Geron Corporation (Nasdaq: GERN) today announced that an oral and a
poster presentation of clinical data and analyses related to
imetelstat, the Company’s first-in-class telomerase inhibitor, were
made at the 24th Annual Congress of the European Hematology
Association (EHA) held in Amsterdam, the Netherlands on June 15,
2019.
Updated Efficacy and Safety Data from the Phase 2
Portion of IMerge
“The EHA presentation for the Phase 2 portion of IMerge reported
higher efficacy responses from prior reported data for both 8-week
and 24-week RBC-TI rates, which highlight the meaningful and
durable transfusion independence achievable with imetelstat
treatment in heavily transfusion dependent lower risk MDS
patients,” said Aleksandra Rizo, M.D., Ph.D., Geron’s Chief Medical
Officer. “These data provide further support for the initiation of
the Phase 3 portion of the trial and Phase 3 start-up activities
for IMerge are continuing with the goal of opening for screening
and enrollment in August 2019.”
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) (Abstract #S837)
This oral presentation described updated efficacy and safety
data as of April 2019 from 38 imetelstat-treated patients in the
Phase 2 portion of the IMerge clinical trial with a median
follow-up of 15.7 months. All 38 patients represent a target
patient population of 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 the rate of red blood cell
transfusion independence (RBC-TI) lasting at least eight weeks, or
8-week RBC-TI rate, which is defined as the proportion of patients
achieving RBC-TI during any consecutive eight weeks since entry
into the trial. Key secondary endpoints include the rate of RBC-TI
lasting at least 24 weeks, or 24-week RBC-TI rate, and the rate of
hematologic improvement-erythroid (HI-E), defined as a reduction of
at least four units of RBC transfusions over eight weeks compared
with the prior RBC transfusion burden or a rise in hemoglobin of at
least 1.5 g/dL above pretreatment level for at least eight
weeks.
Efficacy Summary (n=38):
- 42% (16/38) of patients achieved ≥8-week RBC-TI
- 29% (11/38) of patients achieved ≥24-week RBC-TI
- Median duration of TI was 85.9 weeks (range:
8.0-140.9)
- 68% (26/38) of patients achieved HI-E, or improvement in red
blood cell count, as measured by either transfusion reduction or a
rise in hemoglobin:° All 26 patients had a reduction of at
least four RBC units over eight weeks compared with prior
transfusion burden° 12 of 26 patients had a hemoglobin
increase of at least 1.5 g/dL lasting at least eight weeks
- Mean relative reduction in transfusion burden from baseline was
68%
Additional data were presented showing that transfusion
independence was observed across different clinical subgroups, as
well as in patients with intermediate or poor cytogenetic risk.
Safety Summary:
- No new safety signals were identified. Reversible cytopenias
were the most frequent adverse events.
The slide presentation is available on Geron’s website at
www.geron.com/r-d/publications.
Statistical Analyses of Median Overall Survival in
IMbark Compared to Real World Data
“The EHA poster presentation reported the results of statistical
analyses in which the months of median overall survival for
imetelstat-treated relapsed/refractory MF patients in IMbark was
calculated to be more than double that for closely matched patients
treated with best available therapy using real-world data,” said
John A. Scarlett, M.D., Geron’s Chairman and Chief Executive
Officer. “The outcomes of these analyses were consistent across two
different approaches for propensity score analysis and additional
sensitivity analyses, underscoring the robustness of the
statistical methodologies applied.”
Abstract Title: Favorable Overall Survival of
Imetelstat-Treated Relapsed/Refractory Myelofibrosis Patients
Compared with Closely Matched Real World Data (Abstract
#PS1456)
This poster presentation provided a new analysis of overall
survival (OS) in relapsed/refractory MF patients treated with
imetelstat 9.4 mg/kg in the IMbark Phase 2 clinical trial, compared
to OS calculated from real world data (RWD) collected at the
Moffitt Cancer Center for patients who had discontinued treatment
from ruxolitinib, a JAK inhibitor, and who were subsequently
treated with best available therapy (BAT). To make a comparison
between the IMbark data and RWD, a cohort from the real-world
dataset was identified that closely matched the IMbark patients,
using guidelines for inclusion and exclusion criteria as defined in
the IMbark clinical protocol, such as platelet count and spleen
size.
To mimic the effect of randomization and improve comparability
between the IMerge and RWD populations, two different propensity
score approaches were used to balance these two populations with
respect to baseline covariates and prognostic factors that could
have impacted OS outcomes. The calculations from both propensity
score approaches resulted in a median OS of 30.7 months for the
imetelstat-treated patients from IMbark, which is more than double
the median OS of 12.0 months using RWD for patients treated with
BAT. The analysis also indicated a 65-67% lower risk of death for
the imetelstat-treated patients vs. BAT-treated patients. A
sensitivity analysis assessing the impact on OS of subsequent
hematopoietic stem cell transplantation showed no substantial
differences in median OS calculated for either the
imetelstat-treated or BAT-treated patients. The poster presentation
concluded that although there are limitations of such comparative
analyses between RWD and clinical trial data, favorable OS of
imetelstat treatment in this very poor-prognosis patient population
warrants further evaluation.
The poster is available at www.geron.com/r-d/publications.
Post-EHA Event with Key Opinion Leaders
On June 25, 2019, Geron will be hosting a webcasted event with
authors from each respective data presentation from the EHA Annual
Congress who will reprise the presentations from EHA. Information
regarding access to the webcast is available at
www.geron.com/investors/events.
Current Ongoing Clinical Trials of
Imetelstat
Patients currently enrolled in ongoing imetelstat clinical
trials continue to be supported through the respective trial
protocols, including treatment and follow-up.
Phase 2 Portion of IMerge
IMerge is a two-part Phase 2/3 clinical trial of imetelstat in
lower risk MDS. The first part of IMerge was designed as a Phase 2,
open label, single arm study to assess the efficacy and safety of
imetelstat. 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.
Key secondary endpoints include the rate of RBC-TI lasting at
least 24 weeks, or 24-week RBC-TI rate, and the rate of hematologic
improvement-erythroid (HI-E), defined as a reduction of at least
four units of RBC transfusions over eight weeks compared with the
prior RBC transfusion burden or a rise in hemoglobin of at least
1.5 g/dL above pretreatment level for at least eight weeks. To be
eligible for the Phase 2 or Phase 3 portion of IMerge, patients are
required to be transfusion dependent, defined as requiring at least
four units of packed RBCs over an eight-week period during the 16
weeks before entry into the trial. The Phase 2 portion of IMerge is
closed to new patient enrollment.
IMbark
IMbark was designed as a Phase 2 clinical trial to evaluate two
starting dose levels of imetelstat (either 4.7 mg/kg or 9.4 mg/kg
administered by intravenous infusion every three weeks) in patients
with Intermediate-2 or High-risk MF who have relapsed after or are
refractory to prior treatment with a janus kinase (JAK) inhibitor.
The co-primary efficacy endpoints for the trial are spleen response
rate and symptom response rate. Key secondary endpoints are safety
and overall survival (OS). IMbark is closed to new patient
enrollment.
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 consists of a Phase 2/3 trial, called IMerge,
in lower risk myelodysplastic syndromes (MDS) and a Phase 2 trial,
called IMbark, in Intermediate-2 or 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 late-stage clinical 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
in August 2019; (ii) that statistical analyses of IMbark data and
closely matched RWD suggest favorable overall survival with
imetelstat treatment when compared to closely matched RWD from
patients treated with BAT in relapsed/refractory MF; (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) whether imetelstat is able
to actually demonstrate a lower risk of death and favorable overall
survival compared to BAT in relapsed/refractory MF patients; (ii)
whether the comparative analyses between RWD and IMbark clinical
trial data described in the poster presentation have limitations
and cannot be relied upon as demonstrative; (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 in August 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; (vii) whether the Company will be able to
successfully retain or recruit key personnel to support its current
and future development plans or to otherwise successfully manage
its growth; (viii) the Company’s need for additional capital; and
(ix) 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 Capital887-889-1972
Geron (NASDAQ:GERN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Geron (NASDAQ:GERN)
Historical Stock Chart
From Sep 2023 to Sep 2024