GlycoMimetics to Present Analyses from Phase 1/2 AML Trial of Uproleselan at 60th ASH Meeting
- New and updated clinical outcomes data and subgroup analyses continue to demonstrate potential benefit of treatment with uproleselan when added to chemotherapy
- 69 percent (11 out of 16) of evaluable patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and 56 percent (5 out of 9) of evaluable patients with newly diagnosed AML achieved MRD-negative remission in clinical trial
- Correlation of E-selectin ligand expression on leukemic blasts and leukemic stem cells (LSCs), as well as clinical data showing that E-selectin ligand expression on leukemic blasts is associated with poor outcomes in patients with AML, also support clinical trial program
Of particular note, the final analysis from the recently completed Phase
1/2 AML trial of uproleselan, an E-selectin antagonist and the company’s
lead wholly owned clinical candidate, has been selected for an oral
presentation on
In addition, a poster presentation of complementary work by
investigators at the
“Our oral presentation at ASH is noteworthy in that we show for the
first time that the majority of evaluable patients (11 out of 16) in the
R/R cohort and more than half of evaluable patients (5 out of 9) in the
newly diagnosed cohort achieved measurable residual disease negativity
as assessed by either flow and/or RT-PCR, when uproleselan is added to a
standard chemotherapy regimen,” noted
According to the Phase 1/2 trial’s lead investigator
Featured GlycoMimetics’ ASH data include the following:
- R/R AML Cohort: At the recommended Phase 2 dose (RP2D), CR (complete response)/CRi (complete remission with incomplete blood count recovery) rate was 41%, median overall survival was 8.8 months (95% CI 5.7-11.4) and 69% of evaluable patients (11/16) achieved measurable residual disease negativity as assessed by either flow and/or RT-PCR. Overall survival (OS) will be the primary outcome measure in the company’s Phase 3 trial in R/R AML patients, and the data reported today compares to 5.2-5.4 months OS in comparable historical controls. 1,2 (Abstract #331)
-
Newly Diagnosed (ND) AML Cohort: At the RP2D, CR/CRi rate was 72%,
median overall survival was 12.6 months (95% CI 9.9-not reached),
Event Free Survival (EFS) was 9.2 months (3.0-12.6) and 56% of
evaluable patients (5 out of 9) achieved measurable residual disease
negativity as assessed by either flow and/or RT-PCR. EFS will be the
primary outcome measure for the interim analysis in the
National Cancer Institute clinical trial in newly diagnosed patients, and the data presented today compare to 2-6.5 months for EFS in historical controls which represent lower risk patient populations than those treated in our study. 3,4 (Abstract #331) -
Based on data from 89 serially acquired AML patient samples at the
Fred Hutchinson Cancer Research Center , mean fluorescence intensity of E-selectin-Fc binding is four-fold higher for R/R patients than for newly diagnosed patients (p=0.0026), suggesting that sequestration in the vascular niche of the bone marrow is associated with chemotherapy resistance. (Abstract #1513)
Other GlycoMimetics ASH presentations will showcase the potential use of
uproleselan to mobilize hematopoietic stem cells with increased
reconstitution potential, as well as highlight two new novel compounds
discovered by
Presentation details:
Publication Number: 331
TITLE: Uproleselan (GMI-1271), an
E-Selectin Antagonist, Improves the Efficacy and Safety of Chemotherapy
in Relapsed/Refractory (R/R) and Newly Diagnosed Older Patients with
Acute Myeloid Leukemia: Final, Correlative and Subgroup Analyses
Session
Name: 616. Acute Myeloid Leukemia: Novel Therapy, excluding
Transplantation: Combination Therapy
Session Date:
Session Time:
Presentation
Time:
Room: Manchester Grand Hyatt San Diego, Grand Hall B
Publication Number: 1513
TITLE: E-Selectin Ligand
Expression by Leukemic Blasts Is Associated with Prognosis in Patients
with AML
Session Name: 617. Acute Myeloid Leukemia: Biology,
Cytogenetics, and Molecular Markers in Diagnosis and Prognosis: Poster I
Session
Date:
Presentation Time:
Location:
Publication Number: 2211
TITLE: A Novel Glycomimetic
Compound (GMI-1757) with Dual Functional Antagonism to E-Selectin and
Galectin-3 Demonstrates Inhibition of Thrombus Formation in an Inferior
Session Name: 802. Chemical Biology and
Experimental Therapeutics: Poster I
Session Date:
Presentation Time:
Location:
Publication Number: 3846
TITLE: The Vascular Bone Marrow
Niche Influences Outcome in Chronic Myeloid Leukemia
Session
Name: 506. Hematopoiesis and Stem Cells: Microenvironment, Cell
Adhesion, and Stromal Stem Cells: Poster III
Session Date:
Presentation Time:
Location:
Publication Number: 4552
TITLE: Vascular E-Selectin Acts
as a Gatekeeper Inducing Commitment and Loss of Self-Renewal in HSC
Transmigrating through the Marrow Vasculature
Session Name:
711. Cell Collection and Processing: Poster III
Session Date:
Presentation Time:
Location:
Publication Number: 4678
TITLE: A Novel and Potent
Inhibitor of E-Selectin, GMI-1687, Attenuates Thrombus Formation and
Augments Chemotherapeutic Intervention of AML in
Session Name: 802.
Chemical Biology and Experimental Therapeutics: Poster III
Session
Date:
Presentation Time:
Location:
Meeting abstracts are available on ASH’s website.
1 Feldman et al, J Clin Oncol. 2005 Jun
20;23(18):4110-6.
2 Greenberg et al, J
Clin Oncol. 2004 Mar 15;22(6):1078-86.
3
Lowenberg et al, N Engl J Med. 2009 Sep 24;361(13).
4
Lancet et al, Blood. 2014 May 22;123(21):3239-46.
About Uproleselan (GMI-1271)
Uproleselan (yoo’ pro le’sel an) is designed to block E-selectin (an
adhesion molecule on cells in the bone marrow) from binding with blood
cancer cells as a targeted approach to disrupting well-established
mechanisms of leukemic cell resistance within the bone marrow
microenvironment. In a Phase 1/2 clinical trial, uproleselan was
evaluated in both newly diagnosed elderly and relapsed/refractory
patients with AML. In both populations, patients treated with
uproleselan together with standard chemotherapy achieved better than
expected remission rates and overall survival compared to historical
controls, which have been derived from results from third party clinical
trials evaluating standard chemotherapy, as well as lower than expected
induction-related mortality rates. Treatment in these patient
populations was generally well tolerated, with fewer than expected
adverse effects.
About
GlycoMimetics is a clinical-stage biotechnology company focused on the
discovery and development of novel glycomimetic drugs to address unmet
medical needs resulting from diseases in which carbohydrate biology
plays a key role.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements regarding the
clinical development of the company’s drug candidates, including the
expected enrollment in and conduct of clinical trials, the presentation
of clinical data, and expiration of issued patents. Actual results may
differ materially from those in these forward-looking statements. For a
further description of the risks associated with these statements, as
well as other risks facing
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Source:
GlycoMimetics, Inc.
Investor Contact:
Shari Annes, 650-888-0902
sannes@annesassociates.com
or
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Contact:
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