Analyses
Suggest Survival Benefit Associated with Imetelstat Treatment in
Comparison to Best Available Therapy
Overall
Survival is Primary Endpoint for Ongoing Phase 3 Clinical Trial in
Refractory MF
Geron Corporation (Nasdaq: GERN), a late-stage biopharmaceutical
company focused on the development and commercialization of
treatments for hematologic malignancies, today announced the
publication in the Annals of Hematology of a paper entitled
“Favorable Overall Survival with Imetelstat in Relapsed/Refractory
Myelofibrosis Patients Compared with Real World Data,” which
details statistical analyses comparing data from the Company’s
IMbark Phase 2 clinical trial to closely matched Real World Data
(RWD).
“Across the multiple analyses presented in the publication, the
median overall survival for imetelstat-treated patients in our
IMbark Phase 2 clinical trial was consistently more than double
than the median overall survival for patients treated with best
available therapy (BAT) from RWD. For the imetelstat-treated
patients, the median overall survival (OS) was approximately 30
months in comparison to approximately 12 months for BAT-treated
patients from RWD,” said Aleksandra Rizo, M.D., Ph.D., Geron’s
Chief Medical Officer. “We are pleased with the publication of this
important work as these analyses provide us further confidence in
the use of OS as the primary endpoint for our ongoing confirmatory
IMpactMF Phase 3 trial.”
The paper describes several statistical adjustment methods and
multiple sensitivity analyses to improve comparability of the data
set from the Company’s IMbark Phase 2 trial and RWD to mimic the
effect of a randomized trial. The authors note consistency in the
hazard ratios and statistical significance observed across the
multiple analyses, which suggests a survival benefit associated
with imetelstat treatment of MF patients after ruxolitinib failure.
While acknowledging the limitations of RWD analyses, the authors
conclude that the results of these analyses warrant further
prospective evaluation of imetelstat in a Phase 3 setting with OS
as a primary endpoint.
“The RWD used in this paper was collected from patients treated
with BAT at the Moffitt Cancer Center after they had discontinued
treatment from ruxolitinib, a JAK inhibitor,” said Rami Komrokji,
M.D., Vice Chair, Department of Malignant Hematology at Moffitt
Cancer Center. “There is an urgent and unmet need for treatment
options with a novel mechanism of action for MF patients who are
relapsed/refractory to JAK inhibitors. The reported favorable OS
with imetelstat treatment in this as well as in prior publications
in this very poor prognosis MF patient population differentiates
imetelstat from other therapeutic agents in development for MF
today. We are excited to participate in Geron’s ongoing IMpactMF
clinical trial to confirm these data.”
The publication is available online at
https://link.springer.com/article/10.1007/s00277-021-04683-w.
Ongoing IMpactMF Phase 3 Clinical Trial
IMpactMF is an open label, randomized, controlled Phase 3
clinical trial with registrational intent. The trial is designed to
enroll approximately 320 patients with Intermediate-2 or High-risk
myelofibrosis who are refractory to prior treatment with a JAK
inhibitor, also referred to as refractory MF. Patients will be
randomized to receive either imetelstat or best available therapy.
The primary endpoint is overall survival (OS). Key secondary
endpoints include symptom response, spleen response, progression
free survival, complete response, partial response, clinical
improvement, duration of response, safety, pharmacokinetics, and
patient reported outcomes.
IMpactMF is currently enrolling patients. For further
information about IMpactMF, including enrollment criteria,
locations and current status, visit
ClinicalTrials.gov/NCT04576156.
About Myelofibrosis (MF)
Myelofibrosis, a type of myeloproliferative neoplasm, is a
chronic blood cancer in which abnormal or malignant precursor cells
in the bone marrow proliferate rapidly, causing scar tissue, or
fibrosis, to form. People with MF may have abnormally low or high
numbers of circulating red blood cells, white blood cells or
platelets, and abnormally high numbers of immature cells in the
blood or bone marrow. MF patients can also suffer from debilitating
constitutional symptoms, such as drenching night sweats, fatigue,
severe itching, or pruritus, abdominal pain, fever and bone
pain.
Approximately 70% of MF patients are classified as having
Intermediate-2 or High-risk disease, as defined by the Dynamic
International Prognostic Scoring System Plus. There are more than
35,000 patients worldwide and more than 13,000 patients in the U.S.
living with Intermediate-2 or High-risk MF. The only drug therapies
approved for treating these MF patients are JAK inhibitors.
Currently, MF patients who fail or no longer respond to JAK
inhibitor treatment have no or limited options, resulting in
shortened median overall survival.
About Imetelstat
Imetelstat is a novel, first-in-class telomerase inhibitor
exclusively owned by Geron and being developed in myeloid
hematologic malignancies. Data from Phase 2 clinical trials 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 United States Food and
Drug Administration for both the treatment of patients with
non-del(5q) lower risk MDS who are refractory or resistant to an
erythropoiesis-stimulating agent (ESA) and for patients with
Intermediate-2 or High-risk MF whose disease has relapsed after or
is refractory to janus associated kinase (JAK) inhibitor
treatment.
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 myeloid
hematologic malignancies. The Company currently is conducting two
Phase 3 clinical trials: IMerge in lower risk myelodysplastic
syndromes and IMpactMF in refractory myelofibrosis. 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
consistency in the hazard ratios and statistical significance
observed across multiple analyses suggests a survival benefit
associated with imetelstat treatment of MF patients after
ruxolitinib failure; (ii) that imetelstat has potential
disease-modifying activity; and (iii) 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 in
IMpactMF imetelstat is able to actually demonstrate a favorable
overall survival compared to BAT in refractory MF patients; (ii)
that the comparative analyses between RWD and IMbark clinical trial
data have limitations and cannot be relied upon as demonstrative;
(iii) whether regulatory authorities permit the further development
of imetelstat on a timely basis, or at all, without any clinical
holds; (iv) whether imetelstat is safe and efficacious; and (v)
whether imetelstat demonstrates disease-modifying activity in
IMpactMF. 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 June 30, 2021. 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/20211011005605/en/
Olivia Bloom Chief Financial Officer investor@geron.com
media@geron.com
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