FDA, Polynoma Agree on Study for Melanoma Vaccine

FDA and Polynoma have reached agreement under a Special Protocol Assessment on a pivotal Phase 3 clinical trial of the company’s melanoma cancer vaccine seviprotimut-L and its use as an adjuvant treatment for patients 60 years and younger with Stage IIB or IIC melanoma following definitive surgical resection to improve recurrence-free survival. Seviprotimut-L previously received a fast track designation from the agency.

Recently published data from the Melanoma Antigen Vaccine Immunotherapy Study showed the vaccine’s clinically significant improvement in recurrence-free survival, which reduced the risk of disease recurrence or death by 68% compared to patients receiving placebo, according to the company. Additionally, recurrence-free survival was more favorable in patients under age 60 with ulcerated melanomas, and there was a trend toward improved overall survival for patients that received seviprotimut-L compared to those receiving placebo, it adds.