logo
Plus   Neg
Share
Email
Comment

NewLink Genetics Reveals Positive Results From Its Phase-2 Immunotherapy Trial

NewLink Genetics Corporation (NLNK) Monday revealed then results of its 0ne-year, two-year and three-year overall survival data from its Phase-2 HyperAcute Pancreas Immunotherapy trial.

The multi-institutional, open-label, dose-finding, Phase 2 trial evaluated the use of algenpantucel-L in addition to chemotherapy with chemoradiotherapy in the adjuvant setting for resected pancreatic cancer.

The company stated that the study results show 37%, 59% and 121% improvement in 1-, 2- and 3-year survival, respectively, as compared to standard-of-care.

The company stated that the primary endpoint of the study, 12-month disease free survival (DFS), was 62%. The median DFS was 14.1 months. Subgroup analysis showed that patients receiving 300 million cells/dose had a 12-month DFS of 81%, while those receiving 100 million cells/dose had a 12-month DFS of 51%.

The results of the trial revealed that the Overall 12-month survival was 86%. The predicted 12 month overall survival in our study was 63%. Subgroup analysis showed that patients receiving 300 million cells/dose had an overall 12-month survival of 96%, while those receiving 100 million cells/dose had an overall 12-month survival of 79%. Two-year overall survival in our study was 51% with a predicted survival of 32% and 3-year overall survival was 42% with a predicted survival of 19%.

NewLink Genetics further added that the HyperAcute Pancreas immunotherapy product candidate, also referred to as algenpantucel-L, demonstrated good tolerability and a favorable safety profile with no grade four adverse events considered attributable to the immunotherapy.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Amazon.com Inc. (AMZN) said Thursday that it has chosen the 20 metropolitan areas to move to the next phase of the selection process for the company's second headquarters. The company plans to invest over $5 billion and grow the second headquarters to accommodate as many as 50,000 high-paying jobs. Morgan Stanley (MS) reported net income applicable to company of $686 million, or $0.29 per share for the fourth quarter ended December 31, 2017. The results for the current quarter included a net discrete tax provision of $990 million or a loss of $0.55 per share. Excluding net discrete tax items, net... Cannae Holdings, Inc. said Wednesday that its portfolio company, Ceridian HCM Holding Inc., has confidentially filed for an initial public offering. Ceridian HCM, a provider of human resources software and services, filed a draft registration statement on Form S-1 to the U.S. Securities and Exchange Commission relating to the proposed IPO of its common stock.
comments powered by Disqus
Follow RTT