Adding immunotherapy pegylated IL-10 (pegilodecakin) to folinic acid, fluorouracil and oxaliplatin (FOLFOX) in patients with advanced gemcitabine-refractory pancreatic cancer does not improve overall survival, according to the SEQUOIA trial. "The trial, unfortunately, was negative, showing just how difficult pancreatic cancer is as a target and how much we need to learn about it and why immunotherapy doesn't work in this disease," Dr. J. Randolph Hecht of the David Geffen School of Medicine at UCLA told Reuters Health by email. "This disease will soon be the second most common cause of cancer death," he noted. Immune activation has been previously observed with pegilodecakin across tumor types, and the drug has shown promising results in metastatic pancreatic ductal adenocarcinoma, Dr. Hecht and his colleagues note in the Journal of Clinical Oncology. To investigate further, the researchers enrolled 567 patients at 133 study sites in a worldwide phase-3 trial. All were at least 18 years of age and had received only one prior gemcitabine-containing treatment (gemcitabine plus nab paclitaxel). No other prior therapy was permitted. Participants were randomized to treatment with FOLFOX alone or in combination with pegilodecakin. Median follow-up overall was close to 15 months. Median overall survival in the FOLFOX-alone group (6.3 months) was similar to that in the combination group (5.8 months). There was also no improvement in overall response rate or progression-free survival. In addition, although manageable, overall toxicity was higher with the combination treatment than with FOLFOX alone. Among grade-3 adverse events that had an increased incidence of 5% or more were thrombocytopenia (25.2% vs. 3.6%), anemia (16.2% vs. 4.0%) and fatigue (17.6% vs. 10.8%). —David Douglas Source
