SMR 2019: Vaccine Under Study to Prevent Recurrence in High-Risk Advanced Melanoma
Posted: Friday, December 13, 2019
A novel vaccine strategy may prevent recurrence in high-risk patients with stage III/IV resected melanoma, according to the primary analysis of a phase IIb trial presented at the 2019 International Congress of The Society for Melanoma Research (SMR) in Salt Lake City (late-breaking abstract). Mark Faries, MD, of the John Wayne Cancer Institute in Santa Monica, California, and colleagues found that the tumor lysate, particle-loaded, dendritic cell vaccine significantly improved disease-free survival in a subset of patients who completed the vaccine series on schedule.
The vaccine is a personalized treatment created by using a patient’s own tumor sample to develop autologous tumor lysate, which is loaded into yeast cell wall particles. In this prospective, randomized, double-blind, placebo-controlled trial, 103 patients received the vaccine, and 41 patients in the control group received unloaded yeast cell wall particles and autologous dendritic cells. The assigned treatment was given at 0, 1, 2, 6, 12, and 18 months.
No significant difference between the vaccine and placebo arms was reported for 24-month disease-free survival (38.5% vs. 27%, P = .974) or 24-month overall survival (86.4% vs. 75.1%, P = .15) in the intention-to-treat analysis. However, the 24-month disease-free survival in patients who completed the primary vaccine/placebo series was significantly improved in the vaccine group (62.9%) compared with placebo (34.8%).
As for safety, approximately one-third of patients who received the vaccine (35.9%) and served in the control arm (31.7%) experienced a treatment-related adverse event. More than 90% of these adverse events were grade 1 or 2.
Disclosure: For full disclosures of the study authors, visit societymelanomaresearch.org/congress.