First-in-Class Pegilodecakin Plus Immunotherapy Under Study in Lung Cancer
Posted: Tuesday, November 26, 2019
The first-in-class drug pegilodecakin in combination with the PD-1 inhibitors pembrolizumab or nivolumab produced an objective response in 43% of patients with advanced non–small cell lung cancer (NSCLC) and has a tolerable toxicity profile, according to a phase Ib 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 Ib trial, IVY, included 111 patients with advanced malignant solid tumors that were refractory to prior treatment. Of these patients, 34 had NSCLC, and 28 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 26.9 months for patients with NSCLC. The objective response rate was 43% in the 28 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 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.