NewLink Genetics Presents Encouraging Updated Phase 1 Data with Indoximod Plus Chemotherapy in Frontline AML in an Oral Sessi...
December 02 2018 - 12:30PM
Business Wire
- Updated Phase 1 data for indoximod plus
standard-of-care chemotherapy in newly diagnosed AML show
post-induction minimal residual disease (MRD) negativity rate of
86% and post-consolidation MRD negativity of 100%
- Safety data from this study indicate
the combination treatment regimen was well tolerated with no
regimen limiting toxicities (RLTs) observed
NewLink Genetics Corporation (NASDAQ:NLNK) announced that
updated Phase 1 data evaluating indoximod plus
standard-of-care chemotherapy for the treatment of adult patients
with newly diagnosed acute myeloid leukemia (AML) were presented
today by Ashkan Emadi, MD, PhD, Professor of Medicine and Associate
Director for Clinical Research, University of Maryland Greenebaum
Comprehensive Cancer Center, in an oral session today at the 60th
American Society of Hematology (ASH) Annual Meeting in San Diego,
CA, from 9:30AM – 11:00AM PT, in Grand Hall B, Manchester Grand
Hyatt.
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Indoximod plus Chemotherapy in Acute
Myeloid Leukemia (AML) (Graphic: Business Wire)
This Phase 1 trial evaluated the initial safety and preliminary
evidence of clinical activity of adding indoximod to standard 7+3
induction and high-dose cytarabine (HiDAC) consolidation
chemotherapy for adult patients with newly diagnosed AML. The
presentation highlighted an initial safety profile indicating that
the treatment regimen was well tolerated with adverse events
commensurate with chemotherapy alone. Evidence of clinical activity
was observed for indoximod plus chemotherapy in newly diagnosed AML
as supported by these Phase 1 data showing post-induction minimal
residual disease (MRD) negativity rate of 86% and post-HiDAC1 MRD
negativity of 100%.
“These data demonstrate the promising potential for indoximod in
combination therapy for patients with newly diagnosed AML and the
use of MRD status as a study endpoint,” said Dr. Ashkan Emadi.
“We remain encouraged and look forward to additional data as this
study proceeds.”
Fifty-seven patients were screened, and 38 patients initiated
induction therapy on protocol. Five patients never received
indoximod resulting in an intent-to-treat (ITT) population of 33
patients. Twenty-two patients received the pre-specified 80% of
indoximod dosing required to be included in the per protocol (PP)
analysis, 8 received less than 80% of the scheduled indoximod
dosage, and 3 patients remained on induction treatment as of the
date of data cut off. Of these 22 PP patients, 16/22 (73%) achieved
complete morphological response (CR) and 6 were primary refractory.
Of the patients who achieved CR, 14 had results available from MRD
testing post-induction. MRD negativity was defined by a flow
cytometry assay at a level of < 0.02% (Hematologics, Inc.,
Seattle, WA). Of those tested, 12/14 (86%) were MRD-negative. Of
the 14 patients, 1 patient proceeded to transplant, and 13 began
HiDAC consolidation therapy. Post-HiDAC consolidation, all 13
patients were tested for MRD status with all 13/13 (100%) reported
to be MRD-negative. When benchmarked against available published
studies, these initial data appear encouraging. For a more precise
comparison, a contemporaneous multi-institutional dataset is being
aggregated to benchmark these data against data generated from
patients undergoing the same chemotherapy regimen without the
addition of indoximod using the same MRD assay assessed at the same
reference laboratory.
Safety data from this Phase 1 trial indicate that the
combination therapy regimen was well tolerated. No RLTs were
observed when combining indoximod with standard-of-care
chemotherapy. Grade 3 or greater adverse hematologic events
included febrile neutropenia, anemia, and thrombocytopenia while
non-hematologic events included hypoxia, anemia, and pneumonia. The
overall adverse event profile observed in this small sample size is
consistent with that of 7+3 induction chemotherapy plus HiDAC
consolidation alone.
About AML1,2
Adult acute myeloid leukemia (AML) is a cancer of the blood and
bone marrow in which the bone marrow makes abnormal types of white
blood cells, red blood cells, or platelets. AML is the most common
type of acute leukemia in adults and tends to progress rapidly
without treatment. In the US, approximately 19,000 patients per
year are diagnosed with AML with only around 25% expected to
survive longer than three years. Of those newly diagnosed patients,
approximately half are categorized as young and fit for an
aggressive chemotherapy treatment regimen.
1 National Cancer Institute2 American Society of Clinical
Oncology
About Indoximod
Indoximod is an investigational, orally available small molecule
targeting the IDO pathway. The IDO pathway is a key immuno-oncology
target, suppressing immune response and allowing for immune escape
by degrading tryptophan with the resultant production of
kynurenine. Indoximod reverses the immunosuppressive effects of low
tryptophan and high kynurenine through mechanisms that include
modulation of the AhR-driven transcription of genes that control
immune function. This results in increased proliferation of
effector T cells, increased differentiation into helper T cells
rather than regulatory T cells, and downregulation of IDO
expression in dendritic cells. Indoximod is being evaluated in
combination with treatment regimens including chemotherapy,
radiation, checkpoint blockade and cancer vaccines across multiple
indications including recurrent pediatric brain tumors, DIPG, and
AML.
About NewLink Genetics Corporation
NewLink Genetics is a clinical stage biopharmaceutical
company focusing on developing novel immuno-oncology product
candidates to improve the lives of patients with cancer. NewLink
Genetics' IDO pathway inhibitors are designed to harness
multiple components of the immune system to combat cancer. For more
information, please visit www.newlinkgenetics.com and follow us on
Twitter @NLNKGenetics.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements
of NewLink Genetics that involve substantial risks and
uncertainties. All statements contained in this press release are
forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. The words "may," “appear
to,” “has potential to,” “look forward to,” or the negative of
these terms or other similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. These forward-looking
statements include, among others, statements about results of
NewLink’s clinical trials for product candidates and any other
statements other than statements of historical fact. Actual results
or events could differ materially from the plans, intentions and
expectations disclosed in the forward-looking statements
that NewLink Genetics makes due to a number of important
factors, including those risks discussed in "Risk Factors" and
elsewhere in NewLink Genetics' Annual Report on Form 10-K
for the year ended December 31, 2017 and other reports
filed with the U.S. Securities and Exchange
Commission (SEC). The forward-looking statements in this press
release represent NewLink Genetics’ views as of the date
of this press release. NewLink Genetics anticipates that
subsequent events and developments will cause its views to change.
However, while it may elect to update these forward-looking
statements at some point in the future, it specifically disclaims
any obligation to do so. You should, therefore, not rely on these
forward-looking statements as representing NewLink
Genetics' views as of any date subsequent to the date of this
press release.
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Lisa MillerDirector of Investor RelationsNewLink
Genetics515-598-2555lmiller@linkp.com
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