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First-in-Class Pegilodecakin Under Study in Advanced Renal Tumors

By: Anna Nowogrodzki
Posted: Friday, November 8, 2019

The first-in-class drug pegilodecakin  in combination with the PD-1 inhibitors pembrolizumab or nivolumab produced an objective response in 40% of patients with advanced solid renal tumors and has a tolerable toxicity profile, according to a phase 1b trial. The research on this long-acting form of interleukin-10 linked to polyethylene glycol was published in The Lancet Oncology by Aung Naing, MD, of The University of Texas MD Anderson Cancer Center, and colleagues.

Pegilodecakin “had a manageable toxicity profile and promising antitumor activity,” said Dr. Naing in an MD Anderson press release. It “introduces a new class of drugs to the treatment of advanced solid tumors.”

The open-label phase 1b trial, IVY, included 111 patients with advanced malignant solid tumors refractory to prior treatment. Of these patients, 38 had renal cell carcinoma, and 35 of them were evaluable for response. Patients were recruited from 12 U.S. cancer research centers. The current study reports results from two sequential cohorts.

Patients self-administered pegilodecakin by subcutaneous injection at home once per day. In addition, clinicians administered either pembrolizumab every 3 weeks (53 of 111 patients) or nivolumab every 2 or 4 weeks (58 of 111 patients). Treatment continued until disease progression, cessation of treatment because of toxicity, patient withdrawal of consent, or the end of the study.

The median follow-up was 22.7 months for patients with renal cell carcinoma. The objective response rate was 40% in the 35 patients who were evaluable for response.

In the study as a whole, of the 111 patients who received at least one dose of pegilodecakin, 73 (66%) experienced grade 3 or 4 adverse events. The most common grade 3 or 4 adverse events were anemia, thrombocytopenia, fatigue, and hypertriglyceridemia. No fatal adverse events were found to be related to the study treatments.

Disclosure: The study was funded by Armo Biosciences. Dr. Naing has received travel and accommodation reimbursement from Armo Biosciences in addition to research funding for this study. For full disclosures of all study authors, visit thelancet.com.



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