Pegilodecakin Combined with Immunotherapy Drugs Shows Promise for Previously Treated Kidney and Lung Cancer Patients

Sep 26, 2019 | Immunotherapy, Kidney Cancer, Lung Cancer

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MD Anderson led a study along with a group of prominent investigators and ARMO Biosciences (Lilly), revealing that pegilodecakin, a first-in-class drug currently in clinical trials, has shown positive safety results and represents a possible option for patients with non-small cell lung cancer (NSCLC) and kidney cancer. The investigational drug was used in combination with pembrolizumab (Keytruda) and nivolumab (Opdivo)—two leading anti-PD-1 monoclonal antibodies.

Published in the September 25, 2019 online edition of The Lancet Oncology, the study assessed the safety and tolerability as well as maximal tolerated dose of pegilodecakin combination with the two top anti-PD-1 monoclonal antibodies while also identifying biomarkers to identify patients likely to respond to treatment.

The Study

Occurring from February 2015 to September 2017, 111 kidney cancer, NSCLC and melanoma patients with advanced malignant solid tumors participated. The most common side effects were anemia, low blood platelet counts and high triglycerides.

MD Anderson reported in a press release that objective responses were seen in 43% of NSCLC patients, 40% of kidney cancer patients and 10% of melanoma patients. The patients received the pegilodecakin with pembrolizumab and nivolumab until disease progression, toxicity necessitating treatment discontinuation, patient therapy or pegilodecakin alone after disease progression if the investigator determined that the patient would continue to benefit from the treatment.


As published in The Lancet Oncology, pegilodecakin with one of the top anti-PD-1 monoclonal antibodies had a manageable toxicity profile and preliminary antitumor activity. Hence, the investigational drug in combination with either pembrolizumab or nivolumab could possibly offer a new therapeutic opportunity for previously treated patients with renal cell carcinoma and non-small-cell lung carcinoma.

What is Pegilodecakin?

Pegilodecakin is a cancer therapy in development by ARMO Biosciences (bought by Eli Lilly in 2018). The investigational product is under study with several types of advanced cancers including pancreatic, non-small cell lung cancer, and renal cell carcinoma. Pegilodecakin has been designated as an orphan drug by both the FDA and EMA in combination with FOLFOX, a chemotherapy drug made up of folinic acid, 5-fluorouracil and oxaliplatin which is on fast track development as a second-line therapy for advanced pancreatic cancer, reports Immuno-Oncology News

Study Funders

The study was funded by Eli Lilly (ARMO Biosciences).

Lead Research/Investigator

Aung Naing, MD Anderson

Call to Action: Interested in learning more about this study? Aung Naing was the lead author and in the TrialSite Network—which includes a large, global investigator data base. Feel free to contact us for more information.