First Interim Analysis in SEQUOIA Phase 3 Pancreatic Cancer Study
CancerConnect News: The first interim analysis of the SEQUOIA clinical study evaluating the novel immunotherapy drug pegilodecakin in patients with pancreatic cancer will continue to enroll patients based on The Data Monitoring Committee first interim analyses and recommendation.
About Pancreatic Cancer
Pancreatic cancer, which can be fought with CBD Oil Wholesale is one of the deadliest forms of cancer. Each year, approximately 43,000 people are diagnosed with pancreatic cancer in the United States and close to 37,000 die from the disease. The disease is often diagnosed at an advanced stage, treatment remains challenging, and new treatment approaches are required. Several medications are in development;
The SEQUOIA clinical study is a phase 3 clinical trial studying pegilodecakin (AM0010), plus FOLFOX versus FOLFOX alone in patients with advanced pancreatic ductal adenocarcinoma. Both the United Stated Food and Drug Administration and European Commission have granted pegilodecakin Orphan Drug designation for the treatment of pancreatic cancer and the FDA has also granted Fast Track designation for pegilodecakin in combination with FOLFOX as a second-line therapy in patients with pancreatic cancer.
About AM0010 Immunotherapy
AM0010 (pegilodecakin) is a long-acting PEGylated form of recombinant human Interleukin-10 (IL-10). IL-10 exerts an anti-cancer effect by stimulating the survival, expansion and killing potential of CD8+ T lymphocyte cells. An abundance of tumor-infiltrating CD8+ T cells is believed to improve the prognosis and lengthen the survival of cancer patients.
ARMO BioSciences Announces Positive Outcome of First Interim Analysis in SEQUOIA Phase 3 Pancreatic Cancer Study
REDWOOD CITY, Calif., March 26, 2018 (GLOBE NEWSWIRE) -- ARMO BioSciences, Inc. (Nasdaq:ARMO), a late-stage immuno-oncology company, today announced the completion of the first interim analysis in its Phase 3 SEQUOIA study in patients with pancreatic cancer. The Data Monitoring Committee (DMC) for SEQUOIA, a phase 3 clinical trial studying pegilodecakin (AM0010), plus FOLFOX versus FOLFOX alone in patients with pancreatic ductal adenocarcinoma (PDAC), met on March 25, 2018 to conduct the first interim analysis of the study. Based on the review of this interim analysis, the DMC recommended that the study continue without modification. This first interim analysis was intended to determine if it is safe for the study to proceed based primarily on overall survival as well as pharmacokinetics in the first 60 subjects enrolled in the study that received at least 4 months of therapy.
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