A randomized phase 3 trial that evaluated the addition of pegilodecakin to FOLFOX for treatment of metastatic pancreatic cancer failed to meet its primary endpoint of OS, according to the agent’s manufacturer.
Pegilodecakin (AM0010, Eli Lilly), a long-acting form of pegylated interleukin-10, is designed to stimulate the body’s natural defenses against cancer and expands tumor-attacking T cells.
Prior studies suggested the agent has clinical activity as monotherapy for renal cancer, and may be effective in combination with chemotherapy and checkpoint inhibitor therapy in renal cell carcinoma, non-small cell lung cancer and other tumor types.
The global, multicenter SEQUOIA trial enrolled567 patients with metastatic pancreatic cancer whose disease progressed during or after a first-line gemcitabine-containing regimen. Patients received FOLFOX — which consists of folinic acid, 5-FU and oxaliplatin — alone or in combination with pegilodecakin.
OS served as the primary endpoint. Secondary endpoints included PFS and objective response rate.
Researchers observed no survival benefit in the pegilodecakin group, according to an Eli Lilly-issued press release.
The most common grade 3/grade 4 adverse events that occurred more frequently in the pegilodecakin group included neutropenia, thrombocytopenia, fatigue and anemia.
Detailed safety and efficacy results will be submitted for presentation at a medical meeting.
Eli Lilly obtained pegilodecakin through the acquisition of ARMO BioSciences in 2018.
Phase 2 trials are underway to evaluate the agent in combination with checkpoint inhibitors as treatment for NSCLC. Results are expected early in 2020.
“Pancreatic cancer has proven to be one of the most difficult tumor types to treat and there have been very few recent treatment advancements in the later-line metastatic setting,” Maura Dickler, MD, vice president for late phase development at Lilly Oncology, said in the release. “[Although] we are disappointed by the outcome of the SEQUOIA study, we look forward to the upcoming results in lung cancer, learning from those results and increasing our understanding of pegilodecakin’s novel mechanism of action in cancer immunotherapy.”