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First Interim Analysis of Phase III SEQUOIA Trial in Pancreatic Cancer

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ARMO BioSciences, Inc, recently announced the completion of the first interim analysis in its phase III SEQUOIA trial in patients with pancreatic cancer. The Data Monitoring Committee (DMC) for SEQUOIA, a clinical trial studying pegilodecakin (AM0010) plus FOLFOX (leucovorin, fluorouracil [5-FU], oxaliplatin) vs FOLFOX alone in patients with pancreatic ductal adenocarcinoma, 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 whether 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.

“The DMC’s recommendation supports the safety profile we have seen with pegilodecakin when combined with 5-FU 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 [pancreatic ductal adenocarcinoma] 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,” said Joseph Leveque, MD, Chief Medical Officer of ARMO Biosciences.

More on SEQUOIA

SEQUOIA is a randomized clinical trial in patients with pancreatic ductal adenocarcinoma comparing 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, are both expected to be conducted in 2020.

The U.S. Food and Drug Administration (FDA) and European Commission have granted pegilodecakin Orphan Drug designation for the treatment of pancreatic cancer. 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 Pegilodecakin Immunotherapy

Pegilodecakin is a long-acting pegylated form of recombinant human interleukin-10 (IL-10), which exerts an anticancer effect by stimulating the survival, expansion, and cytotoxic potential of CD8-positive T cells. An abundance of tumor-infiltrating CD8-positive T cells is believed to improve the prognosis and lengthen the survival of cancer patients.

Results from a phase I/Ib clinical trial in over 350 patients with cancer demonstrated a good safety/tolerability profile for pegilodecakin and sustained antitumor effects across several different cancer types, including pancreatic cancer, renal cell carcinoma, non–small cell lung cancer, and others.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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