Eli Lilly has reported that the Phase III SEQUOIA clinical trial of pegilodecakin failed to meet the primary endpoint of overall survival in patients with metastatic pancreatic cancer.
Pegilodecakin is an immunotherapy designed to induce the body’s response against cancer and boost tumour-attacking T cells.
The global, multi-centre, randomised, Phase III SEQUOIA trial compared pegilodecakin and Folfox combination to Folfox alone in 567 patients who had progressed on or after a first-line gemcitabine-containing regimen.
SEQUOIA was started in March 2017 by Armo BioSciences, which was acquired by Lilly in June last year.
The primary endpoint of the trial is overall survival, while key secondary endpoints include progression-free survival and objective response rate.
The most common grade three/four adverse events related to pegilodecakin and Folfox combination were anaemia, neutropenia, thrombocytopenia and fatigue.
The incidence of these adverse events was observed to be higher in patients treated with the combination versus Folfox alone.
Lilly Oncology late-phase development vice-president Maura Dickler said: “Pancreatic cancer has proven to be one of the most difficult tumour types to treat and there have been very few recent treatment advancements in the later-line metastatic setting.
“While we are disappointed by the outcome of the SEQUOIA study, we look forward to the upcoming results in lung cancer, learning from those results and increasing our understanding of pegilodecakin’s novel mechanism of action in cancer immunotherapy.”
The SEQUOIA study is based on data obtained from the Phase I/Ib IVY trial, where pegilodecakin was assessed as a monotherapy and in combination with chemotherapy and with checkpoint inhibitor therapy in various cancers, including pancreatic cancer.
Pegilodecakin is also currently evaluated in combination with checkpoint inhibitors in Phase II CYPRESS 1 and CYPRESS 2 trials involving non-small cell lung cancer (NSCLC) patients.