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 thelancet.com.
