Interim Phase 2 Data Demonstrate Robust Response Rate with Indoximod in Combination with Keytruda® (pembrolizumab) for Patie...
April 04 2017 - 8:30AM
NewLink Genetics Corporation (NASDAQ:NLNK), a biopharmaceutical
company focused on bringing novel immuno-oncology therapies to
patients with cancer, today reported interim results from NLG2103,
a Phase 2 study evaluating its IDO pathway inhibitor, indoximod, in
combination with checkpoint inhibitors for the treatment of
patients with advanced melanoma.
An infographic accompanying this release is
available
athttp://www.globenewswire.com/NewsRoom/AttachmentNg/f025a8a3-f8c5-4cf6-972b-e57312023126
These data report on a cohort of 60 evaluable patients
(including patients with ocular melanoma) who received the
combination of indoximod plus pembrolizumab which demonstrated a
52% (31/60) ORR and a 73% (44/60) DCR. Patients with non-ocular
melanoma achieved a 59% (30/51) ORR and an 80% (41/51) DCR. The
combination was generally well tolerated with low rates of Grade 3
or higher adverse events. These data will be presented today in the
Clinical Trials Plenary Session at the American Association for
Cancer Research (AACR) 2017 Annual Meeting in Washington, D.C.
“These data are impressive and demonstrate the potential of this
combination to improve response rates of the currently available
therapy for patients with advanced melanoma. Importantly, our
combination therapy was well tolerated without an appreciable
increase in toxicity,” said Dr. Yousef Zakharia, M.D., Assistant
Professor of Medicine, Division of Hematology, Oncology and Blood
& Marrow Transplantation at the University of Iowa and Holden
Comprehensive Cancer Center, a leading investigator on the
trial.
Nicholas Vahanian, M.D., President and Chief Medical Officer
said, “These new data further underscore the potential for
indoximod in combination with other agents. The ORR and DCR are
highly encouraging and further validate indoximod as a promising
IDO pathway inhibitor.”
Charles J. Link, Jr., M.D., Chairman and Chief Executive Officer
said, "Currently approved immunotherapies are transforming cancer
treatment. We believe targeting the IDO pathway is key to enhancing
the efficacy of existing and future treatment regimens. NewLink
Genetics has two distinct IDO pathway inhibitors in development
that represent separate and independent opportunities. We expect
further clinical validation of the IDO pathway as an
immuno-oncology target throughout 2017.”
NLG2103 is a Phase 2 study evaluating the addition of indoximod
to the standard of care checkpoint inhibitors approved for patients
with advanced melanoma (pembrolizumab, ipilimumab, or nivolumab).
The interim data represent a cohort of 60 evaluable patients who
received indoximod plus pembrolizumab. Evaluable patients were
defined as those having at least one on-treatment imaging study.
The primary outcome measure of the trial is objective response rate
(ORR) and secondary outcome measures include disease control rate
(DCR) and evaluation of safety and tolerability.
Key findings:
- The ORR, by site reported RECIST criteria, for all patients was
52% (31/60) with a 73% (44/60) DCR.
- Patients with non-ocular melanoma achieved a 59% (30/51) ORR
and a DCR of 80% (41/51).
- The majority of responses reported have been durable.
- The occurrence of Grade 3 or greater adverse events was low
with no apparent increase for the combination over what would be
expected with pembrolizumab alone.
About IndoximodIndoximod is an investigational,
orally available small molecule targeting the IDO Pathway. The IDO
Pathway is one of the key immuno-oncology targets involved in
regulating the tumor microenvironment and immune escape.
NewLink Genetics is currently evaluating indoximod in multiple
combination studies for patients with various types of cancer.
These include melanoma, acute myeloid leukemia, pancreatic cancer
and prostate cancer.
About NewLink Genetics CorporationNewLink
Genetics is a biopharmaceutical company at the forefront of
discovering, developing and commercializing novel immuno-oncology
product candidates to improve the lives of patients with
cancer. NewLink Genetics' product candidates are designed
to harness multiple components of the immune system to combat
cancer. For more information, please visit
http://www.newlinkgenetics.com.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc. (Source)
Cautionary Note Regarding Forward-Looking
StatementsThis press release contains forward-looking
statements of NewLink Genetics that involve substantial risks and
uncertainties. All statements, other than statements of
historical fact, contained in this press release are
forward-looking statements, within the meaning of The Private
Securities Litigation Reform Act of 1995. The words "anticipate,"
"believe," "estimate," "expect," "intend," "may," "plan," "target,"
"potential," "will," "could," "should," "seek" 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 its clinical trials for product candidates; its timing
of release of data from ongoing clinical studies; its plans related
to moving additional indications into clinical development; 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, 2016 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.
E-Media kit here
Investor Contacts:
Lisa Miller
Director of Investor Relations, NewLink Genetics
515-598-2555
lmiller@linkp.com
Beth Kurth
LaVoieHealthScience
617-374-8800, ext. 106
bkurth@lavoiehealthscience.com
Media:
Alison Chen
LaVoieHealthScience
617-374-8800, ext. 104
achen@lavoiehealthscience.com
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