Pivotal Trial of Indoximod in Advanced Melanoma
to Include Both PD-1 Inhibitors, KEYTRUDA (pembrolizumab) and
OPDIVO® (nivolumab)
NewLink Genetics Corporation (NASDAQ: NLNK) today announced
updated data from the ongoing Phase 2 NLG2103 study of indoximod,
NewLink Genetics’ IDO pathway inhibitor, in combination with the
PD-1 pathway inhibitor, KEYTRUDA (pembrolizumab). These data will
be highlighted in an oral presentation at the Third International
Cancer Immunotherapy Conference in Frankfurt/Mainz, Germany, on
September 9, 2017 by 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.
This Smart News Release features multimedia.
View the full release here:
http://www.businesswire.com/news/home/20170907005441/en/
Indoximod plus pembrolizumab data from
Phase 2 trial in advanced melanoma (Graphic: Business Wire)
The presentation entitled, “Combined Inhibition of the IDO and
PD-1 Pathways Improves the Response Rate for Patients with Advanced
Melanoma", showed an improvement over previously reported results
presented at the AACR Annual Meeting 2017 for both the Complete
Response rate (CR) and the Overall Response Rate (ORR) for
patients1 who received indoximod plus pembrolizumab. Evaluable
patients were defined as those having at least one on-treatment
imaging study.
Key findings in the updated data reported today:
- Improvement in Complete Response (CR)
to 20% (10/51 patients) compared to CR of 12% (6/51 patients)
- The Progression-Free Survival (PFS) by
RECIST criteria was 56% at one year with median PFS (mPFS) of 12.9
months
“We are encouraged by the progression-free survival and the
improvement in complete responses observed in the trial,” said
Charles J. Link, Jr., M.D., Chairman, Chief Executive Officer, and
Chief Scientific Officer. “The updated data further support our
decision to initiate a pivotal trial for patients with advanced
melanoma.”
Indoximod plus Pembrolizumab Data from Phase 2 Trial in Advanced
Melanoma n1 = 51 patients n (%)
ORR 31 (61) CR 10
(20) PR 21 (41) SD 10 (20)
DCR 41 (80) PD 10 (20)
mPFS (months) 12.9 PFS at 12 months 56%
overall response rate (ORR), complete
response (CR), partial response (PR), stable disease (SD), disease
controlrate (DCR), progressive disease (PD), median
progression-free survival (mPFS), progression-free survival
(PFS)
1 Update includes only those patients with cutaneous, mucosal and
melanoma of unknown primary origin. Data as presented at Third
International Cancer Immunotherapy Conference
Indoximod in combination with pembrolizumab was well-tolerated.
The most common all-grade adverse events were fatigue,
headache, and nausea. Three patients experienced grade 3 serious
adverse events (SAE) possibly attributed to indoximod. Three
patients experienced SAEs that led to discontinuation of treatment.
There were no treatment related deaths.
Pivotal Trial of Indoximod in Advanced Melanoma to Include
Both PD-1 Inhibitors, KEYTRUDA (pembrolizumab) and OPDIVO
(nivolumab)
The pivotal trial has been designed as a large-scale (600
patients) trial in Stage III unresectable and metastatic stage IV
melanoma. The trial will have a one to one randomization between
indoximod plus KEYTRUDA (pembrolizumab) or OPDIVO (nivolumab)
compared to single agent PD-1 inhibitor. The co-primary endpoints
of the study are PFS by RECIST criteria and Overall Survival
(OS).
“Our team is excited to move forward with this pivotal trial,”
said Eugene Kennedy, M.D., Vice President of Clinical and Medical
Affairs. “We believe that allowing physicians the choice of either
pembrolizumab or nivolumab accurately reflects current clinical
care and should aid in enrolling the trial by the end of 2018.”
About Indoximod
Indoximod 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
including melanoma, acute myeloid leukemia, pancreatic cancer and
prostate cancer.
About NewLink Genetics Corporation
NewLink Genetics is a late-stage biopharmaceutical company
focusing on discovering, developing and commercializing 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. Indoximod is being evaluated in combination with treatment
regimens including anti-PD-1 agents, cancer vaccines, and
chemotherapy across multiple indications such as melanoma, prostate
cancer, acute myeloid leukemia, and pancreatic 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.
OPDIVO® is a registered trademark of Bristol-Myers Squibb
Company.
Cautionary Note Regarding Forward-Looking Statements
This 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 any 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170907005441/en/
Investor Contact:NewLink GeneticsLisa Miller,
515-598-2555Director of Investor
Relationslmiller@linkp.comorMedia:LaVoieHealthScienceAndrew
Mastrangelo, 617-374-8800, ext. 108AVP, Public & Media
Relationsamastrangelo@lavoiehealthscience.com
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