMbark, Geron plans to discuss the
potential future development of imetelstat in MF with MF experts
and regulatory authorities. Such discussions will consider how the
IMbark results compare with other therapies currently available to
MF patients and enable a better understanding of the potential
significance of the IMbark results to patients and physicians. The
Company expects to outline a decision regarding potential future MF
development by the end of the third quarter of 2019.
Analyst and Investor Event
On December 10, 2018, Geron will host a webcasted event for
analysts and investors. At the event, Dr. John Mascarenhas will
reprise the oral presentation made at the ASH Annual Meeting, as
well as describe the unmet medical need in relapsed/refractory MF.
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 to
explore late-stage development of imetelstat for treating MF and
will provide a decision about this by the end of the third quarter
of 2019; that the IMbark results suggest a meaningful survival
outcome in the relapsed/refractory MF patient population; that
imetelstat may have disease-modifying activity; 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; (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; (iii) whether
imetelstat does demonstrate disease-modifying activity; and (iv)
whether experts in MF and regulatory authorities agree on and
support a development path, if any, for imetelstat in MF.
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.com media@geron.com
CG Capital877-889-1972
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