ARMO Biosciences’ immunotherapy candidate pegilodecakin (AM0010) was seen to be safe in the first interim analysis of a Phase 3 trial evaluating it as a possible treatment of metastatic pancreatic cancer, ensuring that the trial can proceed.
According to the data monitoring committee (DMC) overseeing the study and responsible for monitoring patients’ safety, interim results support continuing the trial without modifications.
Pegilodecakin consists on a form of human interleukin-10 (IL-10), a messenger molecule that exerts an anti-cancer effect by promoting the growth and killing activity of T-cells, a type of immune cell. This particular form of IL-10 is linked to a molecule called polyethylene glycol that prolongs the time IL-10 stays in circulation, enabling the therapy to have a long-acting effect.
In a Phase 1/1b clinical trial (NCT02009449) in 350 patients with more than 14 different types of advanced solid cancers, treatment with pegilodecakin increased T-cell activation and induced tumor responses. It was given as a single agent or in combination with chemotherapy or anti-PD-1 checkpoint inhibitors.
The Phase 3 trial, called SEQUOIA (NCT02923921), aims to compare the efficacy of pegilodecakin in combination with FOLFOX chemotherapy versus FOLFOX alone in patients with metastatic pancreatic ductal adenocarcinoma. It is being tested as a second-line therapy in people whose cancer has progressed during or after gemcitabine, a chemotherapy.
This first interim analysis was based on the overall survival and exposure levels (pharmacokinetics) in 60 patients treated with pegilodecakin for at least four months.
“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,” Joseph Leveque, MD, ARMO’s chief medical officer, said in a news release.
“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,” he added.
SEQUOIA is currently enrolling eligible patients at some 135 study sites across the U.S., Australia, Canada and Europe. More information is available by clicking here or on the trial’s NCT number, given above.
Both a second interim and final data analysis are expected in 2020, and may be used to support a Biologics License Application to the U.S. Food and Drug Administration (FDA).
The FDA and the European Commission (EC) have designated pegilodecakin an orphan drug as a potential pancreatic cancer treatment. The FDA also granted it Fast Track status, in combination with FOLFOX chemotherapy, to speed its development as a possible second-line therapy for pancreatic cancer.
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