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NewLink Phase 2 breast cancer med misses endpoints

June 5, 2017

NewLink Genetics Corporation (NASDAQ: NLNK) today announced the results from a Phase 2 trial of indoximod in combination with taxane chemotherapy for patients with metastatic breast cancer.

Top line data from the study show that the trial did not meet its pre-specified endpoints of a statistically significant difference between the two treatment groups as to progression-free survival, overall survival or objective response rate.

“As demonstrated by multiple studies that have been reported since the start of this clinical trial, breast cancer unfortunately remains a challenging disease in immuno-oncology,” said Primary Investigator Hatem Soliman MD, Associate Member Breast, Tumor Biology, and Immunology Departments, Chair Clinical Research Advisory Committee, H. Lee Moffitt Cancer Center and Research Institute, Associate Professor, Division of Oncologic Sciences University of South Florida.

In this study, NLG2101, 169 first line metastatic breast cancer patients were selected to receive either docetaxel or paclitaxel by their treating physicians. Once the choice of backbone chemotherapy was made, patients were then randomized to receive either indoximod or placebo.

“We would like to thank all the patients, families, investigators, and research teams who supported the completion of this trial,” said Charles J. Link, Jr., M.D., Chairman and CEO of NewLink Genetics. “Independent of these results, we continue to be highly encouraged by indoximod as an IDO pathway inhibitor and look forward to future opportunities to share data from ongoing trials in multiple cancer types including melanoma, prostate cancer, acute myelogenous leukemia, and pancreatic cancer.”


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