GlycoMimetics Announces U.S. Food and Drug Administration Clears Addition of Time-based Final Analysis to Pivotal Phase 3 Study of Uproleselan in Relapsed/Refractory Acute Myeloid Leukemia
15 Junio 2023 - 7:00AM
Business Wire
- Final analysis to be conducted after the earlier of 295
survival events or the FDA-aligned cutoff date; topline results
expected by the end of Q2 2024
- Prolonged duration of blinded pooled survival in
relapsed/refractory Acute Myeloid Leukemia expected to yield
clinically mature dataset in Q2 2024, supporting addition of
time-based analysis of overall survival primary endpoint
- Dataset is expected to reflect greater than three years of
median follow-up, including at least two years of post-transplant
data for a large majority of patients who received stem cell
transplantation
GlycoMimetics, Inc. (Nasdaq: GLYC) a late clinical-stage
biotechnology company discovering and developing glycobiology-based
therapies for cancers and inflammatory diseases, today announced
the U.S. Food and Drug Administration (FDA) cleared the addition of
a protocol amendment to the company’s pivotal Phase 3 study of
uproleselan for relapsed/refractory (R/R) Acute Myeloid Leukemia
(AML). The amendment will allow a time-based analysis of the
primary endpoint of overall survival to be conducted following a
defined cutoff date if the 295 survival events originally planned
for an event driven analysis have not been observed. With the
addition of a time-based analysis, topline results are expected to
be reported by the end Q2 2024.
“We are pleased the FDA cleared the addition of a time-based
pathway to final analysis as it provides the opportunity to
evaluate the effect of uproleselan on R/R AML based on a clinically
mature database with more than three years median follow-up,” said
Harout Semerjian, Chief Executive Officer of GlycoMimetics. “This
approach is consistent with regulatory precedent adopted for a
prior pivotal AML study for an approved drug and reflects our
commitment to science-driven analysis as we seek to deliver
uproleselan to R/R AML patients in need of new treatment options as
soon as possible.”
The Phase 3 trial completed enrollment of 388 patients across 70
sites in nine countries in November 2021. An event based final
analysis of overall survival was previously expected after year end
2022, but the number of events has slowed, resulting in the
projected timeline being extended.
Based on blinded pooled data observed to date, a time-based
final analysis in Q2 2024 is expected to yield a clinically mature
dataset to evaluate uproleselan in R/R AML. This dataset is
expected to reflect a median follow-up of greater than three years,
including at least two years of post-transplant data. The majority
of surviving patients in the study received hematopoietic stem cell
transplantation (HSCT). As a result, the company believes the
capture rate of survival events for this study beyond Q2 2024 would
provide limited additional value for the primary analysis.
Two years post-transplant is generally considered an important
milestone in AML because most patients who survive at least two
years post-transplant without experiencing disease relapse are
typically deemed to be long-term survivors. For patients over two
years post-transplant, disease relapse is less likely.1
As part of the protocol amendment, the FDA also cleared the
addition of landmark EFS and overall survival analyses as secondary
endpoints.
About Uproleselan
Discovered and developed by GlycoMimetics, uproleselan is an
investigational first-in-class, E-selectin antagonist. Uproleselan
(yoo’ pro le’se lan), currently in a comprehensive Phase 3
development program in acute myeloid leukemia (AML), has received
Breakthrough Therapy and Fast Track designations from the U.S. FDA
and Breakthrough Therapy designation from the Chinese National
Medical Products Administration for the treatment of adult AML
patients with relapsed or refractory disease. Uproleselan is
designed to block E-selectin binding and stimulation of myeloid
cells. E-selectin is expressed on the surface of blood vessels, and
its binding to myeloid cells confers a pro-survival effect.
Uproleselan intends to provide a novel approach to disrupting
established mechanisms of leukemic cell resistance.
About GlycoMimetics, Inc.
GlycoMimetics is a late clinical-stage biotechnology company
discovering and developing glycobiology-based therapies for
cancers, including AML, and for inflammatory diseases with high
unmet needs. The company’s science is based on an understanding of
the role that carbohydrates play in cell recognition. Its
specialized chemistry platform is deployed to discover small
molecule drugs, known as glycomimetics, which alter
carbohydrate-mediated recognition in diverse disease states,
including cancer and inflammation. As a leader in this science,
GlycoMimetics leverages this unique approach to advance its
pipeline of wholly-owned drug candidates, with the goal of
developing transformative therapies for diseases with high unmet
need. GlycoMimetics is headquartered in Rockville, MD in the
BioHealth Capital Region. Learn more at www.glycomimetics.com.
Forward-Looking Statements
This press release contains forward-looking statements. These
forward-looking statements may include, but are not limited to,
statements regarding the conduct of and data from clinical trials,
planned or potential clinical development, regulatory interactions
and submissions, and the potential benefits and impact of the
company’s drug candidate, uproleselan. Actual results may differ
materially from those described in these forward-looking
statements. For a further description of the risks associated with
these statements, as well as other risks facing GlycoMimetics,
please see the risk factors described in the Company’s Annual
Report on Form 10-K filed with the U.S. Securities and Exchange
Commission (SEC) on March 29, 2023, and other filings GlycoMimetics
makes with the SEC from time to time. Forward-looking statements
speak only as of the date of this release, and GlycoMimetics
undertakes no obligation to update or revise these statements,
except as may be required by law.
1 Bolon YT, Atshan R, Allbee-Johnson M, Estrada-Merly N, Lee SJ.
Current use and outcome of hematopoietic stem cell transplantation:
CIBMTR summary slides (slide 79), 2022.
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version on businesswire.com: https://www.businesswire.com/news/home/20230615994052/en/
Investors: Argot Partners Leo Vartorella/Collin Beloin
212-600-1902 Glycomimetics@argotpartners.com
Media: Geoff Cook 973-652-7927
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