Lilly’s Phase 3 SEQUOIA trial fail to meet primary endpoint for pegilodecakin plus Folfox compared to Folfox alone in patients with metastatic pancreatic cancer


Eli Lilly and Company proclaimed top-line results from its phase III SEQUOIA trial accessing pegilodecakin plus Folfox (folinic acid, 5-FU, oxaliplatin) in comparison to Folfox alone in patients with metastatic pancreatic cancer whose illness had progressed throughout or following a first-line gemcitabine-containing program. The SEQUOIA trial failed to meet its primary endpoint of overall survival.

Grade 3/4 adverse events which is common in occurrence at a higher rate (>5% difference) on the pegilodecakin-plus-Folfox arm in comparison to the Folfox arm were neutropenia, thrombocytopenia, fatigue and anemia.

Pegilodecakin was gained by Lily with the takeover of ARMO BioSciences in June 2018. SEQUOIA was commenced by ARMO in March 2017 based on results of the phase 1/1b IVY study, which examined pegilodecakin – utilized as a single agent and in combination with chemotherapy and with checkpoint inhibitor therapy – across multiple tumour types including pancreatic, non-small cell lung and renal cell cancers. For the next stage of pegilodecakin's clinical development, Lilly is determined on evaluating biomarkers and conducting studies in NSCLC and other tumour types including renal cell carcinoma, where the molecule has shown promising activity.