Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer

Phase 3 Completed 567 enrolled Eli Lilly and Company ARMO BioSciences · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

To compare the efficacy of pegilodecakin in combination with FOLFOX versus FOLFOX alone in participants with metastatic pancreatic cancer as measured by overall survival.

Timeline

Start: 2017-03-01
Primary completion: 2019-09-09
Completion: 2020-03-05

Outcome

Missed primary endpoint

registry analysis (superiority test); Pegilodecakin + FOLFOX vs FOLFOX; p = 0.6565; Hazard Ratio (HR) 1.045 (95% CI 0.863 to 1.265); Log Rank NCT02923921 ↗

paper OS was similar comparing PEG + FOLFOX versus FOLFOX (median: 5.8 v 6.3 months; hazard ratio = 1.045; 95% CI, 0.863 to 1.265). PMID 33555926 ↗

release “The SEQUOIA trial did not meet its primary endpoint of overall survival.” lilly.com ↗

Publications

Hecht JR, Lonardi S, Bendell J, Sim HW, Macarulla T, Lopez CD, Van Cutsem E, Munoz Martin AJ, Park JO, Greil R, Wang H, Hozak RR, Gueorguieva I, Lin Y, Rao S, Ryoo BY. Randomized Phase III Study of FOLFOX Alone or With Pegilodecakin as Second-Line Therapy in Patients With Metastatic Pancreatic Cancer That Progressed After Gemcitabine (SEQUOIA). J Clin Oncol. 2021 Apr 1;39(10):1108-1118. doi: 10.1200/JCO.20.02232. Epub 2021 Feb 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pegilodecakin	Protein / enzyme biologic	0.8 mg	Subcutaneous
Subject	Pegilodecakin	Protein / enzyme biologic	1.6 mg	Subcutaneous
Background	Oxaliplatin	Small molecule	85 mg/m2	—
Background	dl-Leucovorin	Unknown	400 mg/m2	—
Background	fluorouracil	Small molecule	400 mg/m2	—
Background	fluorouracil	Small molecule	2400 mg/m2	—