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Lilly Says Phase 3 SEQUOIA Study Did Not Meet Primary Endpoint - Quick Facts

Eli Lilly and Co. (LLY) announced Wednesday that top-line results from its Phase 3 SEQUOIA trial evaluating pegilodecakin plus FOLFOX (folinic acid, 5-FU, oxaliplatin) compared to FOLFOX alone in patients with metastatic pancreatic cancer whose disease had progressed during or following a first-line gemcitabine-containing regimen. The SEQUOIA trial did not meet its primary endpoint of overall survival.

The primary endpoint of the study is overall survival and key secondary endpoints are progression-free survival and objective response rate. SEQUOIA was initiated by ARMO BioSciences in March 2017 and enrolled 567 patients.

Detailed efficacy and safety results will be submitted for presentation at a future medical meeting.

Pegilodecakin, a pegylated IL-10, is an immunotherapy which stimulates the body's natural defenses against cancer and expands tumor-attacking T cells. This class of T cells can infiltrate and destroy cancer cells.

Metastatic pancreatic cancer is one of the deadliest major cancers, with just three percent of patients in the U.S. living five years after the cancer is diagnosed. In the U.S., pancreatic cancer is the third leading cause of cancer death and is expected to become the second leading cause of cancer-related death in the next decade.

Pancreatic cancer has proven to be one of the most difficult tumor types to treat and there have been very few recent treatment advancements in the later-line metastatic setting.

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