Pegilodecakin Plus Pembrolizumab or Nivolumab in Advanced Solid Tumors

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In a phase Ib trial reported in The Lancet Oncology, Naing et al found that the combination of pegilodecakin (pegylated interleukin [IL]-10) with the programmed cell death protein 1 (PD-1) inhibitor pembrolizumab or nivolumab was active in previously treated advanced solid tumors. 

“In this patient population, pegilodecakin with anti–PD-1 monoclonal antibodies had a manageable toxicity profile and preliminary antitumour activity.”
— Naing et al

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In the study, 111 patients with refractory solid tumors from 12 U.S. centers were sequentially enrolled between February 2015 and September 2017 into two cohorts. All patients self-administered pegilodecakin at home via daily subcutaneous injection of 10 μg/kg or 20 μg/kg, and received pembrolizumab (2 mg/kg every 3 weeks or 200 mg every 3 weeks) in one cohort (n = 53) or nivolumab (3 mg/kg every 2 weeks or 240 mg every 2 weeks or 480 mg every 4 weeks) in another cohort (n = 58).

Treatment continued until disease progression, unacceptable toxicity, patient withdrawal, or study end. Objective response was assessed by immune-related response criteria.

Key Findings

Most patients had non–small cell lung cancer (NSCLC, n = 34; median follow-up = 26.9 months), melanoma (n = 37; median follow-up = 33.0 months), or renal cell carcinoma (n = 38; median follow-up = 22.7 months).

Among evaluable patients, objective response was observed in 12 (43%) of 28 patients with NSCLC, 3 (10%) of 31 with melanoma, and 14 (40%) of 35 with renal cell carcinoma. Median durations of response were 10.3 months in the NSCLC cohort and 15.1 months in the renal cell carcinoma cohort. 

Treatment-related grade 3 or 4 adverse events occurred in 66% of patients overall, including 66% of the pembrolizumab cohort and 66% of the nivolumab cohort. The most common treatment-related grade 3 or 4 adverse events were anemia (23% of pembrolizumab cohort and 28% of nivolumab cohort), thrombocytopenia (26% and 21%), fatigue (21% and 10%), and hypertriglyceridemia (6% and 14%). No deaths were considered related to treatment-related adverse events.

The investigators concluded: “In this patient population, pegilodecakin with anti–PD-1 monoclonal antibodies had a manageable toxicity profile and preliminary antitumour activity. Pegilodecakin with pembrolizumab or nivolumab could provide a new therapeutic opportunity for previously treated patients with renal cell carcinoma and [NSCLC].”

Aung Naing, MD, of The University of Texas MD Anderson Cancer Center, is the corresponding author for The Lancet Oncology article.

Disclosure: The study was funded by ARMO BioSciences, a wholly owned subsidiary of Eli Lilly and Company. For full disclosures of the study authors, visit

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.