NewLink Genetics Announces Final Results from Two Phase 2 Studies of Indoximod Presented at ASCO 2018
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“Our data in advanced melanoma suggest that indoximod in combination
with checkpoint blockade shows encouraging response rates potentially in
both PD-L1 positive and negative patients,” said
Indoximod in combination with checkpoint inhibition in advanced melanoma
Results from a single-arm Phase 2 study of indoximod in combination with
checkpoint inhibitors for patients with advanced melanoma were presented
today by
In this study, of 102 total patients enrolled, 101 patients with advanced melanoma were treated with indoximod plus standard-of-care checkpoint inhibition as approved for melanoma. 70 patients with cutaneous or mucosal melanoma were treated with pembrolizumab plus indoximod and had an on-treatment imaging, meeting the per-protocol, pre-specified definition of evaluable for efficacy. Of the remaining 32 patients, 15 had uveal melanoma, 4 received ipilimumab, 4 received nivolumab, and one patient was never treated. In addition, 8 patients came off study prior to the first on-treatment imaging study. The full data set, including the expanded biopsy cohort, is provided on the company’s website in the “Posters & Presentations” section under the “Investors & Media” tab.
Key findings from the 70 evaluable for efficacy patients presented from the study include:
- ORR for combination therapy of 56%
- CR of 19%
- Median PFS of 12.4 months
- PD-L1 ≥ 1% staining of 54% (22/41 patients with archival tissue)
-
ORR by PD-L1 status
- PD-L1 (+) patients: ORR of 77%
- PD-L1 (-) patients: ORR of 42%
- Combination was well tolerated
Indoximod in combination with chemotherapy in metastatic pancreatic cancer
Results from a Phase 2 study of indoximod plus chemotherapy for patients
with metastatic pancreatic cancer were presented at
About Indoximod
Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target involved in regulating the tumor microenvironment and immune escape. Indoximod is being evaluated in combination with treatment regimens including chemotherapy, radiation, checkpoint blockade and cancer vaccines across multiple indications such as AML, DIPG and melanoma.
About NewLink Genetics Corporation
NewLink Genetics is a clinical stage biopharmaceutical company focusing
on discovering, developing and commercializing novel immuno-oncology
product candidates to improve the lives of patients with cancer.
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 "guidance," "upcoming," "will," "plan,"
“intend,” "anticipate," "approximate," "expect," 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 NewLink Genetics' financial
guidance for 2018; results of its clinical trials for product
candidates; its timing of release of data from ongoing clinical studies;
its plans related to execution of clinical trials; plans related to
moving additional indications into clinical development; NewLink
Genetics' future financial performance, results of operations, cash
position and sufficiency of capital resources to fund its operating
requirements; 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 (
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Source:
Investor Contact:
NewLink Genetics
Lisa Miller, 515-598-2555
Director
of Investor Relations
lmiller@linkp.com
or
Media
Contact:
LaVoieHealthScience
Sharon Correia, 617-374-8800,
ext. 105
VP, Integrated Communications
scorreia@lavoiehealthscience.com