Date: 2016-05-09
Type of information: Results
phase: 3
Announcement: results
Company: NewLink Genetics (USA - IO)
Product: algenpantucel-L
Action
mechanism: immunotherapy product/therapeutic vaccine. Algenpantucel-L is an allogenic pancreatic cancer vaccine. It is comprised of two human pancreatic ductal adenocarcinoma cell lines (HAPa-1 and HAPa-2) that have been genetically engineered to express ?(1,3)- galactosyl epitopes (?Gal) by using retroviral transfer of the murine ?GT gene.
Disease: patients with resected pancreatic cancer
Therapeutic area: Cancer - Oncology
Country:
Trial
details: The IMmunotherapy for Pancreatic RESectable cancer Study (IMPRESS) trial is a randomized, controlled, two-arm Phase 3 trial for patients with resected pancreatic cancer testing algenpantucel-L (300M cells every two weeks for six months followed by every month for another six months) in combination with the standard of care versus standard of care alone.A total of 722 patients with surgically removed cancers were enrolled at more than 70 sites in the United States from May 2010 to September 2013.
Latest
news: * On May 9, 2016, NewLink Genetics announced results of its Phase 3 clinical trial for algenpantucel-L for patients with resected pancreatic cancer. The IMPRESS Phase 3 study of algenpantucel-L for patients with resected pancreatic cancer did not achieve its primary endpoint. Overall survival from time of randomization was 29.3 months for both groups combined. There was no statistically significant difference between the two groups. The median survival was 30.4 months and 27.3 months for the control and study groups, respectively. There was also no statistical difference for long-term survival. Three year survival was 41.4% and 42.1% and four year survival was 32.6% and 32.7% for the control and study groups, respectively. "Immunotherapy is rapidly establishing a role in the management of multiple malignancies," said George Fisher, M.D., Ph.D., Professor of Medicine at Stanford University, one of the investigators in the IMPRESS study. "The median overall survival of 29.3 months in this study represents a significant increase compared with prior trials and may be due to multiple factors, including the emergence of more effective treatment regimens for recurrent or metastatic disease. Although a negative study, these results represent an important and meaningful contribution to the understanding of the modern treatment of resected pancreatic cancer." "In light of these negative results, our scientific and clinical teams will focus on other promising opportunities in our pipeline," said Charles Link, Jr., M.D., Chairman and Chief Executive Officer. "Our lead projects focus on our IDO checkpoint inhibitor technology employing indoximod and GDC-0919. We have substantial near-term catalysts in 2016 for these IDO inhibitor programs, including multiple trial updates from our proprietary and partnered IDO pathway inhibitors, and the financial resources to realize the potential of our product pipeline." NewLink Genetics ended the first quarter on March 31, 2016, with cash, cash equivalents, and certificates of deposit totaling $178 million. The Company reiterates that its goal and expectation is to finish 2016 with two years of cash on hand.
