ARMO BioSciences Announces Positive Outcome of First Interim Analysis in SEQUOIA Phase 3 Pancreatic Cancer Study

posted in: News | 0

ARMO BioSciences Announces Positive Outcome of First Interim Analysis in SEQUOIA Phase 3 Pancreatic Cancer Study

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.

“Clearing the first interim analysis with feedback from the DMC to continue the SEQUOIA study without modifications is a key corporate milestone for ARMO in 2018,” said Joseph Leveque, MD, Chief Medical Officer of ARMO Biosciences.  “The DMC’s recommendation supports the safety profile we have seen with pegilodecakin when combined with 5-fluorouracyl and platinum based chemotherapy which is the basis for a number of difficult to treat cancers.  As such, we believe that pegilodecakin in combination with FOLFOX could provide a safe and efficacious therapeutic option for second-line PDAC patients.  The SEQUOIA study continues to enroll well and had 178 patients randomized as of March 15th of this year, which keeps us on track to deliver both the second interim analysis and the final data analysis on this pivotal study in 2020.”

SEQUOIA is a Phase 3 randomized pivotal clinical trial in PDAC patients, which compares a combination of pegilodecakin and FOLFOX to FOLFOX alone, as a second-line therapy after tumor progression during or following a gemcitabine-containing regimen. The first patient was enrolled in the study in early 2017 and the company plans to enroll approximately 566 patients in total.  The second interim analysis, as well as the final analysis, either of which could provide the basis for a Biologics License Application submission to the Food and Drug Administration (FDA), are both expected to be conducted in 2020.  The FDA and European Commission (EC) 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.

Press Release