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

Summary

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

Timeline

Start

2018-03-22

Primary completion

2019-08-28

Completion

2020-03-03

Outcome

Missed primary endpoint

Stopped: “The CYPRESS-2 trial was closed early after the planned final analysis because the risk benefit ratio is unfavorable.”

registry analysis (superiority test); Pegilodecakin + Nivolumab vs Nivolumab; Odds Ratio (OR) 1.2 (95% CI 0.3 to 5.9) NCT03382912 ↗

paper Despite evidence of biological effect in peripheral blood, adding pegilodecakin to CPI did not improve ORR, PFS, or OS, in first-line/second-line NSCLC. 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.
• Albrethsen M, Creeden J, Morand S, DeBiase J, Berry B, Stanbery L, Edelman G, Nemunaitis J. Relationship of hypothyroidism and immune response to pegylated IL-10/nivolumab. Immunotherapy. 2020 Oct;12(14):1041-1046. doi: 10.2217/imt-2020-0016. Epub 2020 Aug 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nivolumab	Monoclonal antibody	240 mg	Intravenous
Subject	Nivolumab	Monoclonal antibody	480 mg	Intravenous
Subject	Pegilodecakin	Protein / enzyme biologic	0.8 mg	Subcutaneous
Subject	Pegilodecakin	Protein / enzyme biologic	1.6 mg	Subcutaneous

Indications