Study of Pegilodecakin (LY3500518) With Pembrolizumab Compared to Pembrolizumab Alone First-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer

Phase 2 Terminated 101 enrolled Eli Lilly and Company ARMO BioSciences · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

To compare the efficacy of pegilodecakin in combination with pembrolizumab versus pembrolizumab alone in participants with metastatic non-small cell lung cancer as measured by objective response rate.

Timeline

Start: 2018-03-19
Primary completion: 2019-12-06
Completion: 2020-03-05

Outcome

Missed primary endpoint

Stopped: “The CYPRESS-1 trial was closed early after the planned primary analysis because the risk benefit ratio is unfavorable.”

registry analysis (superiority test); Pegilodecakin + Pembrolizumab vs Pembrolizumab; p = 0.7626; Odds Ratio (OR) 1.1 (95% CI 0.5 to 2.5) NCT03382899 ↗

paper Despite evidence of biological effect in peripheral blood, adding pegilodecakin to CPI did not improve ORR, PFS, or OS PMID 33166722 ↗

Publications

Spigel D, Jotte R, Nemunaitis J, Shum M, Schneider J, Goldschmidt J, Eisenstein J, Berz D, Seneviratne L, Socoteanu M, Bhanderi V, Konduri K, Xia M, Wang H, Hozak RR, Gueorguieva I, Ferry D, Gandhi L, Chao BH, Rybkin I. Randomized Phase 2 Studies of Checkpoint Inhibitors Alone or in Combination With Pegilodecakin in Patients With Metastatic NSCLC (CYPRESS 1 and CYPRESS 2). J Thorac Oncol. 2021 Feb;16(2):327-333. doi: 10.1016/j.jtho.2020.10.001. Epub 2020 Nov 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pegilodecakin	Protein / enzyme biologic	0.8 mg	Subcutaneous
Subject	Pegilodecakin	Protein / enzyme biologic	1.6 mg	Subcutaneous
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous