Combination Pegilodecakin with Anti-PD-1 Monoclonal Antibody Inhibitors Demonstrates Safety, OR for NSCLC

By Jeff Craven /alert Contributor
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Pegilodecakin with anti-programmed cell death protein 1 (PD-1) may be a viable therapy for patients with non-small-cell lung cancer (NSCLC), according to recent research published in The Lancet Oncology.

“Pegilodecakin with anti-PD-1 monoclonal antibodies had a manageable toxicity profile and promising anti-tumor activity,” Aung Naing, MD, associate professor of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center, stated in a press release. “Our study showed this combination demonstrated favorable response in NSCLC and kidney cancer patients who previously had been treated when compared to those treated with anti-PD-1 monoclonal antibodies alone.”


Lab Equipment. Source: Getty Images

Naing and colleagues performed a multi-cohort, open-label trial of 111 patients from 12 cancer research centers with NSCLC (n = 34) who received once-daily pegilodecakin with anti-PD-1 inhibitors pembrolizumab (n = 53), or nivolumab (n = 58) between February 2015 and September 2017. Patients were at least 18 years old with an Eastern Cooperative Oncology Group performance status of 0 or 1 and advanced malignant solid tumors that were refractory to treatment.

Pegilodecakin was administered once daily at 10 μg/kg or 20 μg/kg, pembrolizumab at a dose of 2 mg/kg every 3 weeks or 200 mg every 3 weeks, and nivolumab at a dose of 3 mg/kg every 2 weeks, 240 mg every 2 weeks, or 480 mg every 4 weeks until disease progression, discontinuation, consent withdrawal or the end of the study. Patients with NSCLC had a median follow-up of 36.9 months.

Overall, there was an objective response in 12 of 28 NSCLC patients (43%) and 14 of 35 RCC patients (40%), with available response data. The researchers reported 103 of 111 patients (93%) experienced one or more treatment-related adverse events, including grade 3 or grade 4 events in 35 of 53 patients receiving pembrolizumab (66%) and 38 of 58 patients receiving nivolumab (66%). The most common adverse events in both groups were anemia, thrombocytopenia, fatigue and hypertriglyceridaemia.  Naing and colleagues reported no treatment-related adverse events were fatal in any group.

“The activity of pegilodecakin in combination with anti-PD-1 monoclonal antibodies introduces a new class of drugs to the treatment of advanced solid tumors,” Dr. Naing said in the release. “Future randomized trials hopefully will determine the tolerability and clinical benefits of pegilodecakin as a single agent and in combinations in a range of cancers.”


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