On September 7, 2017 NewLink Genetics Corporation (NASDAQ: NLNK) reported 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) (Press release, NewLink Genetics, SEP 7, 2017, View Source [SID1234520412]). These data will be highlighted in an oral presentation at the Third International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) 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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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 (Free AACR Whitepaper) 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 control
rate (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 (CIMT) (Free CIMT Whitepaper)
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.