Merck KGaA says that it has begun a late-stage study of its cancer vaccine Stimuvax which will assess its efficacy and safety as a potential treatment for patients with unresectable stage III non-small cell lung cancer.
Enrollment in the Phase III study, called START, will involve more than 1,300 patients in around 30 countries, is now open to patients in the USA, where the first randomisation has occurred. The company noted that currently, there are no approved maintenance therapies for patients responding to first-line treatment for unresectable stage III NSCLC.
Dr Frances Shepherd of Princess Margaret Hospital in Toronto, Canada and lead investigator of the START study, said that patients with advanced lung cancer “are in need of new therapies that effectively target cancer cells while providing better safety and tolerability." She added that “novel therapeutic vaccines such as Stimuvax may help the body's immune system identify and destroy cancer cells without targeting normal, healthy cells."
News of the study has triggered an undisclosed milestone payment to Canada’s Biomira which developed the vaccine