Pivotal Trial of Indoximod in Advanced Melanoma to Include Both PD-1
Inhibitors, KEYTRUDA (pembrolizumab) and OPDIVO®
AMES, Iowa--(BUSINESS WIRE)--
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.
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Indoximod plus pembrolizumab data from Phase 2 trial in advanced melanoma (Graphic: Business Wire)
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
n1 = 51 patients
PFS at 12 months
overall response rate (ORR), complete response (CR), partial
response (PR), stable disease (SD), disease control
(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
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."
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170907005441/en/
Lisa Miller, 515-598-2555
of Investor Relations
Mastrangelo, 617-374-8800, ext. 108
AVP, Public & Media Relations
Source: NewLink Genetics Corporation
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