NewLink Genetics updates data from study of indoximod plus KEYTRUDA
NewLink Genetics 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. These data will be highlighted in an oral presentation at the Third International Cancer Immunotherapy Conference in Frankfurt/Mainz, Germany, on September 9, 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. 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 and the Overall Response Rate 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:Improvement in Complete Response to 20% compared to CR of 12%. The Progression-Free Survival by RECIST criteria was 56% at one year with median PFS of 12.9 months. 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 possibly attributed to indoximod. Three patients experienced SAEs that led to discontinuation of treatment. There were no treatment related deaths. The pivotal trial has been designed as a large-scale trial in Stage III unresectable and metastatic stage IV melanoma. The trial will have a one to one randomization between indoximod plus KEYTRUDA or OPDIVO compared to single agent PD-1 inhibitor. The co-primary endpoints of the study are PFS by RECIST criteria and Overall Survival.